PHARMA FDA- COMPUTER SYSTEMS VALIDATION
- Computer Systems facilitates the process control, monitoring in manufacturing areas as well as environment condition monitoring in storage areas.
- Computer Systems are used to create, modify, maintain, store, archive, retrieve, transmit the data.
- Any computer system used for above functionality in pharmaceutical industry must be validated as per GAMP 5 guidelines.
CSV following GAMP 5 guidelines ensures that :
- The users and suppliers work together to understand the individual's responsibility regarding validation.
- Documented assurance is provided to the user that the system is appropriate for intended purpose before actual use of system in process.
- Suppliers verifies the system to eliminate the avoidable defects in system being supplied.
- System supplied is as per specifications and regulatory requirements.
- Computer data is protected from unauthorized changes, access and losses.
Skytech Systems providing below services related to computer system validation
- Validation Master Plan
- Comprehensive GAP & RISK Analysis.
- Most appropriate & latest GAMP, 21 CFR Part 11, EU Annex 11 guideline based Compliance services for your new / legacy systems.
- Validate Building Management & Environment Control Systems
- Programmable Logic Control (PLC )
- Supervisory Control & Data Acquisition (SCADA) Systems
- Distributed Control Systems ( DCS ).
CSV-Services as per GAMP5-V Model
- Prepare User Requirement Specifications
- Perform Supplier Assessment
- Prepare Functional Requirement Specifications
- Perform Functional Risk Assessment
- Design Specifications & Configuration Specifications
- Validation Protocol
- Installation Qualification
- Operational Qualification
- Assessment for Compliance to 21 CFR part 11 and EU Annex 11 requirements for ER & ES
- Performance Qualification
- Validation Summary Report
- System Release Certificate , Traceability Matrix
- Periodic Review Report
- System Retirement Report
- Excel Sheet Validation
- Technical support during regulatory compliance audits as per customer requirements
- Training
COMPUTER SYSTEM VALIDATION SERVICES
- Validation Master Plan
- Comprehensive GAP Assessment & RISK Analysis.
- Prepare User Requirement Specifications
- Perform Supplier Assessment
- Prepare Functional Requirement Specifications
- Perform Functional Risk Assessment
- Design Specifications & Configuration Specifications
- Validation Protocol
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Validation Summary Report
- System Release Certificate , Traceability Matrix
- Periodic Review Report
- System Retirement Report
- Excel Sheet Validation
- Assessment for Compliance to 21 CFR part 11 and EU Annex 11 requirements for ER & ES
- Most appropriate & latest GAMP, 21 CFR Part 11, EU Annex 11 guidelines based Compliance Services for new / legacy systems.
- Technical support during regulatory compliance audits as per customer requirements
