How do you get a 21 CFR Part 11 compliant system?

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As 21 CFR Part 11 has been mandatory since 1997, most pharmaceutical companies have done the job to get their regulatory systems into compliance with this rule.

Provided the company is affected, each computer system needs to be assessed for compliance, and brought into compliance. Read more about case studies of Part 11 projects.
It might be wise first to create an inventory of the systems in the company, and create a checklist of items required in 21 CFR Part 11.

1: Assess if the system itself needs to be in compliance. Does it handle GxP data? GxP systems include data that affects the quality of the products.

2. Check each system according to the checklist. Create an overview of where the problems are.

3. Create an action plan for each system
Some problems can be solved internally; others need help from the supplier. Sometimes it is not possible to solve the problems with the system. In that case another system may take over the job for this system, or a completely new system must replace the existing. In that case, create a URS.

Solutions may include:
• Writing to the supplier and hope that he can help you with the technical non-compliance in the system. This may be incorporated in the next version.
• Create or change SOPs to include all procedural requirements in 21 CFR Part 11. This should be done without delay.
• Validate all technical requirements set forth in Part 11. Chances are that even if your system was validated, some of these issues were missing during the testing. Validation activities should be done without delay.

4. Create an overall action plan for your systems. It is probably not possible to fix all problems quickly, as there are usually limited resources to do so. In that case, make a priority list of the systems to be worked on. Priorities are based risks: How important each system is for the company and how much it is used. Start with the top system and work down the list.