This document describes the design and development of a cold chain monitoring system for vaccines. The system was created to ensure vaccine safety by strictly monitoring temperature from production to usage and allowing information sharing between all entities involved. It includes modules for vaccine suppliers, manufacturers, logistics providers, medical facilities, and functions for temperature monitoring, emergency reporting, and inspections. The system establishes authority levels and data access controls. It was tested using scenarios involving temperature deviations and ineffective vaccines to demonstrate how the system could quickly identify issues and improve safety oversight of vaccines. The goal is to implement such a system in Taiwan to better manage vaccine quality and trace any problems.
How Will the Updated EudraVigilance System Impact Pharma Companies and the In...Covance
The EudraVigilance system is used to manage and analyse information on suspected adverse reactions to medicines that need to be reported in the European Union. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
A Perspective Study of Warning Letters on Data Integrity Issued by FDA betwee...ijtsrd
Data integrity credential is a good stride to the pharmaceutical industry and also helps for the prospective market growth of the industry by increasing the public trust, reputation. Data integrity is a head way for maintaining quality systems and controlling deviations, minimizing errors that occur frequently in the industry. It ensures the lab records and good outcome in inspections, audits, and to get excellent market division in terms of share and also makes the industry flawless. Data integrity includes the complete, consistent data that should be attributable, legible, contemporaneous, and original, accurate data and should be recorded and maintained in depth periodically. This article mainly emphasizes on the approaches for data integrity, background, challenges faced by company, consequences of data integrity failures, remediation measures for data integrity, new FDA Food and Drug Administration guidelines on data integrity.In order to ensure data integrity in industry quality culture should be maintained, electronic signatures, personnel, giving training to employees to ensure quality system in the industry. Sai Sindhu P | Koushik Y | Rama Rao N "A Perspective Study of Warning Letters on Data Integrity Issued by FDA between 2017 and 2019" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-4 , June 2020, URL: https://www.ijtsrd.com/papers/ijtsrd31354.pdf Paper Url :https://www.ijtsrd.com/pharmacy/other/31354/a-perspective-study-of-warning-letters-on-data-integrity-issued-by-fda-between-2017-and-2019/sai-sindhu-p
Pharmacovigilance Training in Oracle Argus Safety Database with ProjectBioMed Informatics
Pharmacovigilance Training in Oracle Argus Safety Database with Project
BioMed Informatics Medwin Hospitals
BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety, SAS Clinical, IPR & Regulatory Affairs trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.
Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.
Mode of Training: Instructor Led Class room/Online Training
Online Training Features:
Web based classroom
One faculty/student
Placement support
Regular/Fast track/Weekend batches
Flexible timings
Training Mode: Skype/Teamviewer
Hands-On Training on the Database
Direct access to Oracle Argus Safety Database
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.
Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace.
Pharmaceutical Data Process Manufacturing Software
Pharmaceutical Data Process Manufacturing Software
Pharmaceutical Data Process Manufacturing Software
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
As per the USFDA guidelines there are about 38 drugs has banned in India due to poor handling of DATA INTEGRITY SYSTEMS. We at Marcep Inc. proud to announce the need of an hour by organizing the above mentioned training program.
Register early as all the locations are fast filling to avoid disappointment.
How Will the Updated EudraVigilance System Impact Pharma Companies and the In...Covance
The EudraVigilance system is used to manage and analyse information on suspected adverse reactions to medicines that need to be reported in the European Union. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
A Perspective Study of Warning Letters on Data Integrity Issued by FDA betwee...ijtsrd
Data integrity credential is a good stride to the pharmaceutical industry and also helps for the prospective market growth of the industry by increasing the public trust, reputation. Data integrity is a head way for maintaining quality systems and controlling deviations, minimizing errors that occur frequently in the industry. It ensures the lab records and good outcome in inspections, audits, and to get excellent market division in terms of share and also makes the industry flawless. Data integrity includes the complete, consistent data that should be attributable, legible, contemporaneous, and original, accurate data and should be recorded and maintained in depth periodically. This article mainly emphasizes on the approaches for data integrity, background, challenges faced by company, consequences of data integrity failures, remediation measures for data integrity, new FDA Food and Drug Administration guidelines on data integrity.In order to ensure data integrity in industry quality culture should be maintained, electronic signatures, personnel, giving training to employees to ensure quality system in the industry. Sai Sindhu P | Koushik Y | Rama Rao N "A Perspective Study of Warning Letters on Data Integrity Issued by FDA between 2017 and 2019" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-4 , June 2020, URL: https://www.ijtsrd.com/papers/ijtsrd31354.pdf Paper Url :https://www.ijtsrd.com/pharmacy/other/31354/a-perspective-study-of-warning-letters-on-data-integrity-issued-by-fda-between-2017-and-2019/sai-sindhu-p
Pharmacovigilance Training in Oracle Argus Safety Database with ProjectBioMed Informatics
Pharmacovigilance Training in Oracle Argus Safety Database with Project
BioMed Informatics Medwin Hospitals
BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety, SAS Clinical, IPR & Regulatory Affairs trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.
Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.
Mode of Training: Instructor Led Class room/Online Training
Online Training Features:
Web based classroom
One faculty/student
Placement support
Regular/Fast track/Weekend batches
Flexible timings
Training Mode: Skype/Teamviewer
Hands-On Training on the Database
Direct access to Oracle Argus Safety Database
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.
Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace.
Pharmaceutical Data Process Manufacturing Software
Pharmaceutical Data Process Manufacturing Software
Pharmaceutical Data Process Manufacturing Software
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
As per the USFDA guidelines there are about 38 drugs has banned in India due to poor handling of DATA INTEGRITY SYSTEMS. We at Marcep Inc. proud to announce the need of an hour by organizing the above mentioned training program.
Register early as all the locations are fast filling to avoid disappointment.
Data Integrity Issues in Pharmaceutical CompaniesPiyush Tripathi
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
Role of computer in clinical developmentDivyaShukla61
computers have always played a crucial role in our daily lives, Here i have presented its role in Clinical development.Hope you understand easily from my presentaion.
HySynth Biotechnologies’s Pharmacovigilance group provides a range of tailored Pharmacovigilance (PV) and Biovigilance (Hemovigilance) services that can effectively address the needs of biopharmaceutical companies of all sizes.
With people over 10 years of medical, technology and compliance expertise, we are able to provide diligently managed, flexible and cost-effective solutions.
With a full suite of scalable and flexible solutions, we can provide tools and techniques to achieve patient safety, regulatory compliance and long-term strategic advantage.
Our service packages are customized as per requisite of the organization and delivered through a lean operational model which includes, Triage till Medical Review, Case Processing, Case Reporting, Single Case Narrative writing, Aggregate Report writing, Literature Search, etc.
Medical Analysis:
- AE and SAE evaluations
- MedDRA and WHO-DD Coding
- SAE narrative writing
- Causality and Labeling Assessments
- Physician medical review and signal detection
- Literature reviews and summaries
- Updating CCDS and other Core documents
Regulatory Reporting:
- Expedited Reporting: Generation of MedWatch 3500A/CIOMS I forms
- Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
- Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports via E2B and Paper mail.
ICSR Processing:
The processing of individual case safety reports (ICSRs) originating from various sources which includes,
Post-marketing non-solicited/ Spontaneous reports
Clinical Reports
Special reports (Medico-legal, Literature & E2B)
Related Sources
Following established guidelines, data from source documents sent by clients are processed (data entry, MedDRA coding and safety narrative) in to a Drug Safety/Pharmacovigilance database, after a duplicate check.
This involves an initial triage followed by Data processing and a subsequent medical review by a physician. After the review process, the case reports are submitted to the regulatory authorities/business partners.
HySynth’s people have extensive experience across all case types and have worked with all commercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace and proprietary client databases.
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Presentation: Data Integrity – an international regulatory perspectiveTGA Australia
This presentation will provide an overview of the international regulatory perspective on data integrity and discuss some of the key points highlighted in recently released guidance documents from across the globe.
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
The IDMP Challenge - Whitepaper on ISO IDMP by CunesoftV E R A
The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
Data Integrity Issues in Pharmaceutical CompaniesPiyush Tripathi
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
Role of computer in clinical developmentDivyaShukla61
computers have always played a crucial role in our daily lives, Here i have presented its role in Clinical development.Hope you understand easily from my presentaion.
HySynth Biotechnologies’s Pharmacovigilance group provides a range of tailored Pharmacovigilance (PV) and Biovigilance (Hemovigilance) services that can effectively address the needs of biopharmaceutical companies of all sizes.
With people over 10 years of medical, technology and compliance expertise, we are able to provide diligently managed, flexible and cost-effective solutions.
With a full suite of scalable and flexible solutions, we can provide tools and techniques to achieve patient safety, regulatory compliance and long-term strategic advantage.
Our service packages are customized as per requisite of the organization and delivered through a lean operational model which includes, Triage till Medical Review, Case Processing, Case Reporting, Single Case Narrative writing, Aggregate Report writing, Literature Search, etc.
Medical Analysis:
- AE and SAE evaluations
- MedDRA and WHO-DD Coding
- SAE narrative writing
- Causality and Labeling Assessments
- Physician medical review and signal detection
- Literature reviews and summaries
- Updating CCDS and other Core documents
Regulatory Reporting:
- Expedited Reporting: Generation of MedWatch 3500A/CIOMS I forms
- Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
- Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports via E2B and Paper mail.
ICSR Processing:
The processing of individual case safety reports (ICSRs) originating from various sources which includes,
Post-marketing non-solicited/ Spontaneous reports
Clinical Reports
Special reports (Medico-legal, Literature & E2B)
Related Sources
Following established guidelines, data from source documents sent by clients are processed (data entry, MedDRA coding and safety narrative) in to a Drug Safety/Pharmacovigilance database, after a duplicate check.
This involves an initial triage followed by Data processing and a subsequent medical review by a physician. After the review process, the case reports are submitted to the regulatory authorities/business partners.
HySynth’s people have extensive experience across all case types and have worked with all commercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace and proprietary client databases.
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Presentation: Data Integrity – an international regulatory perspectiveTGA Australia
This presentation will provide an overview of the international regulatory perspective on data integrity and discuss some of the key points highlighted in recently released guidance documents from across the globe.
