Computer System Compliance Consultancy
We can help you to frame your Computerized System Compliance programs to suit your existing QMS documentation and making it an integral part of your quality documentation. We can assist in identifying broad strategies at corporate level and translating them into operational methodologies at plant level. We can help in preparing Validation Master Plans, Risk Assessment Strategies, Standardized Test Protocols and IT SOPs.
We can work with you in specifying, selecting, developing, implementing, validating and maintenance of computerized systems used in FDA compliant applications.
We utilize best practices of GAMP5, 21 CFR Part 11, EU Annx 11 to create a holistic and harmonized computerized system compliance framework.
- Create systems and framework for insulating against increased regulatory expectations
- Making Client always 'audit-ready' for CS Compliance
- Creating and coaching internal SME to handle audits and new technological implementation
- Optimizing resources to increase efficiency and consistency in CS practices by reducing repetitive and duplicate activities, documentation, and harmonising consistent practices across all units
- Creating a Dashboard for overall Data Integrity
- Overall IT governance program with policies, procedures and infrastructure optimization