A leading Biopharmaceuticals organization who are an early innovator of COVID-19 vaccine wanted to achieve an automated process for achieving data integrity and compliance for their manufacturing plant QC and research laboratories.
Continuous Integration and Continuous Delivery on AzureCitiusTech
Healthcare organizations are increasingly turning to cloud computing to address business and patient needs of their rapidly evolving environment and modernize legacy applications. With Azure DevOps, healthcare IT teams can drive innovation, build new products and modernize their application environment.
8 Guiding Principles to Kickstart Your Healthcare Big Data ProjectCitiusTech
This white paper illustrates our experiences and learnings across multiple Big Data implementation projects. It contains a broad set of guidelines and best practices around Big Data management.
SaaS System Validation, practical tips on getting validated for go-live and t...Steffan Stringer
Validation is required for computerized systems used in regulated activities according to regulations like EMA Annex 11 and FDA 21 CFR Part 11. While traditional validation is project-based, agile development uses iterative sprints requiring a different validation approach. When using SaaS, the regulated company performs validation activities while leveraging documentation from the SaaS provider. Both parties should work together throughout product setup and testing to facilitate validation.
This presentation from Shipcom provides an overview of the company and its Catamaran technology. Shipcom's Catamaran platform is a real-time location system and asset management solution that integrates with various commercial and government systems. The presentation discusses how Catamaran can help organizations track assets, manage supply chains and inventory, and gain visibility into healthcare operations and facilities. It also provides a demonstration of Catamaran's capabilities.
Why Are Life Science Companies Moving to Office 365?Montrium
The webinar will cover the following topics:
-Moving away from costly and inefficient legacy systems
-Key GxP features and capabilities available in the cloud
-Case studies of Office 365 across the life sciences landscape
-What comes with a continuous Office 365 Validation Subscription?
-Montrium methodology, tools, and documentation available to you
DevOps & Blockchain: Powering Rapid Software Delivery in Regulated EnvironmentsCognizant
As IT organizations push forward with DevOps tools that automate application development and maintenance processes, they can lose sight of the key “who, what, where and when” variables that surround software releases, thus elevating the possibility of noncompliance with a host of regulatory mandates. By embracing blockchain, they can create a tamper-proof way of ensuring regulatory compliance while extending their embrace of IT service automation.
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Montrium
Want to deploy a new technology solution but not sure where to begin? These slides cover key considerations for choosing a vendor with cloud compliance and validation in mind. With the Office 365 subscription-based service gaining considerable momentum in the life sciences, it's important to stay ahead of the technological and regulatory curve and consider how an EDMS system will bring improvements to managing your GxP content.
Here we cover the following topics:
-Vendor assessment of Microsoft
-Subscription basics of Office 365
-Review of ISO/SOC audit reports
-Ensuring that no critical observations are made
-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
Continuous Integration and Continuous Delivery on AzureCitiusTech
Healthcare organizations are increasingly turning to cloud computing to address business and patient needs of their rapidly evolving environment and modernize legacy applications. With Azure DevOps, healthcare IT teams can drive innovation, build new products and modernize their application environment.
8 Guiding Principles to Kickstart Your Healthcare Big Data ProjectCitiusTech
This white paper illustrates our experiences and learnings across multiple Big Data implementation projects. It contains a broad set of guidelines and best practices around Big Data management.
SaaS System Validation, practical tips on getting validated for go-live and t...Steffan Stringer
Validation is required for computerized systems used in regulated activities according to regulations like EMA Annex 11 and FDA 21 CFR Part 11. While traditional validation is project-based, agile development uses iterative sprints requiring a different validation approach. When using SaaS, the regulated company performs validation activities while leveraging documentation from the SaaS provider. Both parties should work together throughout product setup and testing to facilitate validation.
This presentation from Shipcom provides an overview of the company and its Catamaran technology. Shipcom's Catamaran platform is a real-time location system and asset management solution that integrates with various commercial and government systems. The presentation discusses how Catamaran can help organizations track assets, manage supply chains and inventory, and gain visibility into healthcare operations and facilities. It also provides a demonstration of Catamaran's capabilities.
Why Are Life Science Companies Moving to Office 365?Montrium
The webinar will cover the following topics:
-Moving away from costly and inefficient legacy systems
-Key GxP features and capabilities available in the cloud
-Case studies of Office 365 across the life sciences landscape
-What comes with a continuous Office 365 Validation Subscription?