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
The IDMP Challenge - Whitepaper on ISO IDMP by CunesoftV E R A
The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
Inspiration Lookbook for Financial Servicescolletteseline
We’ve compiled a list of groundbreaking direct mail
campaigns that utilize a cross-channel approach at
different lifecycle stages, all within the financial services space.
Take a look and get inspired.
BizViz is a unique BI platform that was built to give users better knowledge and insight into their business. It enables users to assemble data from multiple structured, semi-structured, and unstructured data sources.
BizViz helps analysts provide Descriptive, Diagnostic, Predictive, and Prescriptive analytics in the cloud, on mobile devices, and on-premise. The BizViz platform intersects SMAC (Social Media, Mobility, Analytics, and Cloud). Users can build and interact with dynamic, information-rich dashboards from any device and will be able to enter real-time data from mobile devices.
Are we burying our heads in the sand? Exploring issues around intellectual pr...Jennifer Cham
The threat of patent infringement to businesses is perhaps better known in industries such as pharmaceuticals, engineering and manufacturing. However, in the User Experience (UX) field there are potential issues around patent infringement that, as practitioners, we need to be aware of. This session (originally a discussion held at UX Cambridge 2014) aimed to increase awareness and start a discussion amongst UX professionals regarding intellectual property issues that may impact our work.
The session was an open discussion, where participants shared their experiences and concerns and posed questions for further exploration. The outcome was a sketchnote (https://www.flickr.com/photos/97823772@N02/15058945187/in/set-72157647610886191) which summarised the discussion. This was created by Chris Spalton, https://twitter.com/ChrisSpalton)
[Please note: we are not intellectual property legal experts. Examples are from our own experience in this area, and secondary research sources. The main aim was to start a conversation and to identify the gaps in our knowledge in this potentially important area.]
Presentation (Slide Share) on Mobile Application Development Services and Why We Need It?. Created by a leading enterprise mobile application development company India, which are offering custom mobile app development services across various platforms like iPhone, Windows, Android, Blackberry and iPad.
Case study 7 chapter 141. 2. Answer the Case Study Questions (.docxwendolynhalbert
Case study 7 chapter 14
1.
2. Answer the Case Study Questions (found at the end of each case study) in 500-750 words total (not including reference list).
3. Include at least one additional, external reference to sources such as an article or video. Cite the reference(s) in your study.
Your case study will be graded on the following:
Grading: 20 points
Content 80% (how thoroughly and logically you answer the questions, how well you incorporate your reference(s), how well you make arguments and state facts to support your answers).
Spelling/Grammar/Punctuation 20%
14-4 What are the principal risk factors in information systems projects, and how can they be managed?
We have already introduced the topic of information system risks and risk assessment in Chapter 8. In this chapter, we describe the specific risks to information systems projects and show what can be done to manage them effectively.Dimensions of Project Risk
Systems differ dramatically in their size, scope, level of complexity, and organizational and technical components. Some systems development projects are more likely to create the problems we have described earlier or to suffer delays because they carry a much higher level of risk than others. The level of project risk is influenced by project size, project structure, and the level of technical expertise of the information systems staff and project team.
· Project size. The larger the project—as indicated by the dollars spent, the size of the implementation staff, the time allocated for implementation, and the number of organizational units affected—the greater the risk. Very large-scale systems projects have a failure rate that is 50 to 75 percent higher than that for other projects because such projects are complex and difficult to control. The organizational complexity of the system—how many units and groups use it and how much it influences business processes—contributes to the complexity of large-scale systems projects just as much as technical characteristics, such as the number of lines of program code, length of project, and budget. In addition, there are few reliable techniques for estimating the time and cost to develop large-scale information systems.
· Project structure. Some projects are more highly structured than others. Their requirements are clear and straightforward, so outputs and processes can be easily defined. Users know exactly what they want and what the system should do; there is almost no possibility of the users changing their minds. Such projects run a much lower risk than those with relatively undefined, fluid, and constantly changing requirements; with outputs that cannot be fixed easily because they are subject to users’ changing ideas; or with users who cannot agree on what they want.
· Experience with technology. The project risk rises if the project team and the information system staff lack the required technical expertise. If the team is unfamiliar with the hardware, system software, applica ...
Hospital management system project report.pdfKamal Acharya
The project Hospital Management system includes registration of patients, storing their details into the system, and also computerized billing in the pharmacy, and labs. The software has the facility to give a unique id for every patient and stores the details of every patient and the staff automatically. It includes a search facility to know the current status of each room. User can search availability of a doctor and the details of a patient using the id. The Hospital Management System can be entered using a username and password. It is accessible either by an administrator or receptionist. Only they can add data into the database. The data can be retrieved easily. The interface is very user-friendly. The data are well protected for personal use and makes the data processing very fast. Hospital Management System is powerful, flexible, and easy to use and is designed and developed to deliver real conceivable benefits to hospitals. Hospital Management System is designed for multispecialty hospitals, to cover a wide range of hospital administration and management processes. It is an integrated end-to-end Hospital Management System that provides relevant information across the hospital to support effective decision making for patient care, hospital administration and critical financial accounting, in a seamless flow. Hospital Management System is a software product suite designed to improve the quality and management of hospital management in the areas of clinical process analysis and activity-based costing. Hospital Management System enables you to develop your organization and improve its effectiveness and quality of work. Managing the key processes efficiently is critical to the success of the hospital helps you manage your processes.
