Computer System Validation
The integrity of computerised systems is critical within the pharmaceutical, biotechnology and life sciences industries due to the potential impact on patient safety, product quality and data integrity.
Computerised Systems Validation (CSV) is a structured process designed to mitigate these risks by ensuring that a system meets applicable regulatory requirements, is fit for purpose and functions as intended.
At Scitech, we have extensive experience supporting pharmaceutical and biotechnology manufacturers, clinical research organisations, and laboratories with the design, implementation and validation of new computerised systems; ongoing activities associated with operational computerised systems, including change management and periodic compliance reviews; and retrospective activities bringing pre-existing systems into compliance.
We can assist with the full project life cycle, from understanding and documenting user requirements and writing project validation plans through to auditing suppliers, writing or reviewing design documentation, writing and executing test plans and protocols, and writing policies and procedures on CSV and data integrity. We use the GAMP 5 guide as a basis for many of our document templates and processes, risk management for example.
Our pragmatic, risk-based approach to all projects will ensure that we only undertake the activities that will add value; and our detailed understanding of the regulatory landscape will ensure that your computer systems are compliant with all of the applicable regulatory requirements (FDA, MHRA, EMA) providing you with the confidence that your computerised systems operate to the applicable GxP standards.
We have experience performing these activities on a wide variety of computerised systems, including:Read more
- We support qualification of new and upgraded IT infrastructure including servers (virtual and physical), firewalls and network hardware.
- We have expertise in the writing of design documentation and validation of PLC, SCADA and DCS based automation systems in R&D, Primary and Secondary manufacturing.
- We can support the validation of local and cloud-hosted applications including ERP, EMS and compliance management systems (documents, change controls, CAPAs etc.)
- We have extensive experience in the specification and validation of purified water, clean steam and WFI control systems.
- Packing lines. We can support the validation of vision systems including Optical Character Recognition, barcode labelling systems including label design and management.
- Laboratory systems. We have experts who can provide validation of computerised analytical equipment including spectrophotometers, plate readers and cell counters as well as validation of LIMS.