-Montrium methodology, tools, and documentation available to you
DevOps & Blockchain: Powering Rapid Software Delivery in Regulated EnvironmentsCognizant
As IT organizations push forward with DevOps tools that automate application development and maintenance processes, they can lose sight of the key “who, what, where and when” variables that surround software releases, thus elevating the possibility of noncompliance with a host of regulatory mandates. By embracing blockchain, they can create a tamper-proof way of ensuring regulatory compliance while extending their embrace of IT service automation.
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Montrium
Want to deploy a new technology solution but not sure where to begin? These slides cover key considerations for choosing a vendor with cloud compliance and validation in mind. With the Office 365 subscription-based service gaining considerable momentum in the life sciences, it's important to stay ahead of the technological and regulatory curve and consider how an EDMS system will bring improvements to managing your GxP content.
Here we cover the following topics:
-Vendor assessment of Microsoft
-Subscription basics of Office 365
-Review of ISO/SOC audit reports
-Ensuring that no critical observations are made
-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
Analysis of a high availability and data integration solution of an electroni...IvanZennaro
This document discusses three case studies analyzing high availability solutions and data virtualization for an electronics manufacturing company called Telit Communications. The first case study examines implementing high availability for factory web servers. The second analyzes high availability for factory databases. The third evaluates using data virtualization to optimize data management and integration from multiple sources. Real business scenarios and use cases are described, and each proposed technology is tested individually to understand how it can benefit the company.
Microservices: A Step Towards Modernizing Healthcare ApplicationsCitiusTech
This document/White Paper talks about the importance of Microservices and the role that it plays in today's ever-changing IT heathcare landscape.
The document aims to share a perspective on areas to consider while adopting microservices architecture for modernizing healthcare applications.
The document summarizes key FDA regulations and guidance related to electronic records and electronic signatures, including 21 CFR Part 11. It outlines requirements for electronic signatures from regulations like 21 CFR Part 11, Annex 11, and guidance documents from the FDA and EMA. The document emphasizes that these regulations apply to all electronic records, not just those with electronic signatures, and are intended to help catch criminals by ensuring the integrity of electronic records and signatures.
Richard Machanoff is an independent IT consultant who provides "Rent a CIO" services to small and mid-sized companies. He has 25 years of experience in IT leadership roles across various sectors. He can help organizations maximize their investment in IT and assist with FDA 21 CFR part 11 compliance. Part 11 permits electronic records and signatures to be equivalent to paper but sets criteria for systems to ensure accuracy, reliability, and security. Compliance requires measures like system validation, audit logs, backups, access controls, and documented processes for systems and personnel. Computer system validation is a key part of the compliance approach.
Computer validation testing involves verifying that IT and network equipment such as servers, routers, switches, and cabling are installed and operate as intended. The document discusses validation procedures including installation qualification (IQ) to check proper installation, and operational qualification (OQ) testing including hardware diagnostics, startup/shutdown, power loss simulation, and communications redundancy checks for servers. Regulatory compliance and ensuring consistent system performance are the goals of validation.
NERC CIP Version 5 and Beyond – Compliance and the Vendor’s RoleEnergySec
Presenter: Joseph Loomis, Southwest Research Institute (SwRI)
Asset Owners face challenges as they strive towards implementing the NERC-CIP V5 requirements. Meeting the requirements often require documentation and technical knowledge of how an asset operates that can only be provided by a Vendor. Vendors, likewise, may be unclear about how the NERC-CIP requirements affect them, and are unsure about how to meet the technical requirements. In this presentation we detail the lessons learned from a recent project where SwRI worked with a Vendor to determine how the requirements apply to them and what the Vendor needs to have to help support an Asset Owner in an audit.
The document summarizes the services provided by BAT including software engineering, product engineering, testing, domain services for life sciences and healthcare, and engagement models. BAT offers application development, instrument integration, compliance services, method development, data analysis, product development, and sustenance across life sciences, pharma, healthcare, and industrial domains. They utilize technologies like Java, C/C++, embedded systems, and analytics and can engage through time and material, managed projects, or dedicated centers based on project needs.
Explore the Implicit Requirements of the NERC CIP RSAWsEnergySec
Regulated entities should consider the RSAW templates when preparing evidence of compliance with the NERC CIP Standards. There are a number of implicit requirements in CIP v5 which an entity needs to fulfill to be compliant, which are not specifically identified in the actual requirements.
