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25th September 2017
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Expert Advice: Clarity Compliance Solutions – Data Integrity

The MHRA Data Integrity programme has raised many questions for the industry on the whole aspect of Data Integrity and Computer Systems Validation.

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.

As a manufacturer, contract lab, contract manufacturer or system supplier, you may have concerns regarding Data Integrity or Computer Systems Validation?  As a system supplier or contract organisation you will be challenged on Data Integrity and a bad inspection may result in lost orders and customers.

Do you have concerns and unanswered questions regarding Data Integrity?  You may very well be asking yourself – “What is all the fuss about?”

Having a clear understanding of the current expectations of EU Inspectors and the FDA, regarding the threats and issues that Data Integrity poses, will demonstrate you are in control and will enhance your business.

By building a robust Data Integrity Programme that is woven in to the fabric of the organisation, with a strong Data Governance Framework, sustainable in its delivery and operation, will enable you to reach your goal in attaining Data Integrity compliance.

Our top tips when considering Data Integrity:

  1. Think big and build Data Integrity into the fabric of an organisation – it’s not about putting sticky plasters on!
  2. Develop a programme approach, for implementation that rolls into the business as usual state, but not forgetting new projects.
  3. Data Integrity is not just about regulatory audits, its client audits too – inward and outward, that may have massive financial impact on your organisation too.
  4. Training is essential, develop a strategy for developing your own experts (or hiring them in) and building an awareness across every member of staff.

Training records and competency are easily inspected and are very often a source of inspection findings.  By simply engaging in training, improves your defendable position to regulatory and customer inspections – “We have recognised the gap and have engaged in Data Integrity training”.

By understanding the threats and issues that Data Integrity poses, offers significant business value, improving internal procedures, leveraging change and delivering more compliant operations.

At Clarity Compliance Solutions, we are Data Integrity experts and have been delivering Data Integrity programme support and training for some time, receiving excellent feedback from clients.

In November 2017, we are delighted to be delivering our first open forum Data Integrity training course, in Cardiff.   The course will cover the background to Data Integrity, why it is important and how its requirements affect both paper-based, computer-based and hybrid systems.

Moreover, the course equips you with the understanding required to enable implementation of Data Integrity governance systems, methodologies and programmes within your organisation.

The Data Integrity Training Course takes place on the 23rd of November and you can read more about it here.

View Clarity Compliance Solutions profile here.