NASSCOM CoE IoT spearheaded a high-level industry roundtable to discuss firsthand the challenges & opportunities in India’s clinical trial industry and how technology can accelerate development
1Running Head Research Paper Final Draft6Research Paper.docxaulasnilda
1
Running Head: Research Paper Final Draft
6
Research Paper Final Draft
Research Paper Final Draft
Himaswetha Polavarapu
Dr.Mary Cecil
University Of The Cumberlands
Information Governance
12/01/2019
ABSTRACT
One of major issues in todays hospitals is period for which medical records are to be retained. Therefore health information managements professionals have traditionally performed record retention and also the destruction functions using media, including the paper, images, the optical disk, microfilm, the DVD, and also CD-ROM. Health information managements departments therefore has to maintain specific program in order to retain and also destruct records. The main purpose of this paper to investigate and maintain the retention and also destruction process of the medical records in hospitals and codifying appropriate guidelines. The research is conducted as cross-sectional descriptive study in hospitals in India. Data was collected using the Check List. Viewpoints to be obtained using Delphi technique. Data entry and also the statistical analysis are performed using the SPSS.
INTRODUCTION
Due to many practices and services offered to people in healthcare that cater to the basic needs of an individual, the company undergoes a series of changes in record overtime which are retained safely to avoid them landing into unauthorized hands because some documents may be carrying sensitive information about individuals. Record retention involves storing records that are not in use anymore for example marriage certificates. Because of this need, different companies have developed an online policy of record detention that will determine how long should these records be retained and provide a disposal guideline. In my research, I will analyze online policies developed by the Healthcare industry on the management of their record retention.
BACKGROUND
Record retention is a very important step initiated in healthcare to ensure there is continuity of care for a patient. Professionals traditionally have been maintaining records through different means like using media as well as paper from which it can be retrieved when the owner visits the healthcare unit again thus can be used for time reference. The management has established an online policy through an appropriate retention schedule which will ensure there is minimal or no legal discovery of the records detained, this approach has worked positively in many organizations including the healthcare sector. Advancement to an online system of record retention through technology has improved the management of this process where data can be retrieved from the system for a specific person very fast and securely according to (Kruse.et.al.2015).
LITERATURE REVIEW
Retention Policies
In the healthcare system, management of records involves some basic steps from creation to utilization to maintenance then finally to retention. The following guidelines are responsible for the development, managem ...
Assignment 1 Legal Aspects of U.S. Health Care System Administrat.docxbraycarissa250
Assignment 1: Legal Aspects of U.S. Health Care System Administration
Due Week 3 and worth 200 points
Prevailing wisdom reinforces the fact that working in U.S. health care administration in the 21st Century requires knowledge of the various aspects of health laws as they apply to dealing with medical professionals. Further, because U.S. health care administrators must potentially interact with many levels of professionals beyond the medical profession, it is prudent that they be aware of any federal, state, and local laws that may be applicable to their organizations. Thus, their conduct is also subject to the letter of the law. They must evaluate the quality of their professional interactions and be mindful of the implications and ramifications of their decisions.
Nearly 65 million surgical operations were performed in 2015 in the U.S. resulting in an estimated 200,000 deaths from complications or other post-operative issues (Ghaferi, Myers, Sutcliffe, & Pronovost, 2016). Ongoing innovation in healthcare can improve patient outcomes. According to the Harvard Business Review article, The Next Wave of Hospital Innovation to Make Patients Safer, over the past several decades, there have been three distinct waves of surgical improvement: technical advancements, standardizing procedures, and high reliability organizing.
Assume the role of a top health administrator at We Care Hospital. You are interested in propelling the hospital to the next level by applying for the Malcolm Baldrige National Quality Award. However, you want to ensure surgical outcomes for patient morbidity and mortality rates. You begin by researching the Surgical Care Improvement Project (SCIP) aimed to improve adherence to quality protocols. You need to ensure the hospital policy is consistent with the law and that the hospital is correctly reporting Sentinel Events to the Joint Commission, a hospital regulatory agency.
Note: You may create and / or make all necessary assumptions needed for the completion of this assignment.
Write a three to four (3-4) page paper in which you:
1. Analyze how standardizing procedures and documenting steps can improve outcomes when performing a complex procedure. Review the peer-reviewed journal article, The Next Wave of Hospital Innovation to Make Patients Safer. Articulate your position as the top administrator concerned about the importance of professional conduct and negligence in SCIP quality guidelines.
2. High Reliability Organizing emphasizes the varying actions that can affect patient safety given that standardized systems ignore the fact that each patient is different. Ascertain the major ramifications when the health care team “fails to rescue” the patient. Identify what hospital policies should be in place and identify previous case laws.
3. Analyze the four (4) elements required of a plaintiff to prove medical negligence.
4. Discuss the overarching duties of the health care governing board in mitigating the effects of medical non- ...
1Milestone 1Deanna BuchananSouthern New Hampshpearlenehodge
1
Milestone 1
Deanna Buchanan
Southern New Hampshire University
HIM-500-Q1513
Milestone 1
In the field of health informatics, particular historical events help inform the management of health information:
1. The 1950s saw the early development of health informatics through cybernetics and information processing. This entailed professionals from various fields, such as clinical documentation and epidemiology.
