Compliance and Validation Services Stuff

Part 11 Compliance Audits & Assessments

Part 11 Compliance Remediation

Part 11 Compliance Program Development

Part 11 Validation

Part 11 Training

21 CFR Part 11, Compliance Consulting

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21 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 successfully completed more than 200 projects with Part 11 implications without a single 483 or warning letter observation.

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

Our approach is simple: Use our own personnel who have have real industry experience instead of theory and access to our collective knowledge on the subject. It makes a difference!

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

 

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