MHRA and FDA Data Integrity guidelines – do I need to pay attention?

The MHRA published its 2018 edition of GCP serious breaches in May which sees Data Integrity featuring heavily in the list of examples of non-compliance.

Data integrity is defined as the maintenance and the assurance of the accuracy and consistency of data over its entire lifecycle.

Data degradation or an inability to prove the integrity of your data can make data unusable and can have serious consequences for your organisation. This could be in the form of large regulatory fines or negative press and company perception, to loss of corporate IP (Intellectual Property) and reduced competitive advantage. A greater impact is it can negatively impact the safety of your end product, which is why this industry is so heavily regulated in the first place.

The Guidance

It has been a little over a year since the MHRA issued its Data Integrity Guidance and 6 months since the FDA released its CFR 211 guidance. What is the guidance about and what should you be doing to make sure you’re aligned with it?

Both sets of guidance agree that Data Integrity is an important aspect of ensuring the safety and quality of your end product as well as allowing repeatability of clinical research and trials.

If you are in a position of a potential data integrity breach; both the FDA and MHRA mandate that you need to be able to demonstrate that you have effectively remediated your problems by investigating scope and root causes, conducting a scientifically sound risk assessment of its potential effects and implementing a management strategy, including a global corrective action plan that addresses the root causes.

The FDA’s list of questions posed in their guidance is a good place to start with understanding the scope of Data Integrity challenges:

• Are controls in place to ensure that data is complete?
• Are activities documented at the time of performance?
• Are activities attributable to a specific individual?
• Can only authorised individuals make changes to records?
• Is there a record of changes to data?
• Are records reviewed for accuracy, completeness, and compliance with established standards?
• Is data maintained securely from data creation through disposition after the record’s retention period?

Source: FDA CFR 211 Guidance

The ALCOA Principle

The ALCOA principle (standing for Attributable, Legible, Contemporaneous, Original and Accurate) is used as the basis for measuring and reporting on Data Integrity compliance.

Although ALCOA has been around for many years, it has now taken a high degree of emphasis. But data integrity is nothing new, so why is the principle getting more emphasis in the life sciences industry now?

There could be a number of answers to such a question, but one is the increasing complexity of the systems with which life sciences organisations are conducting their research and drug development.

Data integrity risks are inherently proportional to the complexities of the processes and technology devices and computerized systems where the data is sourced from. In Research & Development, each step in the data process plays a critical role in the pharmaceutical product lifecycle and the ability to recreate and audit these processes are crucial, thus needing strict policies to ensure this can happen.

What should I do next?

In order to ensure that your data is searchable, reusable and repeatable you need to break down data silos to create a holistic view of your data assets. However, breaking down data silos in a GxP compliant way is not an easy task.

Part of the FDA CFR 211 guidance notes that “[The] FDA expects processes to be designed so that data required to be created and maintained cannot be modified without a record of the modification”

Read our data ALCOA checklist to see how Arkivum can help you to break down data silos whilst continuing to be compliant with GxP principles.