An effective Quality Management System is underpinned by good documentation. We can provide reviews and gap analysis of your documentation by comparison with current regulatory requirements and best practices.

We can provide a complete suite of policies, guidance documents and SOPs tailored to suit your entire business or provide individual SOPs for specific systems.

We have template SOPs for Quality Systems including risk management, data integrity, change control, complaints handling, deviations/CAPAs and Validation/Qualification.

We can provide Excel spreadsheets to trend your data and create presentations for status reviews.

Recent examples of services provided include:

Creation of a full suite of Policies and SOPs for a solid dose manufacturing site.

User Requirement Specifications for a clean room facility and HVAC system, fridges and freezers.

Validation Master Plan and a suite of SOPs for validation.

Qualification protocols for HVAC systems, temperature mapping studies and temperature controlled transport systems.

Complete upgrade of the Quality Management System within a testing laboratory.