Towards Computer System Validation: An overview and Evaluation of Existing Procedures

Schönberger, Marius; Vasiljeva, Tatjana

doi:10.5171/2018.512744

Cited by 4 publications

(2 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The approval plan depicts all exercises, for example, audit of the user requirement speci ication, a survey of improvement plan (structure), testing methodology, check of information movement (if it is pertinent), audit of the approval archives and the acknowledgement testing the entire framework. The arrangement incorporates the date, the dependable individual, along with acknowledgement criteria data for each survey or test, or if nothing else, a reference to these tests (Schönberger and Vasiljeva, 2018). The approval plan is to be approved by a capable individual before beginning the approval.…”

Section: Approval Planmentioning

confidence: 99%

Implementation of Good Computer System Validation Practices In Pharmaceutical Industry- A Review

Sharvani

Jain

Kumar

et al. 2021

ijrps

View full text Add to dashboard Cite

Computer Systems Validation is a method used to ensure information is generated by a computer-based system that satisfies a set of specified requirements. Compliance with computerized systems is becoming increasingly relevant in the pharmaceutical industry as computer system validations have many benefits, such as enhancing quality control, reducing other validation costs and time, improving compliance with GMP 21 CFR Part 11 Regulation which affects the quality, health, identification or effectiveness of products subject to the GMP Regulations. Both the European Medicines Agency of Europe along with the Food & Drug Administration of the USA has developed CSV practice guidelines. An overview of relevant documents which fulfil the computer system validation along with its best practices implemented is presented below. Official requirements and standards of the USA, Europe, and Switzerland are taken as the main focus. The taken basic GMP guidelines' like Gamp, AVP and PDA implies the same principles and theories. They explain majorly about what to do view point of validation, whereas GAMP describes how to do validation. We strive to define the computer device validation needs of equipment conducted from a pharmaceutical industry perspective. The categorization of a computer system into various frameworks or categories gives the flexible approach for the validation of complex as well as simple computerized systems. The present review article discusses the implementation and various good practices of the pharmaceutical industry to maintain computer system validation. Implementing various good computer system validation activities reduces the re-work and always maintains the quality standards as per the user requirements; as a result of which the future trends will notice merging of various new implemented terminology and techniques as a common practice in mixed sectors.

show abstract

Section: Approval Planmentioning

confidence: 99%

Implementation of Good Computer System Validation Practices In Pharmaceutical Industry- A Review

Sharvani

Jain

Kumar

et al. 2021

ijrps

View full text Add to dashboard Cite

show abstract

“…Following the prescribed validation of software, several official guidelines like the FDA'S "General principles of Software Validation" [16] or the European Commission's "Good Manufacturing Practice (GMP) guidelines Annex 11: Computerized Systems" [17] as well as industry specific approaches were developed in the recent decades [18]. Following the regulatory guidelines, the approaches are predominantly linear and sequential.…”

Section: Introductionmentioning

confidence: 99%

Validation of AI-based Information Systems for Sensitive Use Cases: Using an XAI Approach in Pharmaceutical Engineering

Polzer¹,

Fleiß²,

Ebner³

et al. 2022

Proceedings of the Annual Hawaii International Conference on System Sciences

View full text Add to dashboard Cite

Artificial Intelligence (AI) is adopted in many businesses. However, adoption lacks behind for use cases with regulatory or compliance requirements, as validation and auditing of AI is still unresolved. AI's opaqueness (i.e., "black box") makes the validation challenging for auditors.Explainable AI (XAI) is the proposed technical countermeasure that can support validation and auditing of AI. We developed an XAI based validation approach for AI in sensitive use cases that facilitates the understanding of the system's behaviour. We conducted a case study in pharmaceutical manufacturing where strict regulatory requirements are present. The validation approach and an XAI prototype were developed through multiple workshops and then tested and evaluated with interviews. Our approach proved suitable to collect the required evidence for a software validation, but requires additional efforts compared to a traditional software validation. AI validation is an iterative process and clear regulations and guidelines are needed.

show abstract

How Computer System Validation Contributes to Performance Improvements for Medical Device Manufactures: The Case of Latvian SME

Schönberger

Vasiljeva

2020

Lecture Notes in Networks and Systems

View full text Add to dashboard Cite

Towards Computer System Validation: An overview and Evaluation of Existing Procedures

Cited by 4 publications

References 4 publications

Implementation of Good Computer System Validation Practices In Pharmaceutical Industry- A Review

Implementation of Good Computer System Validation Practices In Pharmaceutical Industry- A Review

Validation of AI-based Information Systems for Sensitive Use Cases: Using an XAI Approach in Pharmaceutical Engineering

How Computer System Validation Contributes to Performance Improvements for Medical Device Manufactures: The Case of Latvian SME

Contact Info

Product

Resources

About