IT Experts (Systems validation)
Any safety database being used for storing patient data and to submit data to any Regulatory Authorities for determination is subject to both EU and USA legislation (namely 95/46/EEC and 21 CFR Part 11 compliance respectively).
The databases have to be validated to a very high Regulatory standard. PharSafer® can help in this aspect too, working together with IT professionals in data transfers, PharSafer® can provide the necessary checks to warrant inclusion of legacy data to be transferred into any validated safety database and provide the necessary tests done to satisfy Regulatory Authorities.
We can help in safety database implementations, having successfully managed eight global database installations at various Companies and helped with the RFP, User Requirement Specification (URS) and the design/configuration of the databases.