Phase I review does not close the OOS or release a batch. Phase II investigation, result invalidation,
final closure and batch disposition are not recorded in Invariant. A reviewed record shows that its
overall outcome is unresolved.
Who can do what
Original result
Each record holds one original result. Required fields are OOS title, Product, Batch / lot, Test, Method identifier and version, Specification reference, Acceptance criterion, Original reported result and Test date and time (UTC). Optional fields include the sample reference, units, instrument reference, source report or certificate of analysis reference, and a linked material. The source report reference is optional at creation but required before Phase I can be submitted. Name the analyst by choosing an Analyst account or entering an External analyst name. A name-only external analyst cannot be checked for account independence. You also set the Phase I investigator and the Phase I due date when you create the record. The investigator cannot be reassigned during Phase I. Before the first submission, a transcription error in the original result can be fixed with Correct a transcription error before submission. The correction needs a reason and is written to the tamper-evident audit trail. After the first submission the original result is frozen, even if the investigation is later returned.Phase I investigation
The Phase I laboratory investigation section has five checks: Calculation, Method and specification, Sample integrity, Equipment and calibration and Records. Each check takes a result (Not assessed, OK, Issue found or Not applicable) and a note. The investigator also records:- Findings.
- Phase I outcome: Assignable laboratory cause, No assignable laboratory cause or Inconclusive. An assignable cause also requires the laboratory cause.
- Recommended next step: Phase II investigation, Retest or resample plan, Invalidation proposal or No further laboratory action. This is a recommendation; Invariant does not run the next step.
- Optional links to a deviation and a CAPA. Linking does not change the linked record.
Statuses
A reviewer can also return a submitted investigation to Phase I open with a signed return. Review and
return each need a reason of at least 10 characters and password re-entry. The signature covers the
original result, the Phase I content, the follow-up links and the reason.
The review or return must be signed by an independent QA Manager or Administrator. The record’s
creator, investigator, account-linked analyst, submitter and anyone who edited its content cannot sign.
After review, an empty deviation or CAPA link can still be filled once with Add follow-up link. A
link added this way is labelled as added after Phase I review and is not part of the signed snapshot.
Attachments, PDF and reminders (where enabled)
These extras need a second organization setting for OOS records, which is also off by default.- Attachments: the Attachments / evidence panel accepts PNG, JPEG or PDF files up to 25 MB, in any Phase I status. The file content must match its type. Adding evidence does not change existing Phase I signatures. Attachments also require the attachments feature.
- Record PDF: where record PDF export is also enabled, Download OOS PDF produces a PDF of the record fields, the Phase I review, signatures, attachments with their SHA-256 digests and linked records. The PDF states that Phase I review is not the final OOS disposition and does not include the full activity timeline.
- Phase I reminders: where in-app notifications are enabled, the Phase I investigator gets a notification in the Notifications menu when the Phase I due date is within 3 days and again once it has passed. Reminders stop once Phase I is reviewed.
- Quality Calendar: Show OOS Phase I dates adds each record’s Phase I due date to the calendar. See Quality Calendar.