This document discusses data governance and integrity in the pharmaceutical industry. It begins with an overview of data integrity, including definitions of data and how to assure data integrity across the data lifecycle. It then discusses data governance, including how to develop a data governance plan. The plan should consider prevention of data integrity issues and detection of any issues. It should include relevant policies, training, and controls. Finally, it provides tips for implementing a data governance plan in phases with oversight and metrics to track progress.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
This presentation provides guidance on good data and record management practices from the World Health Organization (WHO). It emphasizes that data supporting regulatory decisions must be complete, accurate, legible, contemporaneous, original, and attributable. Senior management should ensure effective data governance programs are in place to manage data integrity risks across the data lifecycle. Quality metrics can help identify risks and opportunities for improvement in data reliability.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
Presentation: Inaugural Industry Forum on Good Manufacturing PracticeTGA Australia
This document summarizes John Skerritt's introductory remarks at an inaugural industry forum on good manufacturing practices (GMP). The key points discussed include:
1) Recent reforms to Australia's medicines and medical devices regulations that will impact GMP, including priority reviews, provisional approvals, and reforms for sunscreens and low-risk goods.
2) Initiatives to assist small and medium enterprises (SMEs) with GMP compliance like training, guidance documents, and signposting to other business support services.
3) Ongoing work to streamline GMP processes like risk-based inspections, international cooperation through programs like PIC/S, and greater reliance on inspections of other
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/
Course Objectives:
How does industry use Metrics?
FDA Challenges and Requirements and Use of Quality Metrics
Complexities of Implementation (Industry Feedback)
What does it all mean?
Key in Risk identification – systematic use of information to identify potential sources of harm (hazards)
referring to the risk question or problem description.
Enables the detection of potential problems as early as possible to plan corrective and preventive
actions
Provides indication that controls are losing effectiveness Important in achieving problem resolution and problem prevention
Another important concept of modern quality systems is the use of trending to examine processes as a whole.
Driving wrong behaviors and unintended consequence
• Establishing excessive or overly complex metrics
Comparing data that is not consistently defined or comparison of single data values
Using metrics as a quality “surrogate”
NNIT is a life sciences IT outsourcing specialist with over 20 years of experience in the industry. They have over 1,400 life sciences specialists managing more than 400 applications. Their services include application management, infrastructure outsourcing, and software-as-a-service solutions. NNIT aims to help life sciences companies ensure regulatory compliance, improve cost efficiency, and focus on core business activities through outsourcing non-core IT functions.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
This presentation provides guidance on good data and record management practices from the World Health Organization (WHO). It emphasizes that data supporting regulatory decisions must be complete, accurate, legible, contemporaneous, original, and attributable. Senior management should ensure effective data governance programs are in place to manage data integrity risks across the data lifecycle. Quality metrics can help identify risks and opportunities for improvement in data reliability.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
Presentation: Inaugural Industry Forum on Good Manufacturing PracticeTGA Australia
This document summarizes John Skerritt's introductory remarks at an inaugural industry forum on good manufacturing practices (GMP). The key points discussed include:
1) Recent reforms to Australia's medicines and medical devices regulations that will impact GMP, including priority reviews, provisional approvals, and reforms for sunscreens and low-risk goods.
2) Initiatives to assist small and medium enterprises (SMEs) with GMP compliance like training, guidance documents, and signposting to other business support services.
3) Ongoing work to streamline GMP processes like risk-based inspections, international cooperation through programs like PIC/S, and greater reliance on inspections of other
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/
Course Objectives:
How does industry use Metrics?
FDA Challenges and Requirements and Use of Quality Metrics
Complexities of Implementation (Industry Feedback)
What does it all mean?
Key in Risk identification – systematic use of information to identify potential sources of harm (hazards)
referring to the risk question or problem description.
Enables the detection of potential problems as early as possible to plan corrective and preventive
actions
Provides indication that controls are losing effectiveness Important in achieving problem resolution and problem prevention
Another important concept of modern quality systems is the use of trending to examine processes as a whole.
