The Power of Experience!
PharmaSys 21 CFR Part 11 Header Picture
Take the Mystery out of 21 CFR Part 11 Compliance

PharmaSys Part 11 Puzzle21 CFR Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in FDA regulations.

PharmaSys has provided 21 CFR Part 11 compliance planning, training, audits/assessments, and remediation services to hundreds of customers since 1997. 

We've done everything from system assessments and validation for Part 11 compliance to architecting Part 11 compliance programs. We've helped pharma, biotech, CROs and software suppliers comply.

Let us show you our risk based approach to Part 11 compliance that minimizes your cost and maximizes your conformance with Part 11.

Since 1998, PharmaSys has completed over 600 engagements with no 483 or warning letter observations. Our record speaks for itself!


Experience is everything when Part 11 is concerned
Important Part 11 Information
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