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.
Read one of your own drawings.
Drop a P&ID, instrument index, or schedule. Tagsight reads it to the tag and opens a workspace you keep when you sign in.
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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.
URS trace refresh after a P&ID revision
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.
Periodic review evidence pull
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.
Tech transfer to a contract site
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.
FAQ.
Does Tagsight understand GAMP 5 or 21 CFR Part 11.
Tagsight is the data-source layer. It produces structured, source-traceable extractions that feed into your GxP-validated workflow. The validation status of the receiving system, including 21 CFR Part 11 controls, lives in your validated tool. Tagsight does not change the regulatory boundary.
Can extractions be retained for the validation lifetime of the asset.
Workspace data and audit history are retained per your account configuration. For long retention against a validated asset, the structured exports can also be archived in your own document management system. The structured form is portable.