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Take the Mystery out of 21 CFR Part 11
Compliance
 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 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.
Science 1998., PharmaSys has completed over 600
engagements with no 483 or warning letter
observations. Our record speaks for itself!
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Experience is everything when Part 11 is
concerned
We've successfully
completed more than 300 projects
with Part 11 implications without a
single 483 or warning letter
observation.
Our approach is
simple: Use our own personnel who
have real industry experience
instead of theory, then access to our
collective knowledge on the subject.
Experience makes a difference!
Important Part 11 Information
FDA To Conduct Inspections
Focusing on 21 CFR 11 More...
21 CFR Part 11 - Electronic Records;
Electronic Signatures
More...
FDA Guidance for Industry, 21 CFR Part
11, Electronic Records; Electronic
Signatures - Scope and Application
More...
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