Driving wrong behaviors and unintended consequence
• Establishing excessive or overly complex metrics
Comparing data that is not consistently defined or comparison of single data values
Using metrics as a quality “surrogate”
NNIT is a life sciences IT outsourcing specialist with over 20 years of experience in the industry. They have over 1,400 life sciences specialists managing more than 400 applications. Their services include application management, infrastructure outsourcing, and software-as-a-service solutions. NNIT aims to help life sciences companies ensure regulatory compliance, improve cost efficiency, and focus on core business activities through outsourcing non-core IT functions.
At GoodSoft, we help clients in Healthcare, Pharma, and Food manufacturing build intelligently designed digital systems and software.
Not only we provide a strong technical expertise but also a deep understanding of domain, target audience, compliance procedures and regulatory norms, which help us build digital products tailored to the needs of your business.
The technology and software we create are designed to transform sophisticated legacy processes into intelligent systems of future. GoodSoft team develops systems and applications tailored to the specific needs of businesses and organisations, with in-depth understanding of processes, compliance requirements.
Feel free to approach me with any questions.
How to Review, Cleanse, and Transform Clinical Data in Oracle InFormPerficient, Inc.
When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster.
During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.
This document discusses the synergies between regulatory information management (RIM) and identification of medicinal products (IDMP). It argues that RIM and IDMP should be considered together, not separately, as IDMP expands on product data beyond what was traditionally included in RIM. The implementation of IDMP standards will converge various regulatory data initiatives and shape future regulatory submissions that will utilize structured IDMP data instead of documents. RIM systems will benefit from using the IDMP data model to standardize product information captured across systems and sources.
Managing an end to end Pharmacovigilance system from affiliates to regulatory...MyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut explores how technology can help address the challenges facing Pharmacovigilance teams.
He reviews how the latest intake technology can influence end-user experience and effectiveness, as well as internal value & efficiency.
He concludes that a focus on simplifying case intake re-shapes the traditional PV system, enabling Pharma companies to reap significant process and efficiency benefits.
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
Mr. Brian Sterling - Traceability: How to Leverage the Lessons from OthersJohn Blue
Traceability: How to Leverage the Lessons from Others - Mr. Brian Sterling, Founder & President, SCS Consulting, from the 2018 NIAA Annual Conference, Livestock Traceability: Opportunities for Animal Agriculture, plus the Traceability and the Real World Interactive Workshop, April 10 - 12, Denver, CO, USA.
More presentations at https://www.youtube.com/channel/UCeUDeS810OcOfuEYwj1oHKQ
At GoodSoft, we help clients in Healthcare, Pharma, and Food manufacturing build intelligently designed digital systems and software.
Not only we provide a strong technical expertise but also a deep understanding of domain, target audience, compliance procedures and regulatory norms, which help us build digital products tailored to the needs of your business.
The technology and software we create are designed to transform sophisticated legacy processes into intelligent systems of future. GoodSoft team develops systems and applications tailored to the specific needs of businesses and organisations, with in-depth understanding of processes, compliance requirements.
GoodSoft is a software development and IT consulting company founded in 2008 that has evolved to provide end-to-end technology solutions for food, health, and pharma businesses. Their mission is to help companies harness digital technology and speed up innovation through building and integrating software solutions. They have delivered over 40 projects and have 11173 employees with over 10 years of experience in software development. Their services include software development, business process automation, IT consulting, and they have created solutions for healthcare, pharma, and food manufacturers to transform processes and connect departments through intelligent systems.
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory CompliancePerficient, Inc.
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
The document discusses Largo Healthcare's distribution channels, internal operations, and operation organization. It has a central warehouse and uses two primary channels to distribute to hospitals: domestic dealers and international affiliates. Internally, it assembles products manually on an assembly line, packages through a machine, and sterilizes using cobalt radiation. The operation organization is also discussed.
Driving risk management through intelligent intake technologyMyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut presents the case for driving risk management through intelligent intake technology.
Andrew outlines how pharmacovigilance professionals can move from passive to active PV fuelling better decision-making.
