SOPs, instructions, VMP and QMS document infrastructure — the written evidence of your quality system that stands up to inspection.
Preparation and revision of standard operating procedures, instructions and forms in line with current regulations.
Setting up a comprehensive quality management system infrastructure: document hierarchy, control systems and archiving.
Comprehensive risk assessment and prioritisation using FMEA, Ishikawa and risk matrix methods.
Preparing and updating a site-wide VMP and managing it as a living document.
A compliant change control procedure, assessment system and impact analysis infrastructure.
Support with preparing and updating the Site Master File for regulatory authorities.
Let's screen your existing documents with a gap analysis and clean up missing, redundant or overlapping topics.