Computer System Validation : Life Science Solutions
Should you really have access to that? Not many people want to ask that question. Raland Technologies does because the Code of Federal Regulations Section 21, Part 11 (21 CFR Part 11), set forth by the FDA, lays out guidelines pertaining to computer based system operations.
In order to ensure our clients are getting the best performance of their resources and complying with industry regulations Raland Technologies developed PAR planning (Planning/Action/Results). Beginning with a Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis we set out a road map that determines action steps that are appropriate, sensible, achievable, and practical and still yield the results our clients want and need.
Planning - SWOT analysis of 21 CFR Part 11 Compliance
- Limiting system access to authorized individuals
- Use of operational system checks
- Use of authority checks
- Use of device checks
- Determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform there assigned tasks
- Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
- Appropriate controls over systems documentation
- Controls for open systems corresponding to controls for closed systems bulleted above
- Requirements related to electronic signatures
Action - Technical Process to Achieving Results
- 21CFR Part 11 Assessments and Remediation Planning
- Regulatory Compliance Reviews
- Vendor Audits
- Validation Plans
- System Acceptance Tests
- Qualification Protocols
- Project Management
- Development of SOPs
- Training
- IT/IS Audits
- Software Development
- System Design Specifications
- System Security Consulting
Results - Fully Functional Systems Developed, Implement and Validated
- Enterprise Resource Planning (ERP) - SAP, Oracle, JD Edwards
- Programmable Logic Controllers (PLCs)
- Supervisory Control and Data Acquisition (SCADA)
- Building Management/Automation System (BMS/BAS)
- Process Automation/Control Systems (PAS/PCS)
- Laboratory Management Systems (LIMS)
- Material and Resources Planning (MRPII)
- Preventive Maintenance Management Systems
- Calibration Management Systems
- Laboratory Data Acquisition
- Warehouse Automation Systems