Assessment
Need to implement or
align your data integrity practices
- Monitoring, database tools and sorting of problems
- Assessment of data integrity issues
- Risk analysis on GMP impact: safety, efficiency, product quality
Solutions:
- Data governance (organizational, technical, revision)
- Education and communication tools
- Specific considerations for computerized systems
Greater awareness and understanding of data integrity will help you:
- Know the GMP requirements for data integrity
- Improve your quality management system by including data integrity
- Assess the integrity of the data in its current state and create a remediation and improvement plan
- Identify conditions that could lead to a higher risk of data integrity violation
- Improving your training programs
- Reduce gaps related to data integrity by better identification of root causes
Remediation
Need to implement or align your data integrity practices at the Shopfloor level
- SOP's writing and operational documentation
- Design documentation to allow team training
- Supervision of installation on site
- Evaluation of new practices and improvement
Solutions:
- General SOP for data governance (organizational, technical, revision)
- Operational instructions and protocols
- Specific axes for each article according to the evaluation outputs
- Qualification and validation- System security- Audit trails- Data capture / entry- Data review- Storage, archiving and disposal- People training
Your Risk
- International regulation has focused in recent years on data integrity issues
- EMA recommends suspending medication due to data integrity concerns (> 700 products recommended for suspension)
- Data integrity applies to all elements of the quality management system, also for paper and electronic systems.
- Regulatory authorities take a closer look at signs of changed and corrected records
In-Situ Training
- Evaluate incidents involving data integrity and identify potential causes
- Recognize sources of error
- Propose solutions to reduce these risks and prevent errors
Autres services
Profitez d'experts expérimentés et bénéficiez de leur expérience
