21 CFR Part 11
Overview
"...FDA will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to handwritten signatures. Part 11 (21 CFR part 11) applies to any paper records required by statute or agency regulations and supersedes any existing paper record requirements by providing that electronic records may be used in lieu of paper records."
The FDA is enforcing the part 11 regulations with the purpose of assure the critical electronic data generated into the operation of computer systems, will be always accurate and available.
CIE has the expertise and the commitment to develop systems that comply with all requirements established in these regulations, and to challenge the system in order to generate enough documented evidence that guarantee the system's compliance.
Also, we can work with you in the assessment of your legacy systems to establish a strategy that leads to their compliance with the 21 CFR Part 11 requirements.