Regulatory Compliance & Validation

Critical Systems conducts detailed reviews, assess risks and challenges and formulate effective plans to manage regulatory compliance throughout the lifetime of a project.

We can provide a holistic approach to systems, policies and strategies. We undertake regulatory compliance assessments and gap analyses, offer training and provide validation services and regulatory audit support. We maintain close contact with current regulatory trends emanating from US FDA, the EMeA, and European national authorities such as the UKs MHRA.

Our offer includes:

• Good Manufacturing Practice (GMP) auditing
• Operator exposure and containment
• Validation and quality master planning
• Risk assessment and management
• Quality system design, implementation and maintenance

Integrated Validation practices

Integrated validation practice has evolved to ensure affordable quality and accountability. We can provide the style of validation to meet the need, whether that be “Full arms-length independent validation”, “Integrated Commissioning and Qualification”, or ASTM 2500 supported “Specification, Design, and Verification”.

Our validation philosophy is based on:

• A pragmatic approach to validation based on our knowledge, and that of our clients, of patient risk, current regulatory requirements and forthcoming expectations
• The integration of validation activities within the overall project programme and focus at each stage of the validation study on the total project requirements
• The use of risk-based compliance tools and criticality analysis techniques to manage the extent of validation
• The availability of fully experienced, self-starting validation engineers and scientists from our in-house pool, most of whom are recruited directly from the pharmaceutical and biotechnology industries
• The application of robust project management that is focused on project delivery and progress tracking tools to ensure delivery cost effectively, on time and to budget

Validation services

A complete validation solution is available, either ‘stand-alone’ or as part of an integrated project service, encompassing the following essential elements:

• Validation master plans
• Criticality and risk assessments
• Training for validation
• Validation team development
• Design reviews and qualification
• Protocol preparation (DQ, FAT, IQ, OQ, PQ, computer systems validation)
• Practical testing (FAT, IQ, OQ, PQ, CSV)
• Cleaning validation
• Process validation
• Review and audit of validation studies
• Document management
• Evaluation and reporting of results, and progression of deviations
• Inspection and test plans
• Supplier auditing
• Construction QA and QC
• Commissioning plans
• Engineering turnover packages
• Maintenance management
• Supervision and management of client, vendor and subcontractor staff

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