This presentations covers:
Pharmacovigilance and risk management challenges
Evolving PV landscape
Addressing the challenges
Reviewing the possible architecture
A glimpse of the technology
Implementation benefits
For more info see: www.mymedsandme.com
This document provides an overview of quality risk management and failure mode and effects analysis (FMEA). It discusses risk as a combination of the probability of harm occurring and the severity of that harm. The quality risk management process includes risk identification, analysis, evaluation, control, and communication. FMEA is presented as a systematic method to identify and prevent product and process problems before they occur. Key aspects of FMEA covered include failure modes, effects, risk priority numbers, and using FMEA to prioritize risks for improvement actions. Scales for rating severity, occurrence, detection, and examples of applying FMEA to a drying process are also presented.
It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient. Today’s distribution network for medicinal products is increasingly complex and involves many players. The revised guidelines, published today, lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.
The revised guidelines introduce the following changes:
the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
suitable documentation which prevents errors from spoken communication;
sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
outsourced activities correctly defined to avoid misunderstandings;
rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products)
Drug Regulations has prepared a presentation summarizing the new GDP requirements for Medicinal Products.
The Value of an Engaged Workforce for the Food IndustryAlchemy Systems
This document discusses the value of an engaged workforce. It notes that 70% of workers are either unengaged or actively disengaged, costing companies between $450-550 billion annually in lost productivity. Common reasons for disengaged employees include lack of training, unclear expectations, inconsistent coaching, and poor work environments. The document provides examples of how companies have increased productivity, quality, and yields by better engaging frontline workers and supervisors through training, communication, feedback and recognition programs.
Healthcare logistics for service improvement and a new understanding of patient flow. Presented by Delia Dent, CSC, at HINZ 2014, 11 November 2014, 11.37am, Marlborough Room
The document discusses gathering supply chain data to improve food safety and brand protection. It notes that QADEX was founded in 2005 and has grown significantly. It provides systems to help food companies efficiently gather specifications and other documents from thousands of supplier sites. The vision is to bring all aspects of quality management together in a single dashboard. Common challenges with current paper-based systems are identified around lack of resources, inconsistent supplier cooperation, and gaps in allergen data. Automated IT solutions are presented as helping to gather, analyze, and validate supplier data while freeing up resources. The business case discusses cost savings and reduced risk of product recalls through better supply chain data management.
Meditech Surgicals produces endoscopic surgical instruments for hospitals. Their supply chain faces issues with new product introductions, poor forecasting leading to high finished goods inventory, and long lead times. Demand is actually quite predictable, as hospital usage is stable and market share changes slowly. To improve, Meditech should recognize stable demand, establish forecast accountability, reduce planning delays, and eliminate bulk inventory through a pull-based assembly system.
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...April Bright
Product launch is not the time to start securing reimbursement for your device. Reimbursement remains a complex process for orthopaedic companies that could be lessened if properly aligned throughout commercialization. Mr. Hunter shares the who, what and when of reimbursement to ensure that you’ve received proper coverage prior to launch.
The document describes Meditech Surgical, a medical device company that produces endoscopic surgical instruments. It discusses Meditech's strategy of aggressively competing with its primary competitor, National Medical Corporation, through new product development and a sales-focused approach. It outlines Meditech's distribution network and internal operations, including assembly, packaging, sterilization, and production planning. It notes problems Meditech faced with new product introductions, forecasting, inventory levels, and customer service. Potential solutions involved centralizing data, focusing on high-demand products, improving service levels and inventory management, and reducing supplier lead times.
This document discusses HIMSS Analytics and its role in providing data and analytics to support healthcare decision-making. HIMSS Analytics collects data from healthcare providers around the world on their use of healthcare information technology. This data is analyzed and used to inform government healthcare policies, reflect trends in the healthcare IT market, and provide a roadmap to drive adoption of these technologies. The document also shows data on increases in adoption of electronic medical records and other technologies in US/Canada between 2011-2014, and lists countries that have achieved the highest stages of healthcare IT adoption according to HIMSS Analytics' framework.
Quick Overview: Pharmaceutical Data IntegrityPeter Dellva
Brief overview of the most important aspects of pharmaceutical data integrity. Slideshare includes pharmaceutical and biopharmaceutical industry key resources.
- The document discusses data integrity, which refers to maintaining accurate and consistent data over its entire lifecycle. This is important for the regulated healthcare industry as quality decisions are based on data.
