Data Integrity On-site training

Our staff is prepared to help you manage your GxP relevant data.

Five Validation offers on-site training in Data Integrity, enabling employees to handle GxP relevant data the proper way.

All critical data generated in the production process can contain important information related to product quality, and it is important to assure that the integrity of this data remains safe, or, according to the FDA “ALCOA" concept: Attributable, Legible Contemporaneous, Original and Accurate.

More recently, this concept was expanded (“ALCOA+”) to cover also: Complete, Consistent, Enduring and Available.

Data Integrity Assessment

Gap assessment - Survey of adequacy of all systems.

Through the Data Integrity Assessment, the Five Validation team delivers a complete overview of the adequacy needs of all systems following the policies and/or international guidelines, in order to present an adjustment plan to help your company follow Data Integrity guidelines.

Working together with the Quality Assurance team, the GxP data should conform to Data Integrity guidelines in order to streamline cost by eliminating excess data verifications.

Consulting for compliance with Data Integrity guidelines

Adapt the production process to Data Integrity standards.

With answers provided by the Data Integrity Assessment, we can present a plan in order to have production processes and Quality Control in compliance with Data Integrity rules, including ways to assure that critical data protection is included in the SOPs that cover Production and Quality Control.

Implementation of post-Assessment mitigation Action Plan

Actions focused on eliminating risk to Data Integrity.

With Data Integrity Assessment in hand, the team is able to begin the data integrity risk mitigation process for the GxP Data.

In this phase, the actions will be focused on possible adjustments in the current production process, eliminating factors that can be considered risky for Data Integrity implementation.

Implementation of action plans for Data Governance

After ensuring Data Integrity, it is time to improve Data Governance.

Five can support the company to implement actions to ensure that the critical data records are accurate, complete, and consistent. Moreover, we offer support managing policies of Data Governance in order to maintain Good Practices as achieved by the team.

Actions and education to maintain Data Governance practices, such as:

  • Ensure control access and authorized individuals
  • Clearly define access profiles
  • Clearly define all metadata of complete records
  • Assess and record the evaluation of all relevant GxP Data
  • Implement, monitor and review Audit Trail before the release of the product
  • Perform backups regularly
  • Include Information Security and Data Integrity risk, requirement and tests within the Computerized System Validation approach