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Use this procedure where OOS records are enabled for your organization. For field and status details, see OOS Records.

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Record the result

  1. Go to Quality Management → OOS.
  2. In Record a new OOS result, enter the original result as it was first reported.
  3. Choose the Analyst account, or enter an External analyst name.
  4. Choose the Phase I investigator and the Phase I due date.
  5. Select Create OOS record. The record opens in Phase I open.
To fix a transcription error before the first submission, use Correct a transcription error before submission. Enter a reason and select Save audited correction.

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Complete Phase I

  1. Open the record. The investigator or a QA Manager can edit Phase I.
  2. In Phase I laboratory investigation, set a result and a note for each of the five checks.
  3. Enter the Findings, the Phase I outcome and the Recommended next step.
  4. Link a deviation or CAPA if one exists.
  5. Enter a reason and select Save Phase I investigation.
  6. Where attachments are enabled, upload supporting evidence in Attachments / evidence.

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Submit for review

  1. Confirm the source report or certificate of analysis reference is filled in.
  2. As the investigator, enter a reason and select Submit saved Phase I for review.
The original result is now frozen. Phase I content is frozen while the record is in review.

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Review or return

  1. Sign in as an independent QA Manager or Administrator.
  2. Open the record and enter a reason.
  3. Select Review Phase I, then Sign Phase I review. Or select Return investigation, then Sign return.
  4. Re-enter your password to sign.
A returned record goes back to Phase I open. A reviewed record is frozen. Phase I review does not close the OOS or release a batch: record the next step under your approved procedure.
Where record PDF export is enabled, select Download OOS PDF to save a copy of the record for review or audit.