“We are proud to announce that our company recently joined BPOG -
one of the organizations that we see having greater alignment with the
transformations the biopharma industry is undergoing.”
With the aim of improving its Quality Risk Management (QRM) activities,
Merck has chosen 4Tune Engineering’s solution.
iRISKTM will be the integrative QRM platform for Merck’s
products and processes entire lifecycle. iRISKTM proprietary
features, user-friendliness, versatility and efficiency was praised by
Merck’s users as the best fit for their worldwide needs.
- U.S. FDA issued 143 warning letters
- EMA issued 112 noncompliance reports (NCRs)
- Of these, 115 CGMP violations were identified