- The FDA uses the ALCOA criteria (Attributable, Legible, Contemporaneous, Original, Accurate) to define expectations for electronic data. Regulatory agencies now focus heavily on data integrity due to instances of fabricated documents and errors.
- Common data integrity issues found by agencies include non-contemporaneous recording, backdating records, re-running samples until desired results are obtained, and data fabrication. Ensuring data integrity helps prevent regulatory actions like warning letters or import bans against companies.
At GoodSoft, we help clients in Healthcare, Pharma, and Food manufacturing build intelligently designed digital systems and software.
Not only we provide a strong technical expertise but also a deep understanding of domain, target audience, compliance procedures and regulatory norms, which help us build digital products tailored to the needs of your business.
The technology and software we create are designed to transform sophisticated legacy processes into intelligent systems of future. GoodSoft team develops systems and applications tailored to the specific needs of businesses and organisations, with in-depth understanding of processes, compliance requirements.
Feel free to approach me with any questions.
How to Review, Cleanse, and Transform Clinical Data in Oracle InFormPerficient, Inc.
When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster.
During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.
This document discusses the synergies between regulatory information management (RIM) and identification of medicinal products (IDMP). It argues that RIM and IDMP should be considered together, not separately, as IDMP expands on product data beyond what was traditionally included in RIM. The implementation of IDMP standards will converge various regulatory data initiatives and shape future regulatory submissions that will utilize structured IDMP data instead of documents. RIM systems will benefit from using the IDMP data model to standardize product information captured across systems and sources.
Managing an end to end Pharmacovigilance system from affiliates to regulatory...MyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut explores how technology can help address the challenges facing Pharmacovigilance teams.
He reviews how the latest intake technology can influence end-user experience and effectiveness, as well as internal value & efficiency.
He concludes that a focus on simplifying case intake re-shapes the traditional PV system, enabling Pharma companies to reap significant process and efficiency benefits.
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
Mr. Brian Sterling - Traceability: How to Leverage the Lessons from OthersJohn Blue
Traceability: How to Leverage the Lessons from Others - Mr. Brian Sterling, Founder & President, SCS Consulting, from the 2018 NIAA Annual Conference, Livestock Traceability: Opportunities for Animal Agriculture, plus the Traceability and the Real World Interactive Workshop, April 10 - 12, Denver, CO, USA.
More presentations at https://www.youtube.com/channel/UCeUDeS810OcOfuEYwj1oHKQ
At GoodSoft, we help clients in Healthcare, Pharma, and Food manufacturing build intelligently designed digital systems and software.
Not only we provide a strong technical expertise but also a deep understanding of domain, target audience, compliance procedures and regulatory norms, which help us build digital products tailored to the needs of your business.
The technology and software we create are designed to transform sophisticated legacy processes into intelligent systems of future. GoodSoft team develops systems and applications tailored to the specific needs of businesses and organisations, with in-depth understanding of processes, compliance requirements.
GoodSoft is a software development and IT consulting company founded in 2008 that has evolved to provide end-to-end technology solutions for food, health, and pharma businesses. Their mission is to help companies harness digital technology and speed up innovation through building and integrating software solutions. They have delivered over 40 projects and have 11173 employees with over 10 years of experience in software development. Their services include software development, business process automation, IT consulting, and they have created solutions for healthcare, pharma, and food manufacturers to transform processes and connect departments through intelligent systems.
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory CompliancePerficient, Inc.
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
The document discusses Largo Healthcare's distribution channels, internal operations, and operation organization. It has a central warehouse and uses two primary channels to distribute to hospitals: domestic dealers and international affiliates. Internally, it assembles products manually on an assembly line, packages through a machine, and sterilizes using cobalt radiation. The operation organization is also discussed.
Driving risk management through intelligent intake technologyMyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut presents the case for driving risk management through intelligent intake technology.
Andrew outlines how pharmacovigilance professionals can move from passive to active PV fuelling better decision-making.