In this webinar, our experts will discuss such implicit requirements. Key learning's from this session would be:
RSAW format
Implicit requirements of CIP RSAWs
Leveraging technology for RSAW management
The North American Electric Reliability Corporation (NERC) introduced Critical Infrastructure Protections (CIPs) as mandatory cyber security regulations, intended to protect the bulk electric grid. This compliance guide, updated according to NERC CIP version 4 (applicable as of June 25, 2012), provides an overview of the compliance requirements as well as steps to achieve NERC compliance.
To download a free Nexpose demo, click here:
http://www.rapid7.com/products/nexpose/compare-downloads.jsp
To download a free Metasploit demo, click here:
http://www.rapid7.com/products/metasploit/download.jsp
Computer System Validation – Reduce Costs and Avoid 483sReferral
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
For More Info:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=slideshare.net
Scott Kirkman is an experienced IT manager with expertise in developing supply chain and distribution applications for the pharmaceutical industry. He has over 15 years of experience managing projects, software development teams, and IT departments. Kirkman has extensive knowledge of regulations and systems for prescription drug distribution, cold chain shipments, and FDA compliance.
From Vision to Implementation: A Complete, Consistent and Compliant eTMFWingspan Technology
Pfizer partnered with Wingspan to develop an electronic Trial Master File (eTMF) system to transform their document management processes. They spent 10 months defining requirements and selected Wingspan based on their capabilities. Wingspan then spent 5 months designing a highly optimized system. The teams worked closely over 12 months to deliver the system, meeting all milestones on time. The new eTMF provides complete, compliant and consistent management of studies and documents for Pfizer's global clinical trials.
#GDPR Compliance - Data Minimization via ArchivePodGaret Keller
The ArchivePod is a hyperconverged appliance that provides a GDPR-compliant solution for archiving data from retired applications. It reduces infrastructure needs and costs while ensuring archived data is securely stored in a centralized, immutable repository. The ArchivePod addresses GDPR requirements such as data subject rights, data minimization, and portability through features like automated workflows, encryption, audit logs, and centralized reporting. It allows customers to achieve GDPR compliance more quickly and easily than building their own solution.
How Logilab SDMS helps Laboratories to enable GLP Compliance - 4Agaram Technologies
GLP lays down a very important principle that the data captured or entered in the system
must be accurate. In order to ensure accuracy, GLP necessitates computerized system
must have the capability to validate, verify and filter the data for accuracy. Logilab SDMS
ensures that users can verify the data that is captured from the instruments can go through
a workflow process. Using the workflow tool users will be guided to follow the review and
approval processes so that data errors can be avoided.
Troika International develops data transcription software and tools to help oil companies manage their seismic data assets in a more automated way. Their suite of interlinked modules provides complete control over SEG formatted data through configurable tools and extraction files. These tools allow users to organize, classify, validate and extract optimum information from seismic data to facilitate data management tasks.
Việc duy trì kiểm soát các điều kiện môi trường trong các phòng thí nghiệm hoặc phòng sạch được quản lý chặt chẽ để tuân thủ các tiêu chuẩn GMP. Tuy nhiên việc này phức tạp và tốn thời gian. Hướng dẫn này đưa ra một số khía cạnh quan trọng cần xem xét để giảm thiểu rủi ro và duy trì sự tuân thủ trong phòng thí nghiệm hoặc phòng sạch.
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
This webinar is focused on the current state of UDI regulations, the best approaches to medical device UDI Compliance in the cloud and how to gain business benefits by implementing KPIT's UDI Cloud Solution. This is a must-watch session for medical device companies who are preparing for UDI compliance or the ones who have already implemented however looking for a long-term solution.
Enterprise SCADA Standardization - Nov 2010 - Digital Oilfield.PDFsmrobb
A SCADA control room operator for a gas producer faces hundreds of alarms daily from over 800 wells, but the alarms have no standard prioritization, making it difficult for the operator to identify and respond to critical issues. A SCADA implementation project by a major oil and gas company partnered a software vendor and automation consultant to standardize alarm management, data tagging, and screen displays across multiple facilities. By building on existing standards within the company for health, safety, and environmental protocols and historian databases, the project resulted in uniform alarm prioritization and data naming across sites in different regions with no downtime.
