Organizations in the life sciences industries must comply with the Computer System Validation (CSV) requirement that is issued from the FDA. The regulation mandates that companies in the life sciences industries have the specific controls and procedures in place to consistently produce results that meet its predetermined specification and quality attributes.
YASH brings a thorough understanding of this requirement and a practical risk-based approach to CSV and helps enable life science customers to meet global regulatory requirements, eliminating the GxP compliance risk. Our highly qualified and experienced consultants have real-world domain experience and have the right capabilities and tools to tackle ERP, manufacturing, laboratory, and clinical systems.
YASH’s CSV compliance services include:
CSV Compliance Services
Details of Services
|End to End Computer System Validation Services||Offered for any GxP sensitive computer system implementation, development, upgrade, and rollout project, services include: IQ, OQ, PQ with all other validation deliverables as per GAMP 5 standards. The services also include GxP Control Mitigation and 21 CFR Part 11 Analysis. YASH has standard approved CSV templates, processes and procedures, tools, reusable assets like User Requirements, Functional Requirements, etc. which helps reduce the CSV timelines.|
|21 CFR Part 11 Analysis and System Remediation||21 CFR Part 11 Analysis and Remediation is conducted as part of CSV end to end validation services or separately if 21 CFR Part 11 compliance is not implemented. 21 CFR Part 11 is also referred to as Electronic Records and Signatures and is mandatory for FDA regulated industry to comply.|
|GxP Risk Assessment and Control Mitigation||GxP Risk Assessment and Control Mitigation is conducted as part of CSV end to end validation services or separately if GxP Controls are not implemented or found missing during CSV audit. YASH has a robust GxP Risk Assessment Tool to enable, track and incorporate GxP Control Requirement in the GxP System.|
|Validation Testing Services||Validation Testing Services is an independent service where YASH provides functional resources with the relevant functional and CSV expertise to execute validation testing of GxP System and ensure objective evidence in form of proper documented evidence adhering to Good Testing and Documentation Best Practices. Validation Testing Services can be offered as part of CSV end to end services or a separate service and can also be executed 100% offshore.|
|Quality Assurance Review||Quality Assurance (QA) Review service is an independent service offering for review of all Validation deliverables. QA Review service can also be offered during Validation Testing with independence of Review maintained if YASH is also performing Validation Testing Services.|
|CSV Audits||CSV Audit is conducted periodically preferably annually to check the compliance
health of Validated and Non Validated GxP System. YASH will conduct
the CSV Audit and generate a CSV Audit report along with mitigating
steps and procedures. YASH can also help customers to close on compliance
Our industry demands continuous product innovation, cost control, and compliance to various regulatory and statutory requirements. We wanted to seamlessly integrate various business processes across different business functions from R&D to manufacturing to delivery