This presentations covers:
Pharmacovigilance and risk management challenges
Evolving PV landscape
Addressing the challenges
Reviewing the possible architecture
A glimpse of the technology
Implementation benefits
For more info see: www.mymedsandme.com
This document provides an overview of quality risk management and failure mode and effects analysis (FMEA). It discusses risk as a combination of the probability of harm occurring and the severity of that harm. The quality risk management process includes risk identification, analysis, evaluation, control, and communication. FMEA is presented as a systematic method to identify and prevent product and process problems before they occur. Key aspects of FMEA covered include failure modes, effects, risk priority numbers, and using FMEA to prioritize risks for improvement actions. Scales for rating severity, occurrence, detection, and examples of applying FMEA to a drying process are also presented.
It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient. Today’s distribution network for medicinal products is increasingly complex and involves many players. The revised guidelines, published today, lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.
The revised guidelines introduce the following changes:
the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
suitable documentation which prevents errors from spoken communication;
sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
outsourced activities correctly defined to avoid misunderstandings;
rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products)
Drug Regulations has prepared a presentation summarizing the new GDP requirements for Medicinal Products.
The Value of an Engaged Workforce for the Food IndustryAlchemy Systems
This document discusses the value of an engaged workforce. It notes that 70% of workers are either unengaged or actively disengaged, costing companies between $450-550 billion annually in lost productivity. Common reasons for disengaged employees include lack of training, unclear expectations, inconsistent coaching, and poor work environments. The document provides examples of how companies have increased productivity, quality, and yields by better engaging frontline workers and supervisors through training, communication, feedback and recognition programs.
Healthcare logistics for service improvement and a new understanding of patient flow. Presented by Delia Dent, CSC, at HINZ 2014, 11 November 2014, 11.37am, Marlborough Room
The document discusses gathering supply chain data to improve food safety and brand protection. It notes that QADEX was founded in 2005 and has grown significantly. It provides systems to help food companies efficiently gather specifications and other documents from thousands of supplier sites. The vision is to bring all aspects of quality management together in a single dashboard. Common challenges with current paper-based systems are identified around lack of resources, inconsistent supplier cooperation, and gaps in allergen data. Automated IT solutions are presented as helping to gather, analyze, and validate supplier data while freeing up resources. The business case discusses cost savings and reduced risk of product recalls through better supply chain data management.
Meditech Surgicals produces endoscopic surgical instruments for hospitals. Their supply chain faces issues with new product introductions, poor forecasting leading to high finished goods inventory, and long lead times. Demand is actually quite predictable, as hospital usage is stable and market share changes slowly. To improve, Meditech should recognize stable demand, establish forecast accountability, reduce planning delays, and eliminate bulk inventory through a pull-based assembly system.
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...April Bright
Product launch is not the time to start securing reimbursement for your device. Reimbursement remains a complex process for orthopaedic companies that could be lessened if properly aligned throughout commercialization. Mr. Hunter shares the who, what and when of reimbursement to ensure that you’ve received proper coverage prior to launch.
The document describes Meditech Surgical, a medical device company that produces endoscopic surgical instruments. It discusses Meditech's strategy of aggressively competing with its primary competitor, National Medical Corporation, through new product development and a sales-focused approach. It outlines Meditech's distribution network and internal operations, including assembly, packaging, sterilization, and production planning. It notes problems Meditech faced with new product introductions, forecasting, inventory levels, and customer service. Potential solutions involved centralizing data, focusing on high-demand products, improving service levels and inventory management, and reducing supplier lead times.
This document discusses HIMSS Analytics and its role in providing data and analytics to support healthcare decision-making. HIMSS Analytics collects data from healthcare providers around the world on their use of healthcare information technology. This data is analyzed and used to inform government healthcare policies, reflect trends in the healthcare IT market, and provide a roadmap to drive adoption of these technologies. The document also shows data on increases in adoption of electronic medical records and other technologies in US/Canada between 2011-2014, and lists countries that have achieved the highest stages of healthcare IT adoption according to HIMSS Analytics' framework.
Quick Overview: Pharmaceutical Data IntegrityPeter Dellva
Brief overview of the most important aspects of pharmaceutical data integrity. Slideshare includes pharmaceutical and biopharmaceutical industry key resources.
- The document discusses data integrity, which refers to maintaining accurate and consistent data over its entire lifecycle. This is important for the regulated healthcare industry as quality decisions are based on data.
- The FDA uses the ALCOA criteria (Attributable, Legible, Contemporaneous, Original, Accurate) to define expectations for electronic data. Regulatory agencies now focus heavily on data integrity due to instances of fabricated documents and errors.
