Another factor to think upon is the quality of validation and time for execution..
The above stated approach delivers Quality in all the deliverables and also deliver within the specified timeline.
All these approaches are tested at root and then the resources are allocated which further reduces time of execution and there by controlling costs as well as activity.
Also, increased confidence on the data and the process.
Current pain areas of Organizations:
- Initial discussion with the customer team
- Creating awareness by way of a presentation and discussion session for
- requirements identification and
- validation planning.
- identifying exact timelines for the completion activity, documentation and verification and
a debate on protocol with the technical team to plan the activity
where the customer is ensured complete peace of mind and confidence about the implementation of the validation. This also significantly reduces the Validation Time and Controls Costs.
Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application. System requirements are gathered and documented in the system definition phase. System definition artifacts that reflect these requirements can include, but are not limited to, the following:
Typically CSV is becoming mandatory with those systems that are dedicated or operated with..
- User Requirements Specification: Details each feature of the system.
- Hardware Requirements Specification: Minimum hardware required to support the system.
- Electronic Document Management Systems like– Documentum, FileNet
- Training and Laboratory Management Software (TMS/LMS)
- Laboratory Instrumentation and Software (LIS)
- Manufacturing Execution Systems (MES)
- Laboratory Information Management System (LIMS)
- Adverse Events Reporting Systems (AERS)
- SAP ERP Systems that are mostly used in SCM(Supply Chain Management), Batch record generation, Quality
- control and assurance master file holding systems, Leave management, Safety and Health record management etc.
- Compliant Handling Systems
- Corrective and Preventive Action Systems (CAPA)
The above is a comprehensive but not a detailed list and CSV is mandatorily asked by many areas where the regulators feel concern over security regarding data generation and modification.
Computer System Validation Deliverables
- Validation plan
- System Impact Assessment
- Requirements specifications
- System configuration specifications
- Test plan
- Testing and Reports for
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)
- Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11)
- Traceability matrix
- Quality assurance review
- Validation summary report
- Review of Standard Operating Procedures (SOPs) and Training
The list is a comprehensive and may be amended and Annexure & documents can add up based on the category of the organization and based on the validation planner.
All these fulfill the required typical model of GAMP 5.