e- Systems

When used for GxP regulated and business critical activities, GxP computer systems must be audited and must follow the requirements set forth by prevailing legislation in order to be viewed as reliable, and their data integrity as being preserved.

Drug Safety Consult can offer to audit the validation, use and maintenance of internal E-Systems and systems used at partners, vendors, or hospital sites.

System compliance is impacted by global regulations for GCP, Pharmacovigilance GVP, and 21CFR part 11 for e-records and signatures.

Contact  here.

​

View Dr. Lisbeth Tofte's handbook: A User's Guide to Computer Validation