Tagsight for validation engineers.
Every instrument on a GxP P&ID has to trace back to a user requirement, a functional spec, an IQ, OQ protocol, and a calibration record. Half your job is the validation engineering itself. The other half is keeping the trace matrix in sync with a drawing set that revises every other week.
What you do today.
- Walk every P&ID page, transcribe each GxP-tagged instrument into the URS trace
- Cross-reference against the FS and the IQ, OQ test scripts, find the gaps
- Re-issue the trace matrix every time the drawings revise
- Defend the matrix in the periodic review with a paper trail nobody trusts
What changes with Tagsight.
- Pull the GxP-tagged instrument list off the current P&ID set in one extraction
- Diff against the previous URS-validated baseline so the trace matrix stays current
- Carry source-page metadata on every tag so the periodic review trace is one filter
- Export the trace data into the column shape your validation system expects
Where it fits in your week.
Engineering issues a new IFC. Run the diff, attach the new and removed tags to the URS trace update, route through change control. The validation impact is scoped from data instead of from a paper walk.
Annual periodic review wants every GxP instrument traced to its protocol. Filter the extraction to GxP-tagged instruments, hand the auditor a list with source pages and revision stamps.
Drug-product transfer to a CMO requires the upstream P&ID set to be fully traced into the receiving site's URS. Run the source drawings, hand the receiving site a structured baseline, skip the manual re-trace step that usually owns the schedule.
Common questions
Does Tagsight understand GAMP 5 or 21 CFR Part 11.
Can extractions be retained for the validation lifetime of the asset.
Put it to work.
Every instrument on a GxP P&ID has to trace back to a user requirement, a functional spec, an IQ, OQ protocol, and a calibration record. Half your job is the validation engineering itself. The other half is keeping the trace matrix in sync with a drawing set that revises every other week.