Equal principles apply for GxP organisations as the MHRA formally introduces Data Integrity guidelines

15 March, 2018

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.

Even more so, since March 2018 when the MHRA published its GxP Data Integrity guidelines, formally including Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Pharmacovigilance Practice (GVP).

This is highly relevant to the introduction and implementation of new systems, migrating systems or retiring systems, maintaining the Data Integrity throughout the life cycle is a major challenge for whole industry.

As a manufacturer, contract lab, CMO, CRO or system supplier do you have concerns regarding Data Integrity or Computer Systems Validation?  As a system supplier or contract organisation you will be challenged on these and a bad inspection may result in lost orders and customers.  If so we can help you.

Data Integrity Auditing - benchmark your compliance, understand your weaknesses and plan for remediation.  Take advantage of new techniques and industry expectations to reduce cost and increase compliance.  Demonstrating you are in control will enhance your business.

• DI Site Audit (benchmarking and assessment)
• DI Program Audit (auditing of an ongoing DI program vs best practice)

Data Integrity Training – ensuring competency of your team.
• DI for Management (½ day) 
• DI for Operational Staff (full day)
• DI for Practitioners (full or ½ day)
• DI for Staff (also Online DI Course – 20 minutes duration, ideal for training the masses)

Data Integrity Toolkit - leverage and tailor our tools.

Data Integrity Program Support - we have a team of highly experienced professionals to support you.

By simply engaging us you will have improved your defendable position to regulatory and customer inspections – “We have recognised the gap and have engaged Clarity Compliance Solutions to ….”.

Take a look at the MHRA Data Integrity Guidelines - March 2018

Online Data Integrity Training

Aimed at organisations, new starters and existing staff, as part of the ongoing DI training. The course provides an overview of DI threats and issues posed within paper/electronic systems an

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Data Integrity

Do you have concerns regarding Data Integrity? We would be delighted to have a chat with you and help you leverage our expertise, knowledge and skills.

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