We ensure the life cycle of the data in all stages of the processes.
Ensure data integrity compliance.
According to Annex 11 of the Good Manufacturing Practices (GMP), the computerization of processes cannot be detrimental to product quality and process control. Risk management should be applied throughout the life cycle of the computerized system taking into account patient safety, data integrity, and product quality.
Therefore, data and information management should be considered as a process in itself and not as something subsidiary to each operational process.
At Oqotech, we help our clients design and implement their Data Integrity team qualification strategy, enabling them to ensure the data life cycle in all stages: generation, use, distribution, storage, retrieval; for any format or media used to record, process, archive or retrieve it.
- Definition of the global data integrity qualification strategy applied to all process equipment.
- Execution of the qualification.
- Results review and critical deviation resolution plan.
- Maintenance of the control status.
- We design and implement your team qualification strategy in Data Integrity.
- Establish the multidisciplinary project team, team criticality based on risk analysis, acceptance criteria, and methodology to follow.
- Verify each process team based on compliance with the ALCOA+ rule.
- Generates an action plan to correct critical deviations.
- Establishes procedures to maintain the control status continuously and plan periodic audits (internal and to service providers).
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If you have any questions, please contact us and we will respond as soon as possible.