- Common data integrity issues found by agencies include non-contemporaneous recording, backdating records, re-running samples until desired results are obtained, and data fabrication. Ensuring data integrity helps prevent regulatory actions like warning letters or import bans against companies.
Looking for expertise or support on Data Integrity? Contact us today.
Recently, the pharmaceutical industry has been challenged with the regulatory requirements to provide complete, consistent and accurate data, throughout all GMP regulated processes.
Moreover, during audits the regulatory bodies have observed a level of inconsistency in the application of the predicate rules in GMP processes. This has become a growing concern and has led to a set of new (draft) guidances from different market authorities.
Index:
Data Integrity – Why / What
Data life cycle
Core Data Integrity concepts & building blocks
Short & mid-term actions enabling a focused road to compliance
Responsibly Managing Supply Chain Chemical Compliance in the Decade of Regula...Baytouch Solutions
Presented by Baytouch CEO, Malcolm Pollard, at Chemspec Europe 2014 in Budapest. In this presentation Malcolm examines the challenges facing chemical handling companies in keeping regulatory data up-to-date, accessible and accurate in an era where failing to do so can considerably impact their licence to operate.
TransCelerate Overview - Quality Management System Initiave TransCelerate
TransCelerate BioPharma is a non-profit organization whose mission is to collaborate across the biopharmaceutical industry to identify and implement solutions to improve the delivery of new medicines. The Quality Management System initiative aims to advance quality management across the industry by developing a conceptual framework for clinical quality management systems. The initiative has published several papers outlining its frameworks and tools. Its upcoming milestones include releasing additional tools and publishing additional framework papers on risk management and processes.
FDA News Webinar - Inspection IntelligenceArmin Torres
Developing a Digital Data-Driven Approach to preparing for FDA Inspections. Using Data Analytics to proactively monitor internal and external Quality & Compliance data sources.
FDA News Webinar - Inspection IntelligenceArmin Torres
The document discusses developing an inspection intelligence approach using internal and external data sources. It describes using external sources like regulatory findings and user reports to develop a compliance risk profile, and internal quality metrics from systems like CAPA and design controls to monitor process performance. The intelligence platform would provide a holistic view of factors to measure, baseline, and prioritize for improvement. It also discusses challenges like accessing and standardizing data from different sources, training needs, and demonstrating value to management.
Pharmacovigilance Auditing: Ensuring Data Integrity and ComplianceClinosolIndia
Pharmacovigilance auditing is a crucial process within the pharmaceutical industry that focuses on ensuring data integrity and compliance with regulatory requirements related to drug safety and adverse event reporting. It involves systematic and independent assessments of pharmacovigilance systems, processes, and documentation to verify their accuracy, consistency, and adherence to established standards.
Key Objectives of Pharmacovigilance Auditing:
Data Integrity: Auditing aims to ensure the accuracy, completeness, and reliability of pharmacovigilance data. This includes confirming that adverse event reports are properly collected, documented, and stored, and that data manipulation or unauthorized alterations do not occur.
Regulatory Compliance: Audits help ensure that pharmacovigilance activities are in accordance with applicable regulations and guidelines, such as those set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other relevant health authorities.
Process Validation: Auditing assesses the effectiveness of pharmacovigilance processes, such as signal detection, risk assessment, and benefit-risk analysis. It helps verify that these processes are robust, consistently applied, and appropriately documented.
Quality Management System Evaluation: Auditing evaluates the overall quality management system of a pharmaceutical company, including organizational structure, roles and responsibilities, training programs, and documentation practices related to pharmacovigilance.
Vendor Audits: Companies often outsource certain pharmacovigilance activities to third-party vendors. Auditing these vendors ensures they meet the same high standards for data integrity and regulatory compliance.
Continuous Improvement: Auditing identifies areas for improvement within pharmacovigilance systems and processes. It provides valuable insights that can be used to enhance procedures, address deficiencies, and prevent future issues.
