Data Integrity

The MHRA and FDA Data Integrity guidelines have raised many questions for the industry on the whole aspect of Data Integrity and Computer Systems Validation.

We have been helping clients comply with Data Integrity for a number of years, building up a wealth of client's inspection experiences.  We have developed our own approach to implementing Data Integrity, including a Data Integrity Toolkit and our approach to developing a Data Governance Framework.

Our approach would include:

Data Integrity Auditing - understand your DI exposure

  • DI Site Audit (benchmarking and assessment)
  • DI Program Audit (on going DI program vs best practice)

Data Integrity Training - ensuring competency of your team

  • DI for Management  (half day)
  • DI for Practitioners (full or one day)
  • DI for Operational Staff (full day)

DI for Staff - (short online course for training the masses)

Data Integrity Toolkit - leverage and tailor our tools

  • DI Policy, DI Strategic Plan & DI Project Definition
  • DI Assessment Checklist & Procedure
  • DI Implementing Positive Quality Culture
  • DI Standard Operating Procedure (SOP) Review
  • DI Risk Management Tools
  • DI Reporting Tools
  • DI into New Project Development Lifecycle
  • DI Project Handover Criteria

Data Integrity Maturity Assessments

We have developed a unique repertoire of resources to assist in the process of meeting objectives, outcomes and the need for continuous improvement with our Data Integrity Maturity Assessment Toolkit

If you have concerns regarding Data Integrity please get in touch, we would be delighted to have a chat with you and help you leverage our expertise, knowledge and skills.

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+44 (0)1633 400939

+44 (0)7735 204233

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