Data Integrity: Do You GAMP?

For those of you in development and/or implementation of automated production systems, or considering revising your data integrity strategy, following good automated manufacturing practices (GAMP^®) guidelines may be the best method to achieve your desired goals. The GAMP guidelines have undergone a significant review by the international pharmaceutical industry and regulatory subject matter experts, and the processes have been successfully deployed at many pharmaceutical companies large and small. As we all know, computer systems are at the crux of every decision made within a life sciences company, and they control many processes in manufacturing and laboratories. With the increase of data integrity issues, regulatory focus on computerized systems has amplified. Now more than ever, practical industry guidance is critical when establishing or re-evaluating strategies to achieve compliant computerized systems. Companies that develop a data integrity program using the GAMP guidelines have a better chance of ensuring their systems function in the way they are intended—safeguarding product quality and patient safety as well as meeting regulatory needs. While it is preferable and easier to apply GAMP principles from cradle to grave, companies that are considering introducing these practices can still benefit by applying them to support existing systems as well. Before developing your data integrity strategy, I recommend you ensure that all your contributors have a practical understanding of the tools and techniques needed to establish compliant computerized systems. As an instructor of the ISPE GAMP® Data Integrity 21 CFR Part 11 training course, I can tell you that there are many advantages to completing such training including:

• Understanding why data integrity has become a regulatory hot button, including current regulatory thinking, with emphasis on MHRA and FDA concerns
• Learning the vocabulary of data integrity
• Gaining knowledge of how the various life cycles (system, project, data, and records) align
• Interacting with people in similar roles at other companies, and learning what challenges they’ve encountered and the strategies they’re using to resolve them

As data integrity is increasingly the focus of regulatory agencies, it is important that your team understands the challenges and utilizes powerful resources like the GAMP guidelines to ensure compliance.