He has completed more than 240 mission critical laboratory, clinical, and manufacturing software implementation projects. Got me to think about validation a different way, the end users’ perspective. Drug and medical device manufacturing in the modern world relies increasingly on computerized systems.Projects are typically completed in one-third the time of any other approach.This means the system is up and running with trained users in a third of the time too.By verifying the controlled development and implementation of computer systems, we can help our clients ensure the integrity, reliability, and availability of their regulated business data to support the production of quality products and ultimately protect patient safety.
Suppose that a document management system is being implemented at a young company in the pharmaceutical field.Being highly regulated industries, ensuring quality and accuracy of data is paramount; and thus, Computer System Validation (CSV) is necessary to assure that critical processes are functioning properly.FDA: Examples of Computer Systems The FDA defines process validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes." The objective of validation, therefore, is to produce documented evidence that parts of the facility will work correctly every time, when brought into use.Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation.He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. Pro Pharma Group provides a broad range of Computer System Validation (CSV) services in support of our clients’ manufacturing, laboratory, and enterprise systems.We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical, risk-based approach to CSV.There are several variations to the GAMP V model but one of the most common ones is displayed below.These go in order from the top left to the top right.Specific requirements for computers can be found in section 211.68 of the US c GMP regulations Recent Warning Letters and 483's Related to Computer Validation and Part 11 With Case Studies to Avoid and Respond to 483's and Warning Letters The FDA has developed several specific guidance documents on using computers for other FDA regulated areas.Most detailed is the Industry Guide: General Principal of Software Validation: (2).