Computerised Systems Validation

Quality is the most crucial requirement in all pharmaceutical and healthcare industries. Medications must be produced with the utmost care and quality and IT systems are becoming essential for pharmaceutical plants as they control, support, and document processes.

Capabilities Expertise

Validation Master Plans (VMP)

User Requirements Specification

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Validation Summary Report (VSR)

Periodic Review

Validating computer and IT systems ensures that all applications function properly and comply with relevant regulatory requirements i.e., The FDA 21 CFR part 820.70, FDA, 21 CFR part 11.10, FDA, 21 CFR part 11, European Union Annex 11, and Good Automated Manufacturing Practice (GAMP) 5.

Other Validation Solutions

The term ‘Validation’ is broad in scope and reach. It may refer to a study demonstrating that a facility complies with relevant regulatory requirements, or it may refer to an exercise showing the qualification of a specific plant process against a particular standard, or it could relate to an investigation to confirm the test results of a flow monitoring system are accurate to within the required tolerances via a secondary testing regime.

Synertec is certified to ISO 9001 (Quality), ISO 14001 (Environment), and ISO 45001 (Occupational Health & Safety). We understand what it takes to develop and maintain compliant systems and to support our clients with their own performance and compliance requirements.

Our experience and knowledge are centred around a team of expert engineers and scientists who have a deep understanding of the technology and processes across a wide range of industries and have hands-on experience implementing compliant solutions for these industries.