IND3: Predix for Transportation (Predix Transform 2016)Predix
http://Predixtransform.com
4400 horse-power diesel-electric locomotives also are power houses of advanced software processing, analyzing massive amounts of sensor, operations, video, and even drone data. Join experts from GE Transportations on a journey through Predix powered solutions (the ‘Railroad Operating System') for fuel efficiency, emissions reduction, network velocity, and safety. And look under the hood of two core applications, GoLINC Edge Device Management and the GET Mobility Platform.
Curing dataheadachesv2 with sugarcrm levementum and talendGeoffrey Mobisson
This document discusses integrating Talend and SugarCRM to help cure data headaches. It provides an overview of Talend including its key features and market positioning for data integration. It then discusses in more detail Talend's data integration capabilities and tools. The document presents a customer case study of Estes Inc. which used Talend and SugarCRM along with other open source solutions to modernize its systems. It outlines the key integration use cases enabled between SugarCRM and Compiere through Levementum's connector to provide a consistent customer view across both platforms.
Qualcomm Life Connect 2013: 2net System Overview, Security and PrivacyQualcomm Life
The document provides an overview of the 2net system, including its product overview describing how biometric data flows from devices to the cloud platform, as well as its security and privacy features leveraging Qualcomm's expertise in network operations. Key aspects covered include the 2net hub, cloud platform, and end-to-end data flows, as well as Qualcomm's focus on proactive data protection, cybersecurity initiatives, and use of a premier enterprise wireless data platform.
Analysis of a high availability and data integration solution of an electroni...IvanZennaro
This document discusses three case studies analyzing high availability solutions and data virtualization for an electronics manufacturing company called Telit Communications. The first case study examines implementing high availability for factory web servers. The second analyzes high availability for factory databases. The third evaluates using data virtualization to optimize data management and integration from multiple sources. Real business scenarios and use cases are described, and each proposed technology is tested individually to understand how it can benefit the company.
Microservices: A Step Towards Modernizing Healthcare ApplicationsCitiusTech
This document/White Paper talks about the importance of Microservices and the role that it plays in today's ever-changing IT heathcare landscape.
The document aims to share a perspective on areas to consider while adopting microservices architecture for modernizing healthcare applications.
The document summarizes key FDA regulations and guidance related to electronic records and electronic signatures, including 21 CFR Part 11. It outlines requirements for electronic signatures from regulations like 21 CFR Part 11, Annex 11, and guidance documents from the FDA and EMA. The document emphasizes that these regulations apply to all electronic records, not just those with electronic signatures, and are intended to help catch criminals by ensuring the integrity of electronic records and signatures.
Richard Machanoff is an independent IT consultant who provides "Rent a CIO" services to small and mid-sized companies. He has 25 years of experience in IT leadership roles across various sectors. He can help organizations maximize their investment in IT and assist with FDA 21 CFR part 11 compliance. Part 11 permits electronic records and signatures to be equivalent to paper but sets criteria for systems to ensure accuracy, reliability, and security. Compliance requires measures like system validation, audit logs, backups, access controls, and documented processes for systems and personnel. Computer system validation is a key part of the compliance approach.
Computer validation testing involves verifying that IT and network equipment such as servers, routers, switches, and cabling are installed and operate as intended. The document discusses validation procedures including installation qualification (IQ) to check proper installation, and operational qualification (OQ) testing including hardware diagnostics, startup/shutdown, power loss simulation, and communications redundancy checks for servers. Regulatory compliance and ensuring consistent system performance are the goals of validation.
NERC CIP Version 5 and Beyond – Compliance and the Vendor’s RoleEnergySec
Presenter: Joseph Loomis, Southwest Research Institute (SwRI)
Asset Owners face challenges as they strive towards implementing the NERC-CIP V5 requirements. Meeting the requirements often require documentation and technical knowledge of how an asset operates that can only be provided by a Vendor. Vendors, likewise, may be unclear about how the NERC-CIP requirements affect them, and are unsure about how to meet the technical requirements. In this presentation we detail the lessons learned from a recent project where SwRI worked with a Vendor to determine how the requirements apply to them and what the Vendor needs to have to help support an Asset Owner in an audit.
The document summarizes the services provided by BAT including software engineering, product engineering, testing, domain services for life sciences and healthcare, and engagement models. BAT offers application development, instrument integration, compliance services, method development, data analysis, product development, and sustenance across life sciences, pharma, healthcare, and industrial domains. They utilize technologies like Java, C/C++, embedded systems, and analytics and can engage through time and material, managed projects, or dedicated centers based on project needs.
