Data Integrity Guidelines - do you need 'Clarity'?

15 April, 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).

Leverage our expertise

We have been helping clients comply with Data Integrity for a number of years.  Building up a wealth of client inspection experiences and domain knowledge we enable our clients to leverage our expertise - reducing risk and costs, and improving compliance and efficiency. 

Our team of consultants, specialist personnel and project delivery teams
, have worked across many countries.  We will support you and your business, so you no longer have to struggle to find the skills, resources and knowledge.  Working with 'Clarity' is like adding us to your team, freeing you up to focus your energy on the business you know.

We have developed our own approach to implementing Data Integrity, to include a Data Integrity Toolkit and developing a Data Governance Framework.  To include the delivery of open forum, in-house and online training and carrying out many Data Integrity audits and program support.

Our approach

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

Our Training 

Data Integrity training is a critical element in the development, implementation and operational delivery of a data integrity program.

Ensuring compliance with the evolving Data Integrity guidelines from the MHRA, FDA and other regulatory bodies is a major challenge for pharmaceutical manufacturers, contract organisations (manufacturers, research and laboratories) and system suppliers.

During regulatory or client/customer inspection, your organisation will need to demonstrate that your staff have a suitable level of Data Integrity knowledge and are competent to develop key components, delivering the key activities.  Training records and competency are easily inspected during regulatory inspections and very often a source of inspection findings.

Our training courses update you of current regulations, guidance and regulatory expectations.  They aim to improve your internal procedures and furthermore encourage and drive a positive quality culture to leverage change, delivering more compliant operations. 

Speak with one of our experts

If you have questions and concerns regarding Data Integrity, please feel free to get in touch, we would be delighted to have a chat with you.

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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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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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Specialist Personnel and Project Delivery Teams

We can provide you with the market leading knowledge and skills your business needs to help you manage your compliance issues efficiently and cost-effectively without fuss and provide you with confidence for regulatory inspection.

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We at Clarity Compliance Solutions have vast experience in conducting audits for our clients. Following our Review – Advise – Deliver, we help our clients identify the issues, plan the remediation and provide skilled resources to provide the remediation.

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