Data reliability, traceability and digital system integration — structures that meet the core expectations of modern GMP inspections.
Setting up and assessing data reliability, traceability and record management systems in line with ALCOA+ principles.
Review of electronic system audit trails, design of periodic review programmes and CAPA integration.
A risk-based CSV approach: GAMP 5 methodology, verification protocols and preparation of the document package.
Quality and validation support for eQMS, LIMS, MES and other digital platform implementations.
EU GMP — Computerised Systems. Requirements for electronic records, verification and data integrity.
FDA — the federal regulatory standard for electronic records and electronic signatures.
Attributable, Legible, Contemporaneous, Original, Accurate — the core principles of data integrity.
ISPE methodology and categorisation framework for risk-based computerised system validation.
Data integrity requirements and inspection expectations under GMP guidance.
A one-day assessment that delivers a map of your current state and a prioritised action plan.