Explore the Implicit Requirements of the NERC CIP RSAWsEnergySec
Regulated entities should consider the RSAW templates when preparing evidence of compliance with the NERC CIP Standards. There are a number of implicit requirements in CIP v5 which an entity needs to fulfill to be compliant, which are not specifically identified in the actual requirements.
In this webinar, our experts will discuss such implicit requirements. Key learning's from this session would be:
RSAW format
Implicit requirements of CIP RSAWs
Leveraging technology for RSAW management
The North American Electric Reliability Corporation (NERC) introduced Critical Infrastructure Protections (CIPs) as mandatory cyber security regulations, intended to protect the bulk electric grid. This compliance guide, updated according to NERC CIP version 4 (applicable as of June 25, 2012), provides an overview of the compliance requirements as well as steps to achieve NERC compliance.
To download a free Nexpose demo, click here:
http://www.rapid7.com/products/nexpose/compare-downloads.jsp
To download a free Metasploit demo, click here:
http://www.rapid7.com/products/metasploit/download.jsp
Computer System Validation – Reduce Costs and Avoid 483sReferral
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
For More Info:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=slideshare.net
Scott Kirkman is an experienced IT manager with expertise in developing supply chain and distribution applications for the pharmaceutical industry. He has over 15 years of experience managing projects, software development teams, and IT departments. Kirkman has extensive knowledge of regulations and systems for prescription drug distribution, cold chain shipments, and FDA compliance.
From Vision to Implementation: A Complete, Consistent and Compliant eTMFWingspan Technology
Pfizer partnered with Wingspan to develop an electronic Trial Master File (eTMF) system to transform their document management processes. They spent 10 months defining requirements and selected Wingspan based on their capabilities. Wingspan then spent 5 months designing a highly optimized system. The teams worked closely over 12 months to deliver the system, meeting all milestones on time. The new eTMF provides complete, compliant and consistent management of studies and documents for Pfizer's global clinical trials.
#GDPR Compliance - Data Minimization via ArchivePodGaret Keller
The ArchivePod is a hyperconverged appliance that provides a GDPR-compliant solution for archiving data from retired applications. It reduces infrastructure needs and costs while ensuring archived data is securely stored in a centralized, immutable repository. The ArchivePod addresses GDPR requirements such as data subject rights, data minimization, and portability through features like automated workflows, encryption, audit logs, and centralized reporting. It allows customers to achieve GDPR compliance more quickly and easily than building their own solution.
How Logilab SDMS helps Laboratories to enable GLP Compliance - 4Agaram Technologies
GLP lays down a very important principle that the data captured or entered in the system
must be accurate. In order to ensure accuracy, GLP necessitates computerized system
must have the capability to validate, verify and filter the data for accuracy. Logilab SDMS
ensures that users can verify the data that is captured from the instruments can go through
a workflow process. Using the workflow tool users will be guided to follow the review and
approval processes so that data errors can be avoided.
Troika International develops data transcription software and tools to help oil companies manage their seismic data assets in a more automated way. Their suite of interlinked modules provides complete control over SEG formatted data through configurable tools and extraction files. These tools allow users to organize, classify, validate and extract optimum information from seismic data to facilitate data management tasks.
Việc duy trì kiểm soát các điều kiện môi trường trong các phòng thí nghiệm hoặc phòng sạch được quản lý chặt chẽ để tuân thủ các tiêu chuẩn GMP. Tuy nhiên việc này phức tạp và tốn thời gian. Hướng dẫn này đưa ra một số khía cạnh quan trọng cần xem xét để giảm thiểu rủi ro và duy trì sự tuân thủ trong phòng thí nghiệm hoặc phòng sạch.
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
This webinar is focused on the current state of UDI regulations, the best approaches to medical device UDI Compliance in the cloud and how to gain business benefits by implementing KPIT's UDI Cloud Solution. This is a must-watch session for medical device companies who are preparing for UDI compliance or the ones who have already implemented however looking for a long-term solution.
Enterprise SCADA Standardization - Nov 2010 - Digital Oilfield.PDFsmrobb
A SCADA control room operator for a gas producer faces hundreds of alarms daily from over 800 wells, but the alarms have no standard prioritization, making it difficult for the operator to identify and respond to critical issues. A SCADA implementation project by a major oil and gas company partnered a software vendor and automation consultant to standardize alarm management, data tagging, and screen displays across multiple facilities. By building on existing standards within the company for health, safety, and environmental protocols and historian databases, the project resulted in uniform alarm prioritization and data naming across sites in different regions with no downtime.
