Loading
Protocol authoring, execution and audit-ready dossiers covering DQ/IQ/OQ/PQ, cleaning validation and computer system validation.
Equipment qualification is only half of a regulatory submission. GentlemanPharmed's validation group authors and executes the process documentation that inspectors actually ask for, mapped to your site's Validation Master Plan and to the market you are filing in. We work to WHO-GMP, EU-GMP Annex 15 and USFDA process validation guidance, covering the full lifecycle from user requirement specification through continued process verification. Where a machine of ours is involved we cross-reference the qualification dossier directly, so there is no gap between equipment and process records.
User requirement specifications, functional and design specifications, traceability matrices, and continued process verification plans authored as one coherent set.
Worst-case product bracketing, MACO calculations, swab and rinse recovery studies, and analytical method rationale for shared-equipment trains.
21 CFR Part 11 and EU-GMP Annex 11 assessments covering audit trails, electronic signatures, user access control and data integrity (ALCOA+).
Pre-audit gap assessment against the standard your inspector will apply, with remediation tracked to closure.
Review of existing documentation against the target regulatory standard, producing a prioritised remediation register.
Site-specific protocols drafted against your Validation Master Plan, with acceptance criteria agreed before execution begins.
Witnessed execution with contemporaneous raw data capture, deviation logging and impact assessment.
Approved summary reports, traceability matrix and the complete indexed dossier handed over in both bound and electronic form.
Contact our team to discuss your service requirements and get a tailored quote.