Data Integrity

The development and stewardship of a medicinal product or device is all about generating data – in fact the only product during the development phase is data. So why and why now is there increasing guidance and expectations for data integrity?

We have deep understanding of the data life-cycle and the challenges to and perceptions of data integrity, coming from a combined 70 years experience of data engineering, GxP QA and quality systems and analytical skills.

Our consultancy services include:

• Data Integrity awareness training

• Data Integrity gap analysis – appraisal of data governance and it's role within your quality system, for example:

◦ A level of Data Governance appropriate for Sponsor organisations

◦ Review of effectiveness of data Quality Control processes

◦ Assessment of QC laboratory system vs MHRA GMP Data Integrity Definitions and Guidance for Industry

• Data life-cycle mapping

• Routine and non-routine IT and computer systems validation assessments