IND3: Predix for Transportation (Predix Transform 2016)Predix
http://Predixtransform.com
4400 horse-power diesel-electric locomotives also are power houses of advanced software processing, analyzing massive amounts of sensor, operations, video, and even drone data. Join experts from GE Transportations on a journey through Predix powered solutions (the ‘Railroad Operating System') for fuel efficiency, emissions reduction, network velocity, and safety. And look under the hood of two core applications, GoLINC Edge Device Management and the GET Mobility Platform.
Curing dataheadachesv2 with sugarcrm levementum and talendGeoffrey Mobisson
This document discusses integrating Talend and SugarCRM to help cure data headaches. It provides an overview of Talend including its key features and market positioning for data integration. It then discusses in more detail Talend's data integration capabilities and tools. The document presents a customer case study of Estes Inc. which used Talend and SugarCRM along with other open source solutions to modernize its systems. It outlines the key integration use cases enabled between SugarCRM and Compiere through Levementum's connector to provide a consistent customer view across both platforms.
Qualcomm Life Connect 2013: 2net System Overview, Security and PrivacyQualcomm Life
The document provides an overview of the 2net system, including its product overview describing how biometric data flows from devices to the cloud platform, as well as its security and privacy features leveraging Qualcomm's expertise in network operations. Key aspects covered include the 2net hub, cloud platform, and end-to-end data flows, as well as Qualcomm's focus on proactive data protection, cybersecurity initiatives, and use of a premier enterprise wireless data platform.
Today’s research projects are often carried out across collaborative networks of pharma’s, biotech’s, CRO’S and
Academics in a variety of arrangements from fee-for-service to joint IP discovery to large consortia.
The Dotmatics
informatics solution for collaborative network research can help ensure the success of all these arrangements,
allowing real-time scientific data exchange, enhanced communication, project management and even shared
scientific decision making across all partners.
We have 15 years of experience working with CROs to support collaborative data management platforms. Many of our
customers had significant problems in working with their partners to capture and share data, often this was a manual
process and highly error prone. Due to it being a manual process the sharing of data between organizations was time
consuming and caused significant delay in sharing results across the project.
Industrial production is becoming increasingly interlinked with modern information and communication technology. From the foundation of intelligent digitally-networked systems, a largely self-organized production will be possible. In Industrie4.0, people, machinery, plants, logistics and products will communicate and cooperate directly. To connect these different strands, a unified, flexible, high-performance system is needed to provide company-wide, real-time, information flow.
To target these issues, we developed enterprise:inmation.
It securely and efficiently gathers data from manufacturing, process control and IT systems all around the globe, contextualizes it and transforms it into actionable information, which is presented to every decision-maker on any device, anytime, at any location.
Software made by industrial system integration pros, in close cooperation with industry leaders. Business performance in real-time, anytime, anywhere, for all decision- makers -that is enterprise:inmation.
Scalable and Repeatable Machine Learning pipelines: A key requirement for you...All Things Open
This document discusses how Pachyderm helps data science teams overcome obstacles to effective data science by providing reproducibility, version control for data, and data provenance. It provides examples of how Pachyderm is used by AgBiome and General Fusion to build scalable data pipelines and comply with regulations like GDPR by enabling easy editing of data without disruption.
This document discusses Migros' use of Kafka as an enterprise integration platform. It provides a history of Kafka implementation at Migros over time, with milestones such as adding additional clusters and data sources. It discusses challenges that led Migros to move to an event-driven architecture, such as delays in data updates and a lack of standardized analytics ingestion. The document presents Migros' vision for an enterprise data integration platform and challenges around balancing governance, agility, and enterprise architecture management. It provides details on Migros' solution approach including topics, access control, and shared responsibility models between producers and consumers.
How to add security in dataops and devopsUlf Mattsson
The emerging DataOps is not Just DevOps for Data. According to Gartner, DataOps is a collaborative data management practice focused on improving the communication, integration and automation of data flows between data managers and consumers across an organization.
The goal of DataOps is to create predictable delivery and change management of data, data models and related artifacts. DataOps uses technology to automate data delivery with the appropriate levels of security, quality and metadata to improve the use and value of data in a dynamic environment.
