and Remediation Services for|
21 CFR Part 11 (Electronic Records and Electronic Signatures)
Valoit was founded on its capabilities in the area of computer systems validation. Our success is attributed to the hands-on experience of our validation experts with a number of different types of computer systems. Our computer systems validation expertise includes:
a result of the growing dependence on information technology in
FDA-regulated industries, the FDA now defines under what circumstances
companies can use electronic records and electronic signatures in lieu of
handwritten records and signatures. This regulation is known as 21 CFR
Part 11 (Electronic Records and Electronic Signatures).
1997, when 21 CFR Part 11 became effective, Valoit’s computer
system validation experts have been hard at work, keeping abreast of the
FDA’s ever-increasing focus on enforcement of this regulation and
helping clients bring their new and existing systems into compliance.
legacy systems do not meet the requirements of 21 CFR Part 11. Although
the FDA has granted the industry a reprieve from major enforcement action
when systems are found non-compliant, they are requiring firms to audit
their current systems for Part 11 deficiencies and develop plans to bring
legacy systems into compliance. To help clients with this challenging
requirement, Valoit uses its understanding and expertise to
undertake large 21 CFR Part 11 remediation projects, managing and
executing every part of the effort, and offering proven tools and
methodologies to ensure timely and accurate completion.
consulting companies perform a mock FDA audit and help identify where your
systems are out of compliance. We’ll perform an audit. We’ll tell you
what you need to do to bring your systems into compliance. But then
we’ll roll up our sleeves and get to work to achieve the desired
We won’t just tell you what’s wrong – we’ll help you get it right!