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.
Struggling to keep up with training needs?
Training is a critical element in the development, implementation and operational delivery of a Data Integrity Program. Our courses can help you ensure your staff are suitably trained.Our Training Courses
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+44 (0)1633 400939
+44 (0)7735 204233
Computer Systems Validation (CSV)
Validation of Computer Systems is an on going challenge for the regulated industries. Many businesses lack the knowledge, skills and resources to meet the demands that Computer System Validation poses.View service
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