FDA Inspection Readiness

This workflow describes how to use Clarix to systematically verify that your 503B outsourcing facility is inspection-ready across all five readiness pillars. Use this guide in the weeks before a scheduled inspection or as part of an ongoing readiness program.

Readiness pillars overview

Pillar 1 — Verify training matrix

Role required: Training Manager, QA Officer

1. Navigate to Training → Personnel Matrix.
2. Review the matrix for all active staff. Look for:
   • Any overdue training assignments (shown in red)
   • Staff with upcoming training expiries within 30 days
   • New SOPs or procedures not yet assigned to relevant personnel
3. For each overdue item:
   • Contact the staff member and schedule completion.
   • If the gap is risk-significant (e.g., a technician who performs batch steps has overdue GMP training), raise a deviation per your SOP.
4. Confirm that all active staff performing GxP activities are current on required training before the inspection date.
5. Export the training matrix report from Reports → Training Summary for the inspector's review packet.

Note: Inspectors frequently request training records for specific personnel who signed batch steps. Ensure Clarix training records are linked to the same user identity that signs batch records.

Pillar 2 — Check EM excursions

Role required: Microbiology / EM Coordinator, QA Officer

1. Navigate to Environmental → Excursions.
2. Filter for the inspection period (typically the previous 12 months or since the last inspection).
3. Verify that every excursion has:
   • A linked investigation or root cause assessment
   • A resolution status (Closed or In Progress with documented justification)
   • A linked CAPA if the excursion was significant or recurring
4. For any open excursions:
   • Confirm the investigation is active and has a due date.
   • Escalate as needed to ensure closure before the inspection.
5. Review EM trending data for alert and action level trends. If a trend is approaching an action level, document a proactive assessment.
6. Export the EM excursion report from Reports → Environmental Summary.

Edge case: If an EM excursion is still open at the time of inspection, prepare a written summary of the investigation status, interim controls in place, and expected closure date. Do not attempt to force-close an investigation before it is genuinely complete.

Pillar 3 — Confirm calibrations current

Role required: Equipment Manager, QA Officer

1. Navigate to Equipment → Calibration Dashboard.
2. Review the calibration status of all critical and major instruments:
   • Overdue calibrations must be resolved immediately — schedule and complete before the inspection.
   • Instruments due within 30 days should be prioritized for proactive calibration.
3. For any instrument used in a batch during the inspection period that had a calibration gap:
   • Review the batch records where the instrument was used.
   • Raise a deviation if required by your SOP.
4. Confirm that calibration certificates from external vendors are attached to each calibration record in Clarix.
5. Export the calibration status report from Reports → Equipment Calibration Summary.

Note: Inspectors may ask to see the calibration certificate for a specific instrument used in a batch they are reviewing. Having these directly attached in Clarix allows instant retrieval.

Pillar 4 — Confirm batch records released

Role required: QA Officer, PIC

1. Navigate to Batches → Pending QA and Batches → Awaiting PIC.
2. These queues should be empty or reduced to the minimum for batches within their normal review cycle.
3. For any batch that has been pending QA beyond your SOP-defined review timeline:
   • Investigate and expedite the review.
   • Document the reason for delay if it will be open during the inspection.
4. For batches within the inspection window that are already released:
   • Spot-check a sample of released batch MBRs for completeness.
   • Verify all QA and PIC signatures are present with correct timestamps.
5. If an inspector requests a specific batch record, navigate to Batches, search by batch number, and export the MBR PDF from Batch → Exports.

Pillar 5 — Control tower green

Role required: QA Director, Compliance Officer

1. Navigate to Reports → Control Tower (or Dashboard if your facility uses the overview dashboard).
2. The control tower aggregates open flags across all modules:
   • Open deviations by severity
   • Overdue CAPAs
   • Overdue training
   • EM action levels
   • Calibration overdue count
   • Pending QA batches
3. For each open flag:
   • Assess whether it represents a genuine quality risk.
   • Ensure each item has an owner and a documented action plan.
4. Prepare a written status summary for any items that will be open during the inspection. Inspectors will ask about open items — having a prepared summary demonstrates control.
5. The control tower report can be exported from Reports → Control Tower Export.

Pillar 6 — Generate audit packet

Role required: QA Director, Compliance Officer

1. Navigate to Reports → Audit Packet.
2. Configure the date range for the inspection period.
3. Select the modules to include in the packet:
   • Batch records (released in the period)
   • Training matrix
   • EM summary and excursion log
   • Equipment calibration summary
   • Deviation and CAPA log
   • OOS log
4. Click Generate Packet. Clarix compiles the selected reports into a structured PDF export.
5. Review the packet before the inspection. Correct any discrepancies by addressing the underlying records in Clarix (not by editing the export).

Note: Generate the audit packet as a snapshot on a specific date. If records change after generation (e.g., a batch is released), regenerate the packet to reflect the current state.

Edge cases

Related pages

• Audit Packet
• Personnel Matrix
• Environmental Excursions
• Equipment Calibration
• Reports Overview