Policy and Procedure Development
Policy and Procedure Development
We can develop a complete suite of Policies and Procedures to assist you in documenting the System Life Cycle and validation process. Adhering to these procedures helps you meet the regulatory requirements for CSV. Logica has been delivering consultants to assist the life science industry execute the following tasks:
- Software Quality Assurance Plan
- User Requirements Specifications
- Development of qualification protocols (IQ and OQ)
- Planning of validation activities
- Functional Requirements Specification
- Risk Analysis
- Vendor Assessment and Evaluation
- System Design Specification
- Design Reviews
- Code Reviews
- Coding Standards
- Software Revision Control
- Validation Test Plan
- Integration Test
- System Test
- Acceptance Test (FAT & SAT)
- Installation Qualification
- Operational Qualification
- Validation Summary Report
- Security Requirements
- Change Control
- Disaster Recovery Plan
- Archival/Backup Procedures
- Operator Manual & Training
- Preventive Maintenance Procedures
- System Audit Procedures
- System Retirement Plan
- SOP review and development
- Logica Life Science also supports these life-cycle activities:
- Project management
- System implementation planning
- Configuration management
- System start-up and check-out
- Trouble-shooting, debugging and problem follow-up
Documentation review
Audits/gap analyses of existing validation packages Logica executes projects using accepted guideline documents. When systems are delivered to the life science industry, GAMP and newly released Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Validation, are used for project execution. GAMP is merged into the general Logica project model: ‘Ratten’, which is used for all projects (also for non-Life Science clients). The GAMP V-model is utilized in all projects executed in the Life Science Industry. CSV Training We can help you implement CSV procedures and train your staff in accordance with FDA regulations. This helps insure that conformance to these regulations continues to be met as your company grows. Well-educated and knowledgeable staffs become your best defence by serving as a preventive measure against FDA non-compliance