2016-06-08 FDA Inspection Readiness - Mikael Ydemikaelyde
The document discusses preparing for FDA inspections of computer systems and IT infrastructure. It outlines developing an IT compliance plan to ensure control of data, applications, infrastructure, procedures, suppliers, documented evidence, and personnel. The plan should identify any gaps and risks. Organizations should qualify IT systems, validate computerized systems, ensure data integrity, and monitor outsourced processes. Training personnel and periodically reviewing the quality management system are also important for inspection readiness. The speaker emphasizes developing evidence of implementing regulatory requirements to demonstrate control to inspectors.
Presentation: An Update on post-market regulatory requirementsTGA Australia
Along with implementation of expedited medicine registration pathways TGA has undertaken enhancements to its post-market monitoring of medicines, with a focus on assisting sponsors meet their regulatory requirements. TGA's new Pharmacovigilance Inspection Program (PVIP) involves interviewing sponsors and reviewing documents in order to assess sponsors' level of compliance with pharmacovigilance obligations. Work is also ongoing with sponsors to determine how best to confirm risk management plan (RMP) commitments are being met. This presentation will provide further detail on how TGA is working with and assisting sponsors satisfy their regulatory requirements.
A look at benefits realisation during every phase of transformation activities to operationalise portable digital health records
Day Two, Pop-up University 2, 09.00
What is New in Track and Trace Technology?Angela Carver
In the distribution and logistics field track and trace is defined as the process of identifying past and current locations of inventory items. This inventory should be tracked at any level from ingredient to finished product and anywhere in between. Track and trace processes are supported through a variety of SCM technologies that help to provide real-time information on both location and status of these items as they move throughout the supply chain. A focus has been placed on track and trace due to the increasing complexity of governmental regulations. The government is becoming more active due to food recalls reaching their all-time high in 2013. On average, 6 recalls occur in the U.S. each day. These recalls impact up to 18.4 million products including pharmaceuticals, food and much more. This issue has sparked the focus on technology and automation throughout the supply chain.
These technologies are being used to manage the many moving pieces of the supply chain. In order to create a detailed, accurate audit trail needed to satisfy new regulations supply chain operators are implementing a variety of track and trace solutions including WMS, RFID and automated data collection devices.
SCM businesses handling food and pharmaceutical products have started to implement temperature indicators to track temperature, humidity and shock levels throughout the delivery process. These devices come in a variety of designs for flexible use. The data collected using temperature indicators can be transferred directly into inventory management software to develop a complete audit trail.
RFID functions in a similar way, passively tracking inventory as it moves throughout the supply chain. Radio frequency identification also helps to reduce the labor required to handle and process inventory. RFID is useful because it can track inventory at any level through the manufacturing process.
Warehouse management software is also a top tool used by SCM businesses focusing on track and trace because these powerful databases store all captured inventory data making it easily accessible to warehouse operators. Many top WMS systems are also developed to meet government regulations, taking the guess work out of track and trace.
To ensure your operation can meet regulatory requirements consider evaluating these technologies to bridge any gaps in technology capabilities. Learn more about new track and trace functionality and supply chain needs contact Datex experts today at marketing@datexcorp.com or 800.933.2839 ext 243.
Financial Services - New Approach to Data Management in the Digital Eraaccenture
How current is your data management strategy? As technology—and the requirements and business drivers around it—changes, financial services firms will need to change their approach to data management. To guide your approach, see the three building blocks to Accenture’s data management framework covered in this presentation.
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.
Dr. Dan Mingle's Overview of the 2015 Medicare Final RuleMingle Analytics
Dr. Dan Mingle, CEO of Mingle Analytics, reviews the 2015 Medicare Final Rule. Need help avoiding CMS payment adjustments and penalties? PQRS Solutions(TM), software and services by Mingle Analytics(TM), can help. Learn more at http://www.pqrssolutions.com
Tackling the Challanges of Pharma ManufacturingJason Corder
By nature, pharmaceutical manufacturing operations are complex, inefficient, and consequently costly. Due to the inherent complexities, the cost of poor efficiency and its root causes are often not well understood by many manufacturers.
