21 CFR Part 11
ARD Scientific LLC helps clients to ensure sustainable compliance with 21 CFR Part 11 by providing regulatory and project management expertise, as well as, manpower for timely completion of the projects.
We utilize regulatory risk-based approach in all 21 CFR Part 11, Computer System Validation (CSV) and IT Management projects enabling the client to successfully defend validity and accuracy of the critical clinical, nonclinical, and manufacturing data and results during regulatory and 3rd party's inspections and reviews.
Ordinarily, ARD Scientific LLC consultants utilize proprietary 21 CFR 11 & Validation Assessment, 21 CFR Part 11 & Computer Systems Strategic Planning, and Computer Systems Validation SOPs and a set of applicable to the process templates. At the client's request, however, our consultants will be trained and will use the client's internal procedures & templates.