Consulting and Remediation Services for
21 CFR Part 11 (Electronic Records and Electronic Signature

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:

  • Automation Systems
  • Laboratory Systems
  • Information Systems
  • Robotics

As 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).

Since 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.

Many 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.

Many 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 results.

We won’t just tell you what’s wrong – we’ll help you get it right!

Validation 21CFR Part 11 Services Regulatory Compliance Startup & Commissioning
SAP Validation ERP Validation
Training Approach FDA Compliance Training SAP End User Training
Prior to Production Startup Equipment Validation Facilities Validation Computer System Validation

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