Description
Both internal and external GMP audits/inspections are a key requirement of Quality Management systems across medical device, biotechnology and pharmaceutical industries. Achieving a successful audit outcome is essential to maintaining an effective QMS and fundamental to retaining manufacturing licenses. In order to align systems and processes to ensure compliance and favorable audit outcomes personnel must understand the auditor focus and methodologies. This book summarises key areas that inspections cover along typical areas of risk and concern. The following chapters are included: Introduction to Good Manufacturing Preparation for Audits Inspection of Quality Systems During the Inspection Biotechnology Inspection Guide Medical Device Inspection Guide Drugs Inspection Guide Computerised Systems Inspection Guide CHAPTER 8 Computerised Systems Inspection Guide Introduction94 Hardware 94 Validation of Hardware96 Software98 Electronic Records and Signatures106 Electronic Records Verification Methods117
