Commissioning, validation and training

Our dedicated CQV professionals bring wide-and-deep knowledge of the entire validation lifecycle (VLC), having supported clients from all major sectors within the Life Sciences industry. We guide you in the selection of the right validation strategy and fully supports all your tactical, hands-on deliverables, from protocol preparation, through “floor executions” and data analysis.

– Our C80 engineers also possess the required attention to details, and knowledge/mindset in cGMPs and GLP to successfully execute the qualification of your manufacturing and laboratory facilities and equipment, your utilities, and your systems, following both the traditional and leverage approaches to C&Q.

• Preparation of the early validation lifecycle deliverables, from the user requirement specifications (URS) to the design qualification (DQ) documents.

• Preparation and execution of commissioning testing protocols (e.g. factory acceptance tests, site acceptance tests, installation verification, etc.).

• Guidance and preparation of Quality Risk Assessments for the execution of “enhanced commissioning” strategies

• Preparation and execution of validation plans, and installation and operational qualification (I0Q) protocols; preparation of validation summary reports.

• Assessment of commissioning data and preparation of leveraged 10Q reports.

• Preparation and execution of Computer System Validation (CS) and Software Validation protocols: preparation of summary reports

• Qualification of Laboratory Equipment and Instrumentation

• Data Integrity Assessments.