Anna Smith·1d ago340B Integrity at Scale: Connecting Detection, Investigation, and Evidence340B purchases reach $100 billion, manufacturers need a reviewable way to connect data, investigate potential issues, and substantiate what…
Mahtab Shardi·Nov 2FDA 21 CFR Compliance: Why Signed Records Can Still Leave Critical GapsEvery SOP is approved. Every batch record is complete.Every required signature is in place. So why might the release decision still be…
Creaton Poh·Oct 28Can a GMP Factory Use Generative AI in Production?Europe’s draft GMP annex on artificial intelligence draws a line every regulated factory should read: generative AI stays out of decisions…
Mahtab Shardi·Oct 12Pharmaceutical Risk Assessment Isn’t Just Paperwork: What GMP Teams Must ProveThe risk assessment is approved, every box is checked, every signature is in place, but can anyone prove the controls work?
Mahtab Shardi·Oct 5Your Pharmaceutical Risk Assessment May Look Complete, That Does Not Mean the Risk Is ControlledMost pharmaceutical risk assessments fail long before anyone enters a number into a matrix.
