Validation & Compliance

We provide specialised validation services (both document creation and execution) and the project management of validation activities of equipment, facilities, and utilities.

We can assist clients to ensure that the introduction of processes and process equipment is undertaken in such a manner that it can be fully validated in accordance with regulatory requirements.

We can execute the client’s own protocols or we can offer the services of our team of specialist to write and execute documentation according to full Good Documentation Practices: We are happy to work flexibly with clients; you only pay for what you want!

• Risk Assessments
• GMP review, gap analysis and preparation of remediation plans.
• PIA readiness preparation
• Design Qualification
• Master validation plans
• Validation Plans
• Validation protocols (IQ / OQ)
• Process validation
• Validation reports
• Re-validation plans and protocols
• Retrospective validation
• FAT and SAT acceptance protocols and testing

We specialise in working with clients to ensure that both processes and equipment are introduced in a compliant manner that will fully meet validation and EU & FDA regulatory requirements. Part or full turnkey service.
Our protocols are individually created to ensure that they comply with client’s URS’s, standards and SOP’s and to the client’s timeframes even if the timelines are short.  We can help clients define appropriate acceptance criteria.

We offer full validation services associated with manufacturing projects as well as offer services to retrospectively validate existing manufacturing processes.

Our skilled personnel can work with your operations and quality groups to generate process validation protocols, facilitate execution, collate documentation, and generate reports.