Validation services assist customers to guarantee successful regulation compliance. Quality experts can set up process risk analysis, create validation master and/or test plans, provide Installation Qualification (IQ), Operational Qualification (OQ) and performance qualification (PQ) protocols, provide on-site qualification tests, and bring assistance during FAT and SAT performance. Our customers are always held responsible for the final validation, and so Elan Software makes sure that a validation report is issued.
Elan and partner teams are available to assist with on-site integration and operational qualifications.
Validation services can include any of the following activities:
- Review customer QM systems with regard to computer systems validation
- List documents required and procedures to be used for their creation
- Set up a validation plan and associated validation documents
- Set up a risk analysis and description of business processes to be automated
- Review the risk analysis, considering cGxP relevance of the respective business processes
- List standard operating procedures required for cGxP-compliant operation of the XFP-MES solutions and for system administration
- Set up test plans and reports for IQ/OQ/PQ