Free GDP/GMP audit-readiness check for temperature mapping

An audit readiness check is a structured self-assessment that compares your temperature mapping and monitoring documentation with the points GDP, GMP and pharmacy auditors typically review in practice. You answer questions about setup, study design, calibration, monitoring and reporting. The result is a report showing which areas are already well covered and which still need attention.

No. The audit readiness check is a practical self-assessment based on your own answers. It helps you identify gaps in your documentation before an auditor raises them, but it does not replace a formal GDP, GMP or ISO audit by an accredited party. For an independent review of your protocol, raw data and CAPA, you can request an external assessment.

The questions align with EU GDP (2013/C 343/01), GMP Annex 15 (Qualification and Validation), WHO Technical Report Series, ISPE Good Practice Guides and real-world IGJ inspection findings. Topics such as initial mapping, acceptance criteria, monitoring position, ALCOA+ and periodic requalification are directly traceable to these guidelines.

The check is written for QA, QP, validation and compliance professionals in pharma, biotech, distribution (GDP), pharmacies, hospitals, laboratories and medical device manufacturing. Technical managers responsible for stability chambers, cold rooms and ULT freezers can also use it to review their documentation.

The questions are tailored to warehouses (15–25 °C), cold rooms (2–8 °C), freezer rooms (−25 °C), refrigerators, freezers, stability chambers and ULT freezers (−80 °C). For each type, you only see questions relevant to that room or unit, including type-specific topics such as defrost cycles, seasonal mapping, ICH conditions or backup systems.

Allow about 5 to 10 minutes. You answer a few yes-or-no questions in each section. At the end, your audit report is ready with supporting notes for every question and practical recommendations for any gaps.

The report (PDF, approximately 6–8 pages) includes a cover page with the overall score and readiness indicator, followed by a detailed section-by-section review with supporting notes for each question. Where you answer no, you receive specific recommendations to close the gap. The report ends with a consolidated action list grouped by topic. You can share it internally with QA or use it as input for your own change control or CAPA process.

Your answers and contact details are used to generate your audit report and send it to you by email. We store the data securely and do not share it with third parties. See our privacy policy for full details on data handling and retention periods.

Yes. Based on your report, you can request a free consultation. We can review the open points with you, help prioritise actions and support you with remapping, protocol or documentation updates, or an external pre-audit if needed. Contact us via our contact page.