Computer System Validation
Life Science services need to ensure their computer systems constantly meet the standard requirements of complex software protocol. The process involves the provisions for documented evidence that the current computer system is compliant with complex regulatory requirements. The computer system validation process involves the adoption of rigid verification methods to ensure the system can handle the requirements of specialized niche scientific software protocols.
DAC INFO is capable of handling the entire range of computer system validation activity, whether you have a simple PLC system or a complex ERP application. The validation process confirms effectively with documented directives that each installed application in the laboratory computer systems fulfills its intended purpose. We are competent at handling specialized software system requirements in pharmaceuticals, biotechnology, and medical device manufacturing protocols. The validation process guarantees the reliability, availability, and integrity of the business data in Life Science systems, establishing a proper workflow with intended results in each production cycle.
Our Computer System Validation services are available in four broad ranges.
- Planning and project initiation
- Evaluation of system requirements and design reviews
- Complete system verification
- Fluent system operation
The initial planning and project initiation protocol look into Gap assessments and Risk assessments to develop a Validation Master Plan (VMP). Once we have the blueprint of action, our specialists look into the details of evaluating system requirements. These services include URS (User Requirement Specification), FS (Functional Specification), DS (Design Specification), Design Review, and Supplier Audits.
The systems verification during computer system validation services further include Performance Qualification (PQ), Operational Qualification (OQ), Installation Qualification (IQ), Site Acceptance Testing (SAT), Factory Acceptance Testing (FAT), Integration Testing, Unit Testing, and Vendor Documentation. We handle system requirements irrespective of the size. Clients benefit from document development and execution protocols in both software and hardware systems.
Finally, the team at DAC INFO provides ongoing system support and training for computer system validation. The computer system validation services include data backup and recovery, data archiving arrangements, disaster recovery, continuity planning, system upgrades, periodic system operation reviews, configuration management, and best practices training. Ensure your computer system is at par with the evolved standards of advanced Life Sciences requirements. In addition, we also handle the requirements of EMS (Environment Monitoring Systems), BMS (Building Management Systems), Laboratory Management Systems, ERP, and Quality Management Systems.