For Next Generation Life Sciences.


Data Integrity and ALCOA+ as it applies to Software as a Medical Device

A poll during the latest Odyssey VC webinar on Compliant Digital Transformation for Life Sciences showed that many of our peers in the Software Development, Connected Health and / or Software as a Medical Device arenas are not familiar with the requirements for Good Documentation Practice (GDP) within the life science regulations. 

With the advancement of computerised systems within medical devices, and with software now being classified as a medical device in its own right, it is key for these organisations to become familiar with what GDP and ALCOA are and why they are important. GDP and data integrity are a key requirement in ensuring product quality and patient safety, and are essential for regulatory approval to most markets.

GDP is more than just a way of writing. GDP is a way of creating, processing and preserving data to ensure it is accurate and correct for the duration of its lifetime. A simple way to do this is through application of the ALCOA principles.

ALCOA is the term coined using the acronym for the five original principles of data integrity. The acronym was first used during the 1990s by Stan W. Woollen, FDA Office of Enforcement. Through application of the ALCOA principles, regulated organisations can ensure data integrity for their products and their processes.

So what is ALCOA? As mentioned above, ALCOA is an acronym for the principles of data integrity. For data or records to meet GDP requirements, the data must be Attributable (traceable back to the person / system that created (or altered the data), Legible (in readable format for the lifetime of the data / record, the data / record endures (remains legible & available) for the lifetime of the associated product / process), Contemporaneous (recorded in real-time, no back-dating or retrospective recording of data), Original (the true record / the master record), and Accurate (validated, contains true information only, is not misleading, is complete, does not omit key information).  At times, the term ALCOA+ is also used, this captures the above principles of ALCOA with the additional principles of ‘complete, consistent and enduring’ called out separately.

ALCOA and GDP requirements apply to all records / data associated with the life-science product, they apply regardless of whether the data is record in hardcopy or electronically. Refer to Table 1. below for examples of application across both formats. 

ALCOA principles are essential in helping an organisation protect the patient or end user of a medical device. If assessed and considered up front, then data integrity can be built in during the design and development of software. Consideration of these principles  throughout the software development lifecycle and validation can not only improve the quality of delivery of a product but can also improve the efficiency with which an organisation can bring their product to market.

This article is taken from the Reg Updates section of our Compliant Cloud quarterly newsletter. Click here to subscribe.

Part 2 of Odyssey VC’s ongoing webinar series concerned the application of ALCOA+ principles to your compliant digital transformation and took place on the 28th of September. Part 3, “Why adopt cloud technology for your GxP applications?”, will take place on the 2nd of November.