This document discusses data integrity expectations from regulatory agencies like the TGA. It defines data integrity as ensuring data is complete, consistent and accurate throughout its lifecycle. Recent global cases of data integrity issues at drug manufacturers are presented, involving falsification of records, deletion of lab data, and lack of controls around electronic data changes. The ALCOA principles for attributable, legible, contemporaneous, original and accurate data are described. TGA expectations include manufacturers understanding their vulnerabilities, assessing data integrity risks, designing systems to prevent issues, training staff, and having ongoing review systems. Conclusions state existing quality systems should ensure data integrity and traceability, and manufacturers are responsible for preventing and detecting integrity issues.
State of Artificial intelligence Report 2023kuntobimo2016
Artificial intelligence (AI) is a multidisciplinary field of science and engineering whose goal is to create intelligent machines.
We believe that AI will be a force multiplier on technological progress in our increasingly digital, data-driven world. This is because everything around us today, ranging from culture to consumer products, is a product of intelligence.
The State of AI Report is now in its sixth year. Consider this report as a compilation of the most interesting things we’ve seen with a goal of triggering an informed conversation about the state of AI and its implication for the future.
We consider the following key dimensions in our report:
Research: Technology breakthroughs and their capabilities.
Industry: Areas of commercial application for AI and its business impact.
Politics: Regulation of AI, its economic implications and the evolving geopolitics of AI.
Safety: Identifying and mitigating catastrophic risks that highly-capable future AI systems could pose to us.
Predictions: What we believe will happen in the next 12 months and a 2022 performance review to keep us honest.
06-04-2024 - NYC Tech Week - Discussion on Vector Databases, Unstructured Data and AI
Round table discussion of vector databases, unstructured data, ai, big data, real-time, robots and Milvus.
A lively discussion with NJ Gen AI Meetup Lead, Prasad and Procure.FYI's Co-Found
4th Modern Marketing Reckoner by MMA Global India & Group M: 60+ experts on W...Social Samosa
The Modern Marketing Reckoner (MMR) is a comprehensive resource packed with POVs from 60+ industry leaders on how AI is transforming the 4 key pillars of marketing – product, place, price and promotions.
The Ipsos - AI - Monitor 2024 Report.pdfSocial Samosa
According to Ipsos AI Monitor's 2024 report, 65% Indians said that products and services using AI have profoundly changed their daily life in the past 3-5 years.
End-to-end pipeline agility - Berlin Buzzwords 2024Lars Albertsson
We describe how we achieve high change agility in data engineering by eliminating the fear of breaking downstream data pipelines through end-to-end pipeline testing, and by using schema metaprogramming to safely eliminate boilerplate involved in changes that affect whole pipelines.
A quick poll on agility in changing pipelines from end to end indicated a huge span in capabilities. For the question "How long time does it take for all downstream pipelines to be adapted to an upstream change," the median response was 6 months, but some respondents could do it in less than a day. When quantitative data engineering differences between the best and worst are measured, the span is often 100x-1000x, sometimes even more.
A long time ago, we suffered at Spotify from fear of changing pipelines due to not knowing what the impact might be downstream. We made plans for a technical solution to test pipelines end-to-end to mitigate that fear, but the effort failed for cultural reasons. We eventually solved this challenge, but in a different context. In this presentation we will describe how we test full pipelines effectively by manipulating workflow orchestration, which enables us to make changes in pipelines without fear of breaking downstream.
Making schema changes that affect many jobs also involves a lot of toil and boilerplate. Using schema-on-read mitigates some of it, but has drawbacks since it makes it more difficult to detect errors early. We will describe how we have rejected this tradeoff by applying schema metaprogramming, eliminating boilerplate but keeping the protection of static typing, thereby further improving agility to quickly modify data pipelines without fear.
The Building Blocks of QuestDB, a Time Series Databasejavier ramirez
Talk Delivered at Valencia Codes Meetup 2024-06.
Traditionally, databases have treated timestamps just as another data type. However, when performing real-time analytics, timestamps should be first class citizens and we need rich time semantics to get the most out of our data. We also need to deal with ever growing datasets while keeping performant, which is as fun as it sounds.
It is no wonder time-series databases are now more popular than ever before. Join me in this session to learn about the internal architecture and building blocks of QuestDB, an open source time-series database designed for speed. We will also review a history of some of the changes we have gone over the past two years to deal with late and unordered data, non-blocking writes, read-replicas, or faster batch ingestion.