Pharmasight — AI in pharma, built to survive the audit. https://www.pharmasight.tech/ Pharmasight is an AI consultancy for pharmaceutical and life-sciences companies. We design, validate and operate AI systems across discovery, clinical, regulatory, manufacturing, commercial and post-market — inside GxP. en-gb Sun, 30 Aug 2026 09:00:00 GMT How to Validate a Non-Deterministic LLM Without Pretending It Is Deterministic https://www.pharmasight.tech/blog/validate-llm-gxp-non-deterministic/ https://www.pharmasight.tech/blog/validate-llm-gxp-non-deterministic/ A test strategy for generative AI in GxP: qualify the deterministic guardrail layer, set abstention thresholds you can justify, and define revalidation triggers that actually fire. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Named Data Ownership Beats Any Agent https://www.pharmasight.tech/blog/rim-idmp-data-ownership/ https://www.pharmasight.tech/blog/rim-idmp-data-ownership/ Only 1 of 59 organisations is future-ready for RIM. The 2026 benchmark says named data accountability, not AI, predicts regulatory operations performance. Regulatory affairs Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Review by Exception After Twenty Years of Trying https://www.pharmasight.tech/blog/review-by-exception-electronic-batch-records/ https://www.pharmasight.tech/blog/review-by-exception-electronic-batch-records/ Pfizer cut EBR implementation cost per site by 80% and cycle times by over 11% without changing MES vendors. What actually moved, and what the regulations permit. Manufacturing, CMC & supply Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Your Validated Model Has a Retirement Date https://www.pharmasight.tech/blog/model-version-control-gxp-change-control/ https://www.pharmasight.tech/blog/model-version-control-gxp-change-control/ One deployment property decides whether a validated model is swapped underneath you — and what binding Annex 11 clause 10 actually requires when it happens. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Which GCP Clause Actually Governs Your Clinical AI Model https://www.pharmasight.tech/blog/ich-e6-r3-ai-governance-clauses/ https://www.pharmasight.tech/blog/ich-e6-r3-ai-governance-clauses/ ICH E6(R3) never names AI. The clauses that actually govern a clinical AI model, what binds on 30 August 2026 and what is still only draft. Clinical development Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Human Oversight Is a Control You Qualify, Not a Sentence in Your Risk Assessment https://www.pharmasight.tech/blog/human-in-the-loop-qualification-gxp/ https://www.pharmasight.tech/blog/human-in-the-loop-qualification-gxp/ Draft EU GMP Annex 22 makes human-in-the-loop a monitored manual process, not a risk-assessment sentence. What binds you now, what lapses, and the numbers to keep. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Costing a Health Authority Query Response Before You Automate It https://www.pharmasight.tech/blog/health-authority-query-response-automation-economics/ https://www.pharmasight.tech/blog/health-authority-query-response-automation-economics/ The only public HAQ benchmark surveyed 12 companies in 2022. Here is how to build a measured baseline instead, and what 200 hours per query really costs. Regulatory affairs Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Validating AI Under GxP in 2026: What Binds You, What Is Draft, What Inspectors Cite https://www.pharmasight.tech/blog/gxp-ai-validation/ https://www.pharmasight.tech/blog/gxp-ai-validation/ What actually binds AI systems under GxP on 30 August 2026: the 2011 Annex 11, 21 CFR 211.22(c), the EU AI Act, and which AI texts are still only drafts. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT FDA's First AI Warning Letter Cites a 1978 Rule https://www.pharmasight.tech/blog/fda-first-ai-warning-letter-purolea/ https://www.pharmasight.tech/blog/fda-first-ai-warning-letter-purolea/ FDA Warning Letter 320-26-58 to Purolea, dated 2 April 2026, cites 21 CFR 211.22(c) for unreviewed AI-generated GMP records. What it means for AI governance. Manufacturing, CMC & supply Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Your FDA Reviewer Switched Models https://www.pharmasight.tech/blog/fda-elsa-ai-model-switch-sponsors/ https://www.pharmasight.tech/blog/fda-elsa-ai-model-switch-sponsors/ FDA's Elsa moved off Claude in early 2026 under a federal directive. What a regulator-side model swap does to review consistency, and what sponsors should do. Regulatory affairs Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT FDA's Seven-Step AI Credibility Framework — And the Regulatory Operations AI It Never Covered https://www.pharmasight.tech/blog/fda-ai-credibility-framework-scope/ https://www.pharmasight.tech/blog/fda-ai-credibility-framework-scope/ What FDA's 7-step AI credibility assessment framework covers, what its scope section excludes, and which rules actually bind eCTD publishing and RIM AI. Regulatory affairs Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT What EMA Permits When AI Drafts Your Product Information https://www.pharmasight.tech/blog/ema-ai-drafted-smpc-labelling-epi/ https://www.pharmasight.tech/blog/ema-ai-drafted-smpc-labelling-epi/ EMA section 2.3.5 permits AI-drafted SmPC, labelling and leaflets under close human supervision and a factual and syntactic quality review. What that takes. Regulatory affairs Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT eCTD 4.0 in Japan, Europe and America — and Why Publishing Should Stay Deterministic