Decoding the FDA, WHO and UK MHRA Data Integrity Guidelines & How ComplianceQuest EQMS Helps
Blog | April 26th, 2021

Decoding the FDA, WHO and UK MHRA Data Integrity Guidelines & How ComplianceQuest EQMS Helps

Data integrity is an essential requirement for current good manufacturing practice (cGMP) as it plays a vital role in meeting quality standards. It refers to complete, consistent, and accurate documentation of data and is an essential requirement in this age of digital transformation with highly sophisticated data systems and data storage in the cloud. The need to implement good data practices and necessary controls has increased now due to access to all kinds of data. Companies that are not prepared could find themselves facing regulatory action.

In 2017, it was estimated (by Deloitte) that over 40% of warning letters issued globally were data integrity (DI) violations.

Unacceptable documentation and record management practices were highlighted as key reasons for the failure of data integrity.

In this scenario, regulatory bodies like the FDA have raised their expectations for quality, compliance, and integrity of data (including metadata), providing detailed instructions to the industry in their Final Guidance on Data Integrity and Compliance in December 2018. To combat failings in data integrity, WHO, MHRA and FDA issued draft guidance and DI practices in late 2018 and early 2019.

At ComplianceQuest, we invited Dwayne Calek, a leading medical device, and pharmaceutical manufacturing professional with over 45 years of experience, for a webinar to help us decode the various FDA, WHO, and the UK MHRA data integrity guidelines that were recently updated.

In this blog, we share a few key takeaways from the talk.

FDA, WHO, PIC/S, and GAMP use ALCOA for data integrity, representing the following five principles.

  • Attributable – each data entry must record by who, when, and why it was created
  • Legible – records must be available to read and accessible throughout the data lifecycle
  • Contemporaneous – data must be recorded at the time the work is performed by adding a time zone or using the server time from the organization’s system
  • Original – original data or primary data must be recorded
  • Accurate – the data should be complete, without error, truthful, and reflective of the observation

However, ALCOA further expanded to become ALCOA+ as there was an increase in the number of warning letters. ALCOA+ now includes the following additional principles:

  • Available – the right people can access the data
  • Complete – the data covers all aspects of manufacturing
  • Enduring – the data is stored securely and cannot be deleted
  • Consistent – all data is managed in the same way

The different guidelines created by the various regulators are substantially harmonized with each other. Therefore, changes to data lifecycle management performed to comply with one of the guidelines automatically facilitate compliance with the other guidelines. Many components contribute to compliance with regulations and international standards, from the generation and processing of data to its storage and destruction.

Maintaining data integrity is multifaceted and requires strong policies and controls, staff training, a culture of compliance, and clear segregation of duties.

Watch the detailed webinar recording here,

Watch Webinar

CQ’s EQMS supports data integrity

In 2018, the FDA recommended training that helps employees identify and prevent data integrity issues as part of cGMP training. To create such a work environment, an automated and robust quality management system (QMS) with built-in features is necessary to improve the quality and process of data collection, protection, and preservation. An effective QMS such as ComplianceQuest’s EQMS helps workflow-driven systems collect and record quality data while supporting integration with disparate data sources in a company’s IT ecosystem. Implementing an automated QMS also helps organizations follow the principles of ALCOA+ while minimizing risks associated with data accuracy.

  • Quality risk management and data integrity risk assessment
    Drive strategic decisions on potential threats with the solution to help accelerate assessments, identify and analyze risk trends, and drive risk mitigation activities. Identify the suitable approaches that contribute to process efficiency, improved risk management, and internal controls with our risk framework. The CQ Risk Management Software offers unique AI and analytics capabilities to spot potential risks based on history and trending data along with key metrics. With embedded intelligence, quality and risk management leaders can proactively start their risk mitigation efforts before it becomes a significant challenge.
  • Good documentation practices in data integrity
    Regulatory compliance is stringent. With an electronic approach to document management across the enterprise, you’ll have a central repository to create, modify, review, approve, store, organize, access, and share documents globally in a controlled manner. Track each document from origin to obsolescence with analytics, graphical dashboards, integrated collaboration, and workflow tools. With CQ Document Management, you can manage the entire document lifecycle, gain complete visibility and rely on a single source of truth across all locations for more effective decision making.

Data has become crucial for businesses and its integrity is essential not only for regulatory purposes but also to improve the value businesses can draw from it. A solution such as ComplianceQuest’s EQMS provides an enterprise-wide view of data as a single source of truth and ensures integrity while allowing each function to leverage the data to suit their purposes.

To know more about ComplianceQuest’s data integrity capabilities, request a demo here:

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