2. The 1960 to 2000 period saw the evolution of data analysis and computing. Health information management was facilitated through the development of electronic medical records systems. Such systems are vital for health information management since they provide real-time patient-centered records to authorized users (Collen & Ball, 2018).
3. There is the period from 2000 to the present where stakeholders have moved to digitize healthcare processes such as information sharing, record keeping, and care coordination.
Guidelines
There are several guidelines for technology use that Feather fall could implement in health information management. For starters, the medical staff should get the relevant training required to utilize the technology to facilitate the effective acquisition, analysis, and protection of patient information. Training ensures they can tackle any challenges they may encounter to collect accurate data and analyze it in a way that benefits patients. Additionally, the medical staff needs to ensure that the devices they use are beyond the reach of unauthorized individuals. This is crucial in promoting patient confidentiality/privacy and securing pertinent data does not get into the wrong hands (Ozair et al., 2018). Finally, medical practitioners should provide feedback about their experiences to ensure that the technology they use can be improved in the future.
Standard Technologies
There are various standard technologies used in health information management. For starters, concerning record keeping, some of the traditional EHR technologies include Epic Systems and Meditech. Many institutions use these two systems due to their departmental functionality and extensive usability. RingCentral Video is a standard technology for videoconferencing that facilitates open communication and interactive communications among healthcare providers. Different practitioners can share information and work together in real-time to facilitate effective patient care. Finally, there is the use of Vendor-Neutral Archives (VNAs) and Picture Archiving and Communication Systems (PACS) when it comes to processing and storing the medical images of patients (Sirota-Cohen et al., 2019).
How Roles at Feather fall Interact with Technology
The pertinent roles at Feather fall would interact with technology through a simple but effective communication system that ensures all users can get the most out of the health management technologies on offer. Currently, the staff members have poor training and no means of effe ...
Recent discovered technologies have exposed many new theories and possibilities to improve our standard of living. Medical assistance has been a major research topic in the past, many efforts were put in to simplify the process of following treatment prescriptions. This paper summarizes the work done in developing LoRa driven medical adherence system in order to improve medicine adherence for elderlies. The designed system is composed of two sections; embedded hardware device for the use of patients at home and Web application to manage all patients along with their medicines and keep track of their medicine intake history. LoRa wireless communication technology is used for connecting all embedded devices with a central gateway that manages the network. Hardware and software tests have been conducted and showed great performance in terms of LoRa network range and latency. In short, the proposed system shows promising method of improving medicine adherence.
Similar to Design and Development of Cold Chain Monitoring System (20)
Quality defects in TMT Bars, Possible causes and Potential Solutions.PrashantGoswami42
Maintaining high-quality standards in the production of TMT bars is crucial for ensuring structural integrity in construction. Addressing common defects through careful monitoring, standardized processes, and advanced technology can significantly improve the quality of TMT bars. Continuous training and adherence to quality control measures will also play a pivotal role in minimizing these defects.
Forklift Classes Overview by Intella PartsIntella Parts
Discover the different forklift classes and their specific applications. Learn how to choose the right forklift for your needs to ensure safety, efficiency, and compliance in your operations.
For more technical information, visit our website https://intellaparts.com
Industrial Training at Shahjalal Fertilizer Company Limited (SFCL)MdTanvirMahtab2
This presentation is about the working procedure of Shahjalal Fertilizer Company Limited (SFCL). A Govt. owned Company of Bangladesh Chemical Industries Corporation under Ministry of Industries.
Vaccine management system project report documentation..pdfKamal Acharya
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Welcome to WIPAC Monthly the magazine brought to you by the LinkedIn Group Water Industry Process Automation & Control.
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Hybrid optimization of pumped hydro system and solar- Engr. Abdul-Azeez.pdffxintegritypublishin
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Design and Development of Cold Chain Monitoring System
1. 1
Design and Development of Cold Chain Monitoring System
Han-Jung Chen
Department of Industrial Engineering and Management
National Taipei University of Technology
Taipei, Taiwan
Fortunate0810@gami.com
Kai-Ying Chen
Department of Industrial Engineering and Management
National Taipei University of Technology
Taipei, Taiwan
Kychen@ntut.edu.tw
Lih-Guong Jang
Service Systems Technology Center
Industrial Technology Research Institute
Hsinchu, Taiwan
Lihguong@itri.org.tw
Teh-Chang Wu
Service Systems Technology Center
Industrial Technology Research Institute
Hsinchu, Taiwan
Tehchangwu@itri.org.tw
Zhi-Ping Lin
Department of Industrial Engineering and Management
National Taipei University of Technology
Taipei, Taiwan
Cplin@ntut.edu.tw
Abstract—Vaccines must be included into the cold chain
management in order to ensure the safety and maintenance of
a constant low temperature from the origin to the final usage.
