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Computer System Compliance with 21 CFR

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By Agustina Jansen - Tuesday, February 12, 2008

Computer System Compliance with 21 CFR Part 11 for Electronic Records and Electronic Signatures Without Consultant Fees

Seattle, Washington, February 12, 2008 (PRAvenue) -“ Agustina Jansen is launching a hands-on process for documenting compliance with 21 CFR Part 11 for electronic records and electronic signatures - no consultants required!

Compliance with 21 CFR Part 11 is now being enforced by the FDA and evidence of compliance must be provided at time of FDA audit. Because of this law, there are suddenly many consultants offering their services for bringing your systems under compliance with Part 11. The methods used by consultants are complex and time consuming. Using consultants for this purpose is also costly €“ costing thousands of dollars “ and leaving the System Owner with a lack of understanding of how their own systems comply with the rule. This is a clear disadvantage when defending computer systems e-records and e-signatures to the FDA.

The author of this consultant-free Part 11 assessment process realizes that the basic understanding of the rule and how it applies to computer systems is required for successfully defending computer systems to the FDA. She also understands that this means hands-on analysis and assessment of computer systems by System Owners. A hands-on solution is what Agustina has developed. Documenting computer system compliance with Part 11 becomes effortless and the completed documentation provided the evidence needed to defend computer systems. The how, why, when, and where of attaining compliance are well understood by the System Owner because the System Owner is the author and analyst! This is the solution to compliance “ to document the evidence they have personally verified to be correct and complete. All of this is accomplished by the System Owner without consultant fees! The cost for this package is currently being offered for $600 as an introductory price.

Contact Name : Agustina Jansen
Phone : 425 941 0925
email :
website :
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