This session will discuss how to add Security in DataOps and DevOps.
A Hybrid Cloud MultiCloud Approach to Streamline Supply Chain Data Flowjagada7
A hybrid multicloud system can effectively disseminate supply chain product information. It supports uploading item-by-item reports to traditional systems while also supporting industry-wide CMRT submissions and testing. Supplier data on multiple public and private clouds can be accessed by various departments for purchasing, design, manufacturing, and regulatory compliance. Reports evaluate substance thresholds in articles and parts, safe use information, renewability, and carbon footprinting. A hybrid multicloud provides flexibility, security, scalability, third party access, and cost effectiveness by using the best capabilities of different cloud technologies.
How Logilab ELN helps organizations to maintain ALCOA Data IntegrityAgaram Technologies
Data integrity, an area of increasing priority in today’s laboratory world and “The focus
area” when it comes to regulatory compliance such as 21 CFR Part 11 and Eudralex Annex 11.
The US Food and Drug Administration (FDA) guidance on data integrity, issued in
December 2018 (1), set new standards for all research companies. Under the new
guidelines, “firms should implement meaningful and effective strategies to manage their data integrity risks”.
Cloud Based Development for Medical Pharmacy and DCA ApplicationIRJET Journal
1. The document proposes a cloud-based integration framework using Boomi AtomSphere to connect electronic medical records from various drug agencies and medical pharmacies.
2. Data from different databases and systems would be integrated through Boomi's connectors and processes to enable sharing of medical records between pharmacies and drug control administrations.
3. This framework aims to improve data sharing and interactions between drug control authorities and medical pharmacies by developing a smart, connected system for medical records in the cloud.
RA TechED 2019 - SY08 - Developing Information Ready Applications using Smart...Rockwell Automation
This document discusses Rockwell Automation's approach to developing information-ready applications using smart tags and edge devices. It aims to reduce the effort required to create and maintain information applications by allowing automation engineers to select relevant device values and configure smart tags at the controller level. This enables auto-discovery and self-configuration of information applications, reducing technical knowledge barriers. It also increases data integrity by capturing data at the device level and allowing for faster collection rates.
The document discusses how cloud implementation can maximize ROI for laboratories. It explains that adopting a thin-client architecture hosted on the cloud provides benefits like high storage capacity, cost effectiveness, strong data security, and the ability for multiple simultaneous users. The cloud's pay-as-you-go model allows laboratories to access laboratory informatics software without large upfront hardware costs. Overall, the cloud enables laboratories to streamline operations while minimizing total cost of ownership.
Similar to Implementation of-logilab-sdms-in-the-biopharama-industry-for-vaccine-research (20)
The Key to Digital Success_ A Comprehensive Guide to Continuous Testing Integ...kalichargn70th171
In today's business landscape, digital integration is ubiquitous, demanding swift innovation as a necessity rather than a luxury. In a fiercely competitive market with heightened customer expectations, the timely launch of flawless digital products is crucial for both acquisition and retention—any delay risks ceding market share to competitors.
8 Best Automated Android App Testing Tool and Framework in 2024.pdfkalichargn70th171
Regarding mobile operating systems, two major players dominate our thoughts: Android and iPhone. With Android leading the market, software development companies are focused on delivering apps compatible with this OS. Ensuring an app's functionality across various Android devices, OS versions, and hardware specifications is critical, making Android app testing essential.
Mobile App Development Company In Noida | Drona InfotechDrona Infotech
Drona Infotech is a premier mobile app development company in Noida, providing cutting-edge solutions for businesses.
Visit Us For : https://www.dronainfotech.com/mobile-application-development/
Liberarsi dai framework con i Web Component.pptxMassimo Artizzu
In Italian
Presentazione sulle feature e l'utilizzo dei Web Component nell sviluppo di pagine e applicazioni web. Racconto delle ragioni storiche dell'avvento dei Web Component. Evidenziazione dei vantaggi e delle sfide poste, indicazione delle best practices, con particolare accento sulla possibilità di usare web component per facilitare la migrazione delle proprie applicazioni verso nuovi stack tecnologici.
What to do when you have a perfect model for your software but you are constrained by an imperfect business model?
This talk explores the challenges of bringing modelling rigour to the business and strategy levels, and talking to your non-technical counterparts in the process.