Under technological advancements, the safety of vaccines has
been greatly improved during the enhanced manufacturing
process. However, it has been frequently reported in the news
that vaccines, which are intended to save lives, harm the
public’s health due to negligence in management. Mild
negligence may lead to the experience of discomfort, as well as
ineffective vaccines, while severe negligence may lead to a loss
of life. Therefore, it is necessary to strictly manage the
transport, storage, and use of vaccines. This study intends to
design a vaccine cold chain monitoring system (CCMS),
specifically for the two keys in the cold chain, namely
monitoring and temperature, in order to ensure that the
management chain is perfectly connected through information
conveyance and sharing among various roles. Moreover, the
system aims to prevent “unnoticed vaccine failure” through
constant temperature recording. The overall vaccine cold chain
system should be able to ensure the safety of vaccines through
monitoring, tracking, and timely reporting of vaccine safety
under various variables caused by natural disasters and
epidemics.
Keywords-cold chain; vaccine; temperature monitoring
I. INTRODUCTION
Globalization leads to frequent cross-boundary
exchanges, which leads to more frequent transmission and
spread of epidemic diseases. To prevent this situation, the
government in Taiwan has engaged in various disease
prevention programs. The crisis of rapidly spread diseases is
unforgettable for the Taiwanese. The outbreak of SARS
(Severe Acute Respiratory Syndrome (SARS) in 2002 and
the outbreak of Influenza A virus subtype H1N1 (H1N1) in
2009 both endangered the lives of the Taiwanese. The
competent health authorities also started to engage in the
R&D of vaccines and relevant disease prevention
engineering. However, the implementation of vaccination by
health authorities accidentally led to the death of several
people, and the public started to question the safety of
vaccines. Negligence of temperature control during the
transport process can lead to ineffective vaccines; therefore,
low temperature control of vaccines becomes an issue of
great importance for competent health authorities. Clearly
explain the nature of the problem, previous work, purpose,
and contribution of the paper.
Vaccines are not general commodities, but are medical
products affecting the health and safety of the public.
Consequently, it is necessary to strictly monitor the overall
transport, storage, and injection processes of vaccines. The
ineffectiveness of vaccines is usually caused by negligent
maintenance of low temperature control during the transport
process. The injection of ineffective vaccines will do harm to
the patients. A mild effect is discomfort and ineffectiveness,
while a severe effect is the loss of life. Therefore, the World
Health Organization (WHO) announced the “Guidelines on
the International Packaging and Shipping of Vaccines” in
2005, which stipulates the temperature range and effective
period of vaccines during shipping. SOPs and operating
regulations for transport, storage, and injection of vaccines
2. 2
were also established. The “Guidelines on the International
Packaging and Shipping of Vaccines ” also classified
vaccines according to their properties, types, and in vivo
characteristics. The regulations regarding the transport and
storage of vaccines varies with differences in classification
[1].
By reviewing related reports, as well as laws and
regulations of different countries, this study found that the
issue of the cold chain has begun to attract attention both
domestically and overseas. The “chain” actions have been
initiated from refrigeration of food to professional medical
refrigeration [2][3]. For example, the government of the
Netherlands established laws to restrict temperatures for
shipping medicines. GlaxoSmithKline (GSK) developed
complete regulations for their internal cold chain in
accordance with the laws of the government, and further
became a model of the European pharmaceutical cold chain.
Although applicable laws and regulations, or relevant
organizations, have not been established in Taiwan, the ITRI
(Industrial Technology Research Institute) has cooperated
with China to establish the Cross-strait Cold Chain Logistics
Technology and Services Alliance. The government in
Taiwan has initiated the development of a cold chain, and
with experts and various pioneering technologies in Taiwan,
it is believed that the development of the cold chain will
achieve great results and make breakthroughs.
This study intends to establish the traceability of vaccines.
Besides the regular vaccination periods, the use of vaccines
reaches the peak in times of natural disasters and epidemic
outbreaks. Chaotic management and control, as well as a
lack of resources, are challenges to the traceability of
vaccines. Compared with agricultural products, which have
stable traceability, the difficulty and urgency of vaccine
traceability are issues to be addressed [4][5].
II. ARCHITECTURE AND FUNCTIONS
The objective of a vaccine cold chain monitoring system
is to ensure the safety of vaccines through constant low
temperature monitoring and control. The members involved
in the vaccine cold chain can be divided into supplier,
manufacturer, logistics provider, and medical units. However,
at present, enterprises can only request the integration of
internal information systems, and it is impossible for them to
cooperate with all members involved to complete the
integration or elevate the information level to the same level.
This study designed a system that allows the members of the
cold chain to directly upload the information of vaccine cold
chain procedures to a webpage and input the data into the
system; thus, all members could assess the system if they can
access the Internet, regardless of their information capacity
and resources. The data input into the system are the basic
information of products, relevant requirements and planning,
and essential control data. Moreover, the system has to avoid
excessive information integration, which may reduce
enterprises’ willingness or lead to information errors. This
monitoring system can better manage and control the vaccine
cold chain, and is expected to contribute to the future
synergistic integration of cold chain-related industries.
The system structure of this study classifies the authority
limits of various roles, and strictly abides by the regulatory
restrictions of various communications protocols. Regarding
follow-up and reporting functions, they are established
according to similar hazard handling operating formats in
Taiwan. Regarding inspection and assessment functions,
they are established based on the imitation of the review of
CCQI (Cold Chain Quality Indicator). After reviewing the
above operating formats, experts confirmed that there is no
violation of rules or inadequacy. The system structure is as
shown in Fig. 1.
