GMP Auditing and Subject Matter Expertise
ValiCore ADVISORS conducts independent GMP audits for manufacturers and marketing authorisation holders — at their suppliers, on their behalf, and at their own sites. Three types: audits of software, SaaS and IT service suppliers under Annex 11 and Chapter 7; mock inspections and self-inspections under Chapter 9; audits of contract manufacturers and contract laboratories with qualified partner auditors. Where an audit reaches into automation, computerised systems and data integrity, or AI-assisted manufacturing, our subject-matter experts join the audit team. Findings are graded against the regulation, with the evidence attached.
What we do
- independent auditing and subject-matter expertise -
Independent third-party auditing
Third-party audits are foreseen by EU GMP: Chapter 7 for outsourced activities, Annex 11 §3 for suppliers and service providers of computerised systems, and Chapter 9 for independent self-inspections by external experts. The regulated company commissions the audit; the report is issued to it and becomes part of its records.
Our audits cover software, SaaS and IT service providers, automation and engineering suppliers, contract manufacturers of small-molecule and biological drug products, contract laboratories, and your own sites. Each audit is scoped in writing to the applicable chapter, annex or guideline and closes with a structured report, a risk classification of findings and defined CAPA requirements.
Subject-matter expertise inside the audit
ValiCore ADVISORS brings subject-matter expertise in the technical disciplines that underpin GMP compliance in modern manufacturing: process automation and control, digitalisation, and computerised-system validation and data integrity. Our specialists have worked in production, automation and IT/digital environments.
This expertise is deployed primarily inside our audits, giving targeted depth where a finding, system or process demands it, and is also available as a focused stand-alone assessment or embedded project support. Audit organisations and consulting firms can bring it into their own audits — see below.
Three types of audit
Computerised-System and IT Supplier Audits
Annex 11 §3 and Chapter 7 require the regulated company to assess the suppliers and service providers of its computerised systems. We conduct these audits on your behalf, led by our own certified GMP auditor, on site or remote — at software vendors, SaaS and cloud platforms, IT service providers, system integrators and automation suppliers whose products or services touch GMP records or decisions.
- Quality system, development, testing and release practices — GAMP 5 supplier assessment
- Validation support, documentation and change control provided to you — Annex 11 §3, §4, §10
- Data integrity, security, backup and continuity of hosted services — Annex 11 §7, §12, §16
- AI-assisted and data-driven functions — model control and change (draft Annex 22)
Mock Inspections & Self-Inspections
Chapter 9 provides for independent audits by external experts as part of a manufacturer's self-inspection programme. We inspect your site the way an authority inspector will — documentation, processes, systems and personnel — with particular depth in computerised systems, data integrity and automation. You see your site as the inspector will see it, with time to close gaps, and the report is written so that it stands as a self-inspection record.
- Full-scope or system-specific inspection simulation
- Data integrity and computerised-system inspection readiness (Annex 11, Part 11)
- Personnel interview preparation
- For-cause reviews after data-integrity or system events — root cause, systemic risk, CAPA definition
- Prioritised remediation roadmap
CMO & Contract Laboratory Audits
Before a contract manufacturer or contract laboratory enters your approved supplier list, or when a deviation, complaint or regulatory signal raises questions about one already on it, we audit it on your behalf under Chapter 7 — with particular depth where the audit reaches into electronic batch records, laboratory systems and data integrity.
- Contract manufacturers — drug product (Part I, Chapters 1–9) and biological drug substance (Part II and Annex 2), Chapter 7
- Contract laboratories — Chapter 6 (Quality Control), Chapter 7, OOS handling
- Electronic batch records, MES, LIMS and CDS — Annex 11, data integrity
- For-cause audits — focused scope, short lead time, CAPA requirements and response evaluation
Subject Matter Expertise - brought into the audit.
Complex audit topics need more than a generalist auditor. When a GMP audit reaches into automation layers, digital systems, or data integrity, our auditors are joined by subject-matter experts who examine those areas in the depth they demand. The domains below are the specialist capabilities we bring into targeted audits — within any of our audit services, or as a focused stand-alone assessment.
Process Automation & Control
Audit support on automated manufacturing and process control systems — SCADA, DCS, PLC and MES environments, as well as model-based and data-driven control systems. We support the audit team in assessing GMP alignment, alarm management, audit trail integrity and electronic batch
record (EBR) configuration against EU GMP Annex 11 and GAMP 5.
Digitalisation & GMP Compliance
Expert audit support for the digitisation, digitalisation and digital transformation of regulated manufacturing. Whatever shape an initiative takes — new platforms, connected shop-floor systems, data-driven or AI-assisted processes — we support the audit team in assessing its GMP impact, validation approach, and change control, so that findings reflect how digital manufacturing actually works.
CSV / CSA & Data Integrity
Computerised systems sit squarely within GMP audit scope — any system touching GMP records must be validated (21 CFR Part 11, EU GMP Annex 11). We support audit teams in assessing the validated state: system
inventory and impact classification, a defensible risk-based CSV/CSA rationale, COTS / SaaS supplier assessment, IQ/OQ/PQ traceability, data integrity, and periodic review — down to proving a single batch record's system end-to-end. Audits of software, SaaS and IT service suppliers are led by our own certified GMP auditor; in audits led by others we join as embedded specialists in modern software and AI systems and their compliance.
For audit organisations and consulting firms
When an audit reaches into an MES, a LIMS, a cloud QMS, automation layers or an AI-assisted process, ValiCore ADVISORS provides the specialist auditor for that part of the scope — embedded in your audit team, under your procedures, with the findings written into your report. Engaged per audit, by GMP audit bodies, consulting firms and the audit departments of manufacturers and marketing authorisation holders.
