VALIDATION OF COMPUTERIZED SYSTEMS (CSV)
Regulatory agencies such as the US FDA have established validation as a core requirement of
quality assurance for pharmaceutical manufacturers. In spite of guidance and industry
standards, many companies fail to develop an adequate validation program.
Validation is broadly applied across the organization to ensure that products, equipment,
processes, software and systems operate as designed and intended. Successful validation
practices bring together engineering, manufacturing, regulatory compliance, and quality
assurance to develop test solutions that are unique to each application. Developers of IT
applications must validate the product design to ensure that it meets the user's requirements.
Manufacturers of drugs must validate any process, including any associated equipment,
systems and software. Critical processes that must be validated include material handling,
assembly, chemical or biological processing, purification, testing, cleaning, packaging,
labeling, storage and distribution.
BioQuality ™ is experienced in the validation of many types of equipment, processes and systems
used in a wide variety of pharmaceutical and medical device applications. We use a risk-based
approach to validation that analyzes each risk for potential harm and likelihood of occurrence
in order to focus testing around the functions that are the most critical. To properly evaluate
these risks, our staff is comprised of engineers and scientists who understand the technical
functionality of the process. We work closely with each client to tailor validation projects to
their business and compliance needs.
Some of the key areas of Validation include:
- Computer System Validation (CSV)
- Validation of Automated Systems
- Validation of Equipments
- Process Validation
- Qualification of Infrastructure and Networks
- Risk-based Validation Strategies
- Supplier audits to leverage already documented V&V
- SOP Systems Development
- On-site Validation Management
- On-site Validation Execution
- Final Report Preparation
- Vendor Audits
- FDA Liaison
- Revalidation
- Validation Documentation
- User Requirements
- Functional Requirements
- Master Validation Plan
- System Validation Plans (VP)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Traceability Matrix (TM)
- Validation Reports
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