Six Steps to Part 11 Compliance

Document archiving is another requirement of 21 CFR Part 11. A document management system integrated with other applications such as device configuration editors and HMI applications can allow users to archive process data and system configurations, as well as computer-assisted design (CAD) files and standard operating procedures (SOPs). This also can provide features such as check-out/check-in, file locking, "mastering" the current revision and automatic revision numbering. Additionally, all transactions with the document management repository should create an audit trail to maintain records in compliance with 21 CFR Part 11 regulations. Once a company understands the main functions defining 21 CFR Part 11, it is important to develop a plan for meeting compliance. The steps detailed in the sidebar ("A Six-Step Program") can help pharmaceutical facilities develop a master compliance plan. As the facility completes each step, it should clearly see the areas that require compliance-enabling systems. Many companies do not yet have the bandwidth or past experience to brave compliance on their own. In these cases, 21 CFR Part 11 consultants are available to help interpret the code and define areas of the facility in which 21 CFR Part 11 will have an impact. One of the most beneficial aspects of a consultant is single-source accountability. This one-point contact helps coordinate multiple production areas, promoting consistency between groups and reducing internal resource requirements. Consultants can help assess, develop and implement master compliance plans to cover both new and legacy systems. For many pharmaceutical companies, compliance with government regulations still seems like a necessary evil instead of an opportunity to increase profitability. Despite its number of controls, 21 CFR Part 11 is one of the few regulatory actions that industry sought to enable the use of advances in electronic documentation. By combining an understanding of the regulations with a solid plan of