In-house Systems - Create 21 CFR Part 11 Compliance Documentation |
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Description |
Advantages of Hiring FDASmart |
Class We Developed So Others Can Learn From FDASmart Experience (1) |
When companies develop in-house computer systems with insufficient information to prove FDA compliance, there’s a need to produce documentation (including SOPs) to pass any potential FDA audit. |
Applying our 15 years of experience in software development, We can reverse engineer the information and documentation a computer system requires to be 21 CFR Part 11 compliant. |
“Auditing Information Systems – Are You and Your Vendors Part 11 Compliant?” |
(1) Contact us and the table of contents from any class can be emailed to you |
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