The GxP Data Integrity guidance from MHRA has now been finalised.
From the MHRA Website:
"The guidance is intended to be a useful resource on the core elements
of a compliant data governance system across all GxP sectors (good
laboratory practice, good clinical practice, good manufacturing
practice, good distribution practice and good pharmacovigilance
It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of which have resulted in regulatory action."
If you need help on evaluating or improving data integrity in your laboratory then MTS can help. We offer auditing services to identify your data integrity issues, consultancy advice on how to assess data integrity risk, perform a gap analysis and implement remediation measures, and customised training courses to inform your staff about data integrity principles and problems so that they are fully engaged with your data governance systems.
Contact us to find out more about how MTS can help you with your data integrity requirements.
Read more about the new guidance on the MHRA website.
Click here for the finalised MHRA guidance.