https://www.pharmasight.tech/blog/ectd-v4-timelines-publishing-automation/ https://www.pharmasight.tech/blog/ectd-v4-timelines-publishing-automation/ PMDA moved to eCTD v4.0 in April 2026, EMA opened optional use in December 2025, FDA has set no date. What that means for publishing automation. Regulatory affairs Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Serialisation Proves Where a Package Went, Not Whether the Next One Ships https://www.pharmasight.tech/blog/dscsa-data-drug-shortage-prediction/ https://www.pharmasight.tech/blog/dscsa-data-drug-shortage-prediction/ DSCSA serialisation data records custody, not capacity. Why shortage-prediction models miss, what EPCIS exception management is genuinely good for, and the 2026 dates that moved. Manufacturing, CMC & supply Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Digital Twins Cannot Release Your Batch https://www.pharmasight.tech/blog/digital-twin-real-time-release-211-110/ https://www.pharmasight.tech/blog/digital-twin-real-time-release-211-110/ FDA's January 2025 draft on 21 CFR 211.110 permits in-line measurement but rules out control strategies relying solely on process models. Manufacturing, CMC & supply Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Computer Software Assurance Is Device Guidance — Cite It for a Drug System and Fail https://www.pharmasight.tech/blog/csa-vs-csv-drug-sponsors/ https://www.pharmasight.tech/blog/csa-vs-csv-drug-sponsors/ FDA's February 2026 CSA guidance covers device production and QMS software under 21 CFR 820. What binds drug sponsors instead, and when the boundary moves. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT EU GMP Annex 22, Clause by Clause https://www.pharmasight.tech/blog/annex-22-requirements-clause-by-clause/ https://www.pharmasight.tech/blog/annex-22-requirements-clause-by-clause/ A clause-by-clause reading of draft EU GMP Annex 22: acceptance criteria, test data, independency, explainability and operation, and what each costs. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT EU GMP Annex 22: What the AI Annex Actually Says https://www.pharmasight.tech/blog/annex-22-artificial-intelligence-gmp/ https://www.pharmasight.tech/blog/annex-22-artificial-intelligence-gmp/ Draft EU GMP Annex 22 permits only static, deterministic AI models in critical GMP applications and excludes generative AI. What it requires, its status in 2026, and what to do now. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Nineteen Pages, Seventeen Chapters: The Annex 11 Revision Clauses That Cost Money https://www.pharmasight.tech/blog/annex-11-revision-cost-clauses/ https://www.pharmasight.tech/blog/annex-11-revision-cost-clauses/ The July 2025 draft Annex 11 runs to 19 pages and 17 sections. Clauses 7.5, 12.6, 12.8 and 9.8 are the ones with a budget attached. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Nine Contract Clauses Your AI Vendor Will Refuse to Sign https://www.pharmasight.tech/blog/ai-vendor-qualification-annex-11-contracts/ https://www.pharmasight.tech/blog/ai-vendor-qualification-annex-11-contracts/ Draft EU GMP Annex 11 clause 7.5 sets out nine contract contents for GxP service providers. Which ones a hosted LLM API can meet in 2026, and which it cannot. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Ninety-Seven Percent Faster, Seventy Percent Complete https://www.pharmasight.tech/blog/ai-regulatory-writing-autoind-quality/ https://www.pharmasight.tech/blog/ai-regulatory-writing-autoind-quality/ The Weave–Takeda AutoIND preprint: 18,870 pages drafted in 3.7 hours, 69.58% quality, emphasis at 6.7%, and a 100% GLP omission rate. Regulatory affairs Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT What Regulators Have Actually Approved, Cited and Refused in AI-Enabled Manufacturing https://www.pharmasight.tech/blog/ai-pharmaceutical-manufacturing-regulatory-reality/ https://www.pharmasight.tech/blog/ai-pharmaceutical-manufacturing-regulatory-reality/ FDA has accepted 191 emerging technology proposals since 2014 and just 9 involve AI or modelling. What regulators have approved, cited and refused, with dates. Manufacturing, CMC & supply Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Drift, Abstention and Audit Trails: The Operating Plan a Deployed GxP Model Needs https://www.pharmasight.tech/blog/ai-drift-monitoring-revalidation-gxp/ https://www.pharmasight.tech/blog/ai-drift-monitoring-revalidation-gxp/ Drift monitoring, abstention rates and audit trails for a deployed GxP model: the 6 signals, the metrics, and when a retest becomes mandatory. GxP, validation & assurance Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Why Adding Agents Makes Deviation Investigations Worse https://www.pharmasight.tech/blog/ai-deviation-investigation-multi-agent-risk/ https://www.pharmasight.tech/blog/ai-deviation-investigation-multi-agent-risk/ Controlled studies show multi-agent AI degrades sequential reasoning 39-70%. What that means for GMP deviation investigation, CAPA root cause and batch release. Manufacturing, CMC & supply Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT Every Disclosed AI Cycle-Time Number in Clinical Development, and What Each Measures https://www.pharmasight.tech/blog/ai-clinical-development-cycle-time-evidence/ https://www.pharmasight.tech/blog/ai-clinical-development-cycle-time-evidence/ Novo Nordisk 90%, AutoIND 97%, AstraZeneca 85%, Novartis 83-87%: what each AI clinical development number actually timed, and why none of them is time to approval. Clinical development Tareef Roustom Sun, 30 Aug 2026 09:00:00 GMT