HOTLINE 24/7/365 UK: +44 (0) 1483 212150

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.

PharSafer® Tweets

The @FDA_Global has updated their summative COVID-19 response document, with amendments made for latest activities… t.co/j9oudR40O0

Read on Twitter...

@MedDRAMSSO have issued their official 'patient friendly' MedDRA list, fully compliant with the latest MedDRA versi… t.co/8dK50LBnWt

Read on Twitter...

The @FDA_Global has released a report regarding drug shortages for the calendar year 2019, with key considerations… t.co/L7HkKvfYqe

Read on Twitter...