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Latest articles

• Compliance3 Nov 2026 · 7 min read

  AI in GMP systems: what the EU GMP draft Annex 22 means for your QMS and LIMS

  What the EU GMP draft Annex 22 on artificial intelligence expects, what it means for AI in your QMS, LIMS and eBMR, and the questions to ask vendors.

  • Annex 22 is still a draft — published for consultation in July 2025 and not yet in force.
  • It treats AI as a computerised-system function: defined intended use, independent testing, acceptance criteria and human oversight.
  • Annex 11, Part 11, data integrity and ALCOA+ still apply to anything an AI touches.

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• Buying guide29 Oct 2026 · 8 min read

  Choosing a pharma QMS: 15 questions to ask vendors

  A vendor-neutral pharma QMS software comparison checklist: 15 questions on compliance, workflows, validation, data, hosting and cost to ask before you buy.

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• Compliance22 Oct 2026 · 8 min read

  Data integrity findings in MHRA and FDA inspections — and how to avoid them

  Common failures behind data integrity warning letters and MHRA findings — shared logins, deleted data, unreviewed audit trails — and how to prevent them.

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• Quality15 Oct 2026 · 8 min read

  Annual Product Quality Review (APQR/PQR): what to include

  APQR pharma guide: what EU GMP, FDA and ICH Q7 expect in an annual product quality review, a section-by-section checklist and how to reach conclusions.

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• Validation8 Oct 2026 · 7 min read

  Computer software assurance (CSA) vs CSV: what changes for pharma

  CSA vs CSV explained for pharma: what computer software assurance changes, what stays the same under Part 11 and Annex 11, and how to adopt it without risk.

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• Laboratory3 Oct 2026 · 9 min read

  How to run an OOS investigation (Phase I / Phase II)

  A step-by-step OOS investigation procedure: Phase I lab checks, Phase II full-scale investigation, retesting and resampling rules, CAPA and common pitfalls.

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• Compliance1 Oct 2026 · 8 min read

  ALCOA+ explained with examples from the QC lab

  ALCOA+ examples from the QC lab: what each data integrity principle means at the bench, the failures inspectors find and the controls that prevent them.

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• Manufacturing28 Sep 2026 · 9 min read

  Paper BMR vs eBMR: cost, compliance and a migration roadmap

  Moving from paper to electronic batch records: where paper BMRs cost you, what eBMR changes for compliance and review, and a phased migration roadmap.

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• Quality24 Sep 2026 · 8 min read

  CAPA effectiveness checks that survive an inspection

  How to design a CAPA effectiveness check that convinces an inspector: measurable criteria, the right time window, real data and a decision when it fails.

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