Validation is a process of establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a productmeeting its predetermined specifications and quality attributes.
Further, it also establishes that the facility is meeting current good practice in Manufacturing, documentation, laboratory and Clinical settings per the guidelines that are set for the industry by concerned regulatory bodiesfor any process impacting GxP and SOX requirements
Validation is an applied skill which is a combination of below core skills:
- Analytical Skills which involves Creative Thinking, Decision Making, Problem Solving and System Thinking
- Behavioural Characteristics which involves Ethics, Personal Organization and trustworthiness
- Business Knowledge which involves Industry Knowledge, Organizational Knowledge and Solution knowledge
- Communication Skills which involves Oral, Teaching and Written communication
- Interaction Skills which involves negotiation, leadership & Influencing and Team work
Below listed are the key concepts required in validation at a minimum.
- 21 CFR Part 11, 210, 211, 50, 58, 820 Requirements knowledge
- System/software Development Life cycle (SDLC)
- Validation Types
- Validation Approaches
- Validation Areas
- GAMP Principles
- Requirements Gathering
- Document Controlling
- Deviation Management
- Risk Management
- Change Management
- Technical Writing
Validation relies on documented evidence and two key documents are Test scripts and Standard Operating Procedure which are the proof that a process was validated and is acceptable for usage.
Software Validation is ensuring that the software functions per the business process and has no impact on patient safety, product quality and data integrity, software validation is performed under the framework GAMP (Good Automated Manufacturing Process).
After the above steps are successfully completed the system is then released to users i.e the system is Live, once the system is Live for any issues/enhancements all changes are handled via change management process.
Equipment Validation is ensuring that the equipment layout and design avoids any cross contamination, minimize the risk for errors, is safe to the product and he/she uses it and has no impact on patient safety, product quality and data integrity.
After the above steps are successfully completed the equipment is then released to users i.e., the equipment is ready for Use, before using any equipment baseline calibration of the equipment must be completed. once the equipment calibration is complete and approved by Quality then it is in use, for any issues/enhancements all changes are handled via change management process.