Guarantee the use of electronic technology instead of high cost, time consuming paper systems. This is the objective of the validation services offered by SoftExpert.
As part of our methodology, we provide confirmation by examination and provision of objective evidence that your computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled in a regulatory compliant manner.
The Validation Services are evidence of SoftExpert solution conformity with the FDA 21 CFR part 11 regulations. This ensures that electronic records and signatures are considered as trustworthy, reliable and legally valid as paper records.