Data Integrity | Clarity Compliance Solutions

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.

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Clarity's support and drive has taken a huge weight off my shoulders

"I would strongly recommend Clarity Compliance Solutions for all aspects of Data Integrity. Clarity have set up and lead our Data Integrity program, delivering excellent training to our management and program teams and setting up our DI governance systems, project managing and leading our assessments, setting up our risk assessment and remediation processes. I would strongly recommend Clarity for Data Integrity, CSV and Quality Systems compliance".

Quality Director.

Contract Manufacturer
Data Integrity Training

Will be recommending to others, especially IT!

I have come away with a good level of understanding and list of actions required to put a Data Integrity plan in to action and review globally. Very useful course.

Global Quality Compliance Manager.
In-House Data Integrity Training

Bringing 'Clarity' to Data Integrity

“David worked with senior management and key operational staff bringing a focus to the increased requirements with regard to data integrity. He presented a series of interactive training modules which were very well received and enabled staff to fully understand how we as a business need to further develop our systems. All feedback from the training was very positive. Ultimately our processes and procedures satisfactorily met the MHRA expectations during our recent audit. Personally I found David easy to work with and I would highly recommend him as somebody who could bring knowledge and clarity to the area of data integrity”.

Ashley Brierley, Quality and Regulatory Director.

Thornton Ross
Online Data Integrity Training

Making training simple

"The online course is ideal for our requirements and vastly simplifies the scheduling and delivery of essential training to all of our team including shift workers - which otherwise is a logistical nightmare".

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