Computerized Systems Validation
- Prepare Computer System Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report.
- Perform high level risk assessment to compliant GxP computerized systems.
- Assess the FDA CFR Part11 and Annex 11 requirements.
- Develop a Validation Plan that is appropriate for the system risk level.
- Work with your team to develop user requirements and functional specifications.
- Develop Qualification and Testing Protocols (IQ, OQ, PQ)
- Execute the Validation Protocols and provide supporting test documentation
ICCON Consulting experts have extensive experiences on how to validate the computer systems in the Pharmaceutical Industry. If you have short time to prepare any Inspection or Audit, please do not hesitate to contact with us.
Our experts are available to focus on your projects to get the validation done quickly. We use a risk-based validation approach to validate only what needs to be validated to ensure product quality and data integrity. If you have an existing systems that need retrospective validation, we can promptly remediate the situation, so you don’t get caught in a state of non-compliance. Our experts;
- Qualify all instrumnets in the laboratory according to the new USP <1058> risk-based instrument qualification requirements.
- Efficiently create validation documentation that is ready for Inspections.
- Develop SOPs that build in infrastructure and ensure compliance: network/data security, backup, archiving, disaster revovery, electronic records and signatures, record retention with validation team.
- Develop contracts for purchasing, installation, maintenance, and professional services.
- Coordinate and perform hardware and software installation
- Actively participate in the hands-on validation activities
- Perform periodic review to keep the systems in a validated state