The experimental structure is divided into two parts to
provide explanations. Part 1 is to construct a system platform.
ASP.NET 4.0 and C# language are used to design the
vaccine cold chain monitoring system, which allows the
input of all parameters in the process into the vaccine cold
chain monitoring system through communications
technology, thus, facilitating information exchange and
sharing among various roles in the vaccine supply chain, as
well as the query operation of the system. Regarding Part 2,
in a vaccine cold chain monitoring system, the limits of
authority and relationships of various roles must be strictly
defined in order to meet the regulations for the protection of
safety, privacy, and users’ limits of authority in the
information system. In addition, the data collected from
various roles in this system must be properly archived as
reference for future follow-up, inspection, and review. This
study used Microsoft SQL Server 2005 and Microsoft Office
Access 2007 database to handle members’ limits of authority
and archive various data in the system.
Figure 1. System structure of CCMS
The member database recorded the account number and
password of members and set up their identity, such as
supplier, manufacture, etc. The limits of authority vary with
the differences in roles. In this system, many webpages are
only accessible to specific users. For example, the operating
data and requirement data input by the manufacturer are not
accessible for non-data owners to read, copy, or edit.
Therefore, corresponding regulations on archiving have to be
3. 3
established for the system. This study established rules of
archiving for each interface of the member database, with
limits of authority and corresponding “Access Not Allowed”
to prevent users from accessing interfaces that are beyond
their roles and limits of authority, which could lead to
information disasters of disclosure of information and
privacy.
This vaccine cold chain monitoring system includes
seven major functions: supplier, manufacturer, logistics
provider, medical unit, follow-up & query, hazard &
emergency handling, and inspection & assessment. Access
control prior to entering into the system could determine
relevant information accessible to users in order to control
limits of authority and avoid unauthorized access. The
supplier module enables suppliers to input the data of raw
materials, including name, source, import date, and serial
numbers of raw materials and relevant raw material
examination documents. The manufacture module enables
the manufacturer to input the data concerning the stock and
product, which includes the serial number of the product and
manufacture quality-related examination documents. The
logistics provider module enables the logistics provider to
input the data of the shipped product and its distribution data.
The logistics provider and the manufacturer could share
information concerning transport planning through the
connection between the chains of requirement data. The
medical unit module enables the medical unit to input the
data of the stock and vaccine. The establishment of medical
unit’s requirement data enables the Center for Disease
Control to distribute vaccines after understanding the
quantity of vaccine required by various medical institutions
and propose their requests to the manufacturer. The follow-
up & query module facilitates follow-up on the location
profile and temperature monitoring data through cold chain
number–based information query. The hazard & emergency
handling module facilitates relevant reporting and
emergency handling in case of any emergency. The system
function is as shown in Fig.2 [3].
III. CCMS DESIGN AND IMPLEMENTAION
Users could log into an interface conforming to their
identities after assignment of their roles according to their
identities. This system could strictly monitor members’
limits of authority according to the role-based entry and
verification. If members choose the wrong identities or
accessed the interfaces that are inaccessible to them, the
warning window of “Access Not Allowed” would show up
to notify them of the violation and request them to proceed to
the appropriate screen. Moreover, regarding violations, such
as the intention to “replicate a specific webpage, copy the
content of a website, or amend the webpage” and direct
linkage to an unverified screen, the system would direct the
user to the warning window to prevent non-specific users
from amending or viewing member data, thus, protecting the
privacy of the system, as shown in Fig. 3. Upon verification
of membership, users could access specific user screens,
where their account number would be displayed in a specific
area. Moreover, users could check their account number for
confirmation or choose to log out from this interface. The
interface included four working contents: establishment of
basic information of members, establishment of relevant data,
query of requirement data, and establishment of requirement
data.
Figure 2. Functions of CCMS
Follow-up & query is one of the important functions of
this system. The establishment of various data of members
through the cold chain enables follow-up and query. On the
webpage of follow-up & query, the first vaccine temperature,
as recorded by various members, is displayed. For the
detailed record form, users can click the “Detailed
temperature record form” on the rightmost column, where all
temperature records of a vaccine, from a certain unit, as well
as the location record, are available. The follow-up and
query function enables users to understand the units
responsible for the various processes of the vaccine, as
shown in Fig. 4.
The hazard and emergency handling module is
established in order to avoid a lack of reporting and
subsequent handling in cases of chain breakages owing to a
specific cause. Therefore, this system requests all members
of the cold chain to record the handling of relevant hazards
and temperatures, even when their operation is affected by
other factors, in order to provide accurate operating
information as reference for future inspection.
4. 4
Figure 3. CCMS main page
IV. SCENARIO
A. Scenario A
Vaccine-related events are frequently reported, such as a
vaccine management disorder in China in June 2005 leading
to public fatalities. The cause of the event was poor
management. Various roles involved the manufacture and
shipping processes of vaccines failed to maintain a low
temperature of raw materials and products in order to gain
huge profits. The vaccine history was not recorded, the
temperature record was not maintained,, and a similar review
of cold chain performance was not conducted. The scenario
hypothesized that the code chain number was “CCL020” –
marketing of a vaccine without systemic review. In this
situation, various roles would receive “false vaccines”,
which data were not input into the system. They could not
convey relevant information, thus, the vaccine cold chain
system underwent the examination of the national vaccine-
related authority, where the submission of test reports was
required. Therefore, the unapproved vaccines were
intercepted and tested by disease control authority and the
Bureau of Food and Drug Analysis. If any deficiency had
been found in a vaccine through cold chain monitoring, the
history of vaccine could be followed-up through a review of
the data input into the system by various members during
their operations. The vaccine could then have been recalled
and the cause for the deficiency could be rapidly determined,
as shown in Fig. 5.
