System validation projects must be fully compliant with GxP standards and regulations, BPV provides CSV validation expertise ensuring that computerised systems are safe, reliable, and comply with regulatory requirements. Validation is mainly carried out by applying a GAMP 5 methodology (Good Automated Manufacturing Practice 5).
COMPUTER SYSTEMS VALIDATION (CSV) SERVICES
Professional CSV Service Engineers in the UK and IE
As computer system validation service providers, BPV offers comprehensive CSV services to clients. Our services include the validation of the computer systems and software used in regulated industries, such as pharmaceutical manufacturing and life-science industries.
BPV’s CSV validation services are made to provide comprehensive support, testing, and preparation of all documentation during the project life-cycle, including system design, installation, and execution of all related processes. Our team of experts is dedicated to ensuring that your systems comply with all regulatory requirements and industry standards.
To ensure your computer systems and software are performing as intended, our CSV expertise includes:
Installation Qualification (IQ): This stage certifies the full set of installation activities for each software component. It includes details such as the version, date, and a listing of components. If required, migration tasks are also included.
Operational Qualification (OQ): This stage involves performing quality assurance (QA) testing on an independent QA test platform. The platform has an identical configuration and installation procedures to the ones used for the platform’s testing and development environments.
Performance Qualification (PQ): This stage involves simulating different use cases and environments to reduce customer issues. Performing PQ validation tests is essential in an environment where evolving regulations necessitate frequent code changes.
