Data Integrity 
Assessment & Implementation


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


  • 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


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


  • 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

Read more

Autres services 

Profitez d'experts expérimentés et bénéficiez de leur expérience

Inspection ANSM
Non Compliance