Computer system validation (CSV) relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA has been regulating CSV for more than 30 years now. The requirements ensure that any computerized system used for collection, analyzing and/or reporting data has been taken through a thorough all phases of planning, implementation, integration, testing and management.
Back in the year 1997, the FDA established guidelines on Electronic records and electronic signatures (ER/ES) which were disseminated through 21 CFR Part 11. This code of regulations describes the basic requirements for validating and documenting ER/ES capability in systems used within an FDA-regulated environment.
In the early 2000s, FDA urged industry to take responsibility and begin assessing all regulated computer systems based on risk. This came into being as the FDA recognized they could not inspect every computer system at every regulated company. The level of potential risk would form the basis for each company’s approach to developing a validation approach and rationale as part of the planning process should the system fail to operate properly. The five key components would include: system size, complexity, business criticality, GAMP 5 category and risk rating. These would determine the scope and robustness of testing required ensuring data integrity and product safety.
From the FDA’s CSV inspections and audits given the focus on data integrity in the recent years, the importance for compliance of systems used in regulated industries has become paramount. This would include all systems that “touch” product, meaning they were used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data must be managed and maintained with integrity throughout their entire life cycle. This would include databases, and unstructured data, documents, spreadsheets, presentations, and images, audio and video files, amongst others.
Through this webinar, we will explore the best practices and strategic approach for evaluating computer systems for FDA-regulated activities. We will also learn to determine the level of potential risk or threat, should the system fail with regard to data integrity, process and product quality, and consumer/patient safety. We will take a detailed view of System Development Life Cycle (SDLC) approach to validation. Risk assessment tools will be examined, and will also discuss 21 CFR Part 11. We will gage the importance of managing electronic records and signatures appropriately using relevant examples.
We will evaluate all essential policies and procedures, including supporting documentation and activities that must be established and followed to ensure compliance. This webinar will deliver an overview on best practices to prepare for an FDA inspection. This session will also touch on the significance of auditing vendors of computer system hardware, software, tools and utilities, and services.
Overall, you will learn to leverage industry best practices using risk assessment tools with attention to data integrity to support all your GxP work ensuring compliance.