Project Management: The Role of Project Dashboards.pdfKarya Keeper
Project management is a crucial aspect of any organization, ensuring that projects are completed efficiently and effectively. One of the key tools used in project management is the project dashboard, which provides a comprehensive view of project progress and performance. In this article, we will explore the role of project dashboards in project management, highlighting their key features and benefits.
Hand Rolled Applicative User ValidationCode KataPhilip Schwarz
Could you use a simple piece of Scala validation code (granted, a very simplistic one too!) that you can rewrite, now and again, to refresh your basic understanding of Applicative operators <*>, <*, *>?
The goal is not to write perfect code showcasing validation, but rather, to provide a small, rough-and ready exercise to reinforce your muscle-memory.
Despite its grandiose-sounding title, this deck consists of just three slides showing the Scala 3 code to be rewritten whenever the details of the operators begin to fade away.
The code is my rough and ready translation of a Haskell user-validation program found in a book called Finding Success (and Failure) in Haskell - Fall in love with applicative functors.
Preparing Non - Technical Founders for Engaging a Tech AgencyISH Technologies
Preparing non-technical founders before engaging a tech agency is crucial for the success of their projects. It starts with clearly defining their vision and goals, conducting thorough market research, and gaining a basic understanding of relevant technologies. Setting realistic expectations and preparing a detailed project brief are essential steps. Founders should select a tech agency with a proven track record and establish clear communication channels. Additionally, addressing legal and contractual considerations and planning for post-launch support are vital to ensure a smooth and successful collaboration. This preparation empowers non-technical founders to effectively communicate their needs and work seamlessly with their chosen tech agency.Visit our site to get more details about this. Contact us today www.ishtechnologies.com.au
Top Benefits of Using Salesforce Healthcare CRM for Patient Management.pdfVALiNTRY360
Salesforce Healthcare CRM, implemented by VALiNTRY360, revolutionizes patient management by enhancing patient engagement, streamlining administrative processes, and improving care coordination. Its advanced analytics, robust security, and seamless integration with telehealth services ensure that healthcare providers can deliver personalized, efficient, and secure patient care. By automating routine tasks and providing actionable insights, Salesforce Healthcare CRM enables healthcare providers to focus on delivering high-quality care, leading to better patient outcomes and higher satisfaction. VALiNTRY360's expertise ensures a tailored solution that meets the unique needs of any healthcare practice, from small clinics to large hospital systems.
For more info visit us https://valintry360.com/solutions/health-life-sciences
Using Query Store in Azure PostgreSQL to Understand Query PerformanceGrant Fritchey
Microsoft has added an excellent new extension in PostgreSQL on their Azure Platform. This session, presented at Posette 2024, covers what Query Store is and the types of information you can get out of it.
E-commerce Development Services- Hornet DynamicsHornet Dynamics
For any business hoping to succeed in the digital age, having a strong online presence is crucial. We offer Ecommerce Development Services that are customized according to your business requirements and client preferences, enabling you to create a dynamic, safe, and user-friendly online store.
Microservice Teams - How the cloud changes the way we workSven Peters
A lot of technical challenges and complexity come with building a cloud-native and distributed architecture. The way we develop backend software has fundamentally changed in the last ten years. Managing a microservices architecture demands a lot of us to ensure observability and operational resiliency. But did you also change the way you run your development teams?
Sven will talk about Atlassian’s journey from a monolith to a multi-tenanted architecture and how it affected the way the engineering teams work. You will learn how we shifted to service ownership, moved to more autonomous teams (and its challenges), and established platform and enablement teams.
1. CASE STUDY
How Logilab SDMS helped a Leading COVID Vaccine
manufacturer achieve Data Integrity, Compliance &
Automation
WHATS’ UP WITH VACCINE DEVELOPMENT?
A leading Biopharmaceuticals organization who are an early innovator of COVID-19 vaccine
wanted to achieve automated process for achieving data integrity and compliance for their
manufacturing plant QC and research laboratories. They were looking for a computerised
system which is capable of handling the following complex compliance requirements along with
reliable infrastructure support.
Technical Requirements
✓ Able to work on cloud infrastructure
✓ Able to work with database running as Relation Database as Service
✓ Can store data in cloud
Core Functional requirements
✓ Support GMP requirements for quality control
✓ 21 CFR Part 11 compliance for instrument data
✓ Building a single source of truth
✓ Data Integrity
✓ Sharing data with other systems like LIMS