Figure 4. CCMS temperature monitoring page
B. Scenario B
This scenario hypothesized hazard handling required by a
changing temperature in this cold chain and the follow-up of
the temperature history of a denatured vaccine. When an
error of a changing temperature occurs, it is necessary to
determine the difference between the time when the error is
found and the time it is reported, according to scientific
measurement. It is also necessary to record the hazard
according to the facts and submit the complete data of
temperature measurement as reference for subsequent hazard
inspection of the vaccine. Moreover, a crisis should be
concurrently managed, such as information conveyance to
the next unit, reporting to a higher-level unit, and notification
of relevant contact persons. If an ineffective vaccine is found,
the history of vaccine temperature can be rapidly followed-
up in order to determine the cause for loss of control over
temperature.
5. 5
Figure 5. CCMS temperature monitoring page
Based on the simulation experiments of scenarios A and
B, the system established for vaccine safety in this study can
ensure the safety of the vaccine. In addition, it can improve
the handling of a crisis, and involved members will no longer
expect their orders. In brief, this system can control the
members of a supply chain and establish a connection
between them. Members can share information with one
another and convey information to implement a follow-up on
a vaccine. In the case of hazard, the cause can be rapidly
determined. As all members of a cold chain have passed
review and inspection, they can better trust one another and
undertake fewer risks. The monitoring of temperature,
management of process records, and the strict management
and review for members all render this study beneficial to
relevant future studies and the improvement of safety and
quality of vaccine for people in Taiwan, where a cold chain
monitoring system will be fully implemented.
V. CONCLUDING REMARKS
Because vaccine-related safety events are constantly
reported, various countries and Taiwan have attached
importance to the issue of vaccine safety. Therefore, this
study developed a vaccine cold chain monitoring system for
follow-up of the cause and temperature records of
ineffective vaccines and the legal control of vaccines. This
study also established an emergency reporting system to
avoid failures of software/hardware, as well as to prevent
information stagnation from endangering vaccine safety.
Moreover, the establishment of a cold chain also enables
mutual information conveyance and sharing among
members, which significantly improves the overall
competitiveness and efficiency of organization. A cold
chain monitoring system has not been fully implemented in
Taiwan, and there are few studies and relevant operating
data regarding cold chains. The establishment of a cold
chain for products sensitive to temperature can ensure the
safety and operating efficiency of products. This study
established a vaccine cold monitoring system for Taiwan,
according to regulatory literature and information of cold
chains from advanced countries in Europe and North
America. The purpose of this study was to collect and
summarize the data provided by various roles/members,
present them on a system platform, and provide complete
vaccine history information to the government, cooperative
members, and medical units.
In summary, the contributions of this study are as
follows:
1. Members of the cold chain can immediately engage
in their operations through mutual information
connections. Vaccine information becomes transparent
through information conveyance, which enables
concerned users of vaccine-related processes to conduct
a thorough inspection through the system.
2. If the vaccine becomes ineffective or if there is any
error made, relevant units can effectively and rapidly
determine the cause through the follow-up & query
function. This function ensures the efficiency of the
subsequent handling of the product, as well as a recall,
should it be necessary.
3. The hazard & emergency reporting function
facilitates effective recording, hazard handling, and
reporting to higher-level units in the case of any
software/hardware malfunction within the cold chain,
thus, hazard situations become transparent and avoid
harm to humans caused by the injection of an ineffective
vaccine.
4. The strict restrictions on limits of authority of
members increase cold chain members’ confidence in
the system’s protection of privacy.
5. The detailed recording of temperature improves
cold chain members’ temperature management and
increases confidence in the product.
REFERENCES
[1] World Health Organization, ”Guidelines on the international
packaging and shipping of vaccine, ” WHO/IVB/05.23,2005, pp. 1-40.
[2] International Quality & Productivity Center, ”Identifying and
Managing Risks along the Cool Chain, ” 4th International
Symposium on Cool Chain, 2011, pp. 29-31 , Berlin, Germany.
[3] M. Net, E. Trias, A. Navarro, A. Ruiz, P. Diaz, J. R. Fontenla, and M.
Manyalich, “Cold Chain Monitoring During Cold Transportation of
Human Corneas for Transplantation, “ Transplantation Proceedings,
Volume 35, Issue 5, 2003, pp. 2036-2038.
[4] M. P. M. Meuwissen, A. G. J. Velthuis, H. Hogeveen and R. B. M.
Huirn, ”Traceability and Certification in Meat Supply Chains,”
Journalof Agribussiness, Vol. 21, No. 2, 2003, pp. 167-181.
[5] J. Ratcliff and M. Boddington, "Practical Use Of It In Traceability In
Food Value Chains, " IFIP Advances in Information and
Communication Technology, Volume 295, 2009, pp. 2161-2175.