Compliance is a necessity that can achieve the greater good in your GxP data - Arkivum

Best practice approaches / 19 Aug, 2019

Compliance is a necessity that can achieve the greater good in your GxP data

Working in such a highly competitive market, it is becoming increasingly difficult to stand out from the competition. Complex data requirements make it difficult to provide competitive prices and how do you make sure you’re providing your clients with enough data (and diverse data at that) to make your research valuable and insightful?


The industry has been going through a period of digital transformation. Though often that is right at the start, looking at moving away from manual and paper-based processes, where possible. Industry disruptors are already focused on “what’s next” and looking at ways to provide more diverse data and richer data sets for their customers. One interesting emerging use case is the use of Internet of Things (IoT) devices to broaden the reach of participants for clinical trials and virtualising the process as much as possible. The idea is that by virtualising clinical trials it will make them more scalable and increase the diversity of the participants to provide a richer data set.


Good data management


GxP is synonymous with practicing good data management for regulated applications.  When systems (and everyone is using at least one) are utilised in a regulated area, the data must fall under GxP principles and governance. This would be the application of ALCOA+ principles and meeting 21 CFR Part 11 compliance. The challenge is to create a single source of your data to access and re-use the data, all whilst keeping the data complete, consistent, accurate and in its original form. 21 CFR Part defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.


These standards give both sponsor and regulatory bodies assurance that data collected is accurate and intact.


Data diversity and exponential growth


Applying GxP processes enable companies to leverage existing and emerging technologies. Not only do they expedite and extend the collection of data, when correctly implemented they can streamline the process to deploy technology in a compliant manner and expedite getting new products to market.  While there is certainly regulatory burden in deploying solutions, adopting standard GxP processes can reduce this effort significantly. As technologies advance in the areas of machine learning, AI and the internet of things, further efficiencies can be applied in the form of self-auditing and validation of systems.


Challenges will continue to increase as more connected devices, wearables, and virtual trials will shift the amount and sources of data collected. Data continues to exponentially increase. It’s important in a world hurtling toward cloud and personalised devices that the effort and methods of data compliance and rapidly changing devices and software move toward intersection rather than drift further apart. For now, centralising and consolidation of data is a must-do activity as these technologies continue to evolve at pace.


What do you need to be doing now? The cost of doing nothing


Organisations can easily fall into the trap of doing nothing, which is a decision in itself, and surprisingly, often a costly one. Getting your data and processes under control now will not only deliver cost efficiencies and reduce the risk of fines or security breaches etc, it will put your organisation in the best position possible to innovate and keep ahead of this evolving industry.


Bring your data together, where possible, to create a single source and apply GxP principles and appropriate data standards. By defining a central data strategy across your metadata standards, retention policies and ingest standards you will be able to easily add automation to these processes and even include legacy, acquired and proprietary data. By adhering to industry standards to deliver GxP compliant data, it will aid easier data migration between organisations for collaboration or data acquisition opportunities. Comprehensive audit trail reports, demonstrable chain of custody and an ability to securely export data will only enhance this further and help you demonstrate trustworthiness of your data. As will the ability to demonstrate 100% data integrity.


Further efficiencies can be gained from automating your compliance management, for example, by automating your ALCOA+ processes you can ensure compliance in an affordable way. Automation can also be extended to your data retention schedules and mechanisms for secure removal of data gaining from a reduced time to manage and decrease in human-based errors.


Once you have your data under control, you’ll be able to extend this value to your customers through better prices, neatly packaged data that meets data standards and compliance mandates, and through ongoing management of their data accompanied with an ability to minimise their data exposure by purging data beyond retention periods.


What’s in the future that I should start thinking about now?


  • Automation: We are just at the very start of adopting automation in our business and data management processes. This will grow significantly as people become more comfortable with (and trusting of) automation and machine-learning and artificial intelligence-based technologies become increasingly sophisticated in what they can achieve. It’s completely conceivable to see a future with a heavy reliance on smart tools and the IoT across the life sciences industry, both of which will need good data strategies in place in order to be reliable and successful in their tasks.


  • Digital preservation, long-term access and usability of data: Digital preservation has been around for a while now in other industries (think museums and libraries etc) though it is a relatively new field still in the life sciences industry. This is about ensuring you can access and use your data in the long-term, whether it’s 5 years or 50 years from now. Read this blog for more information on digital preservation.


    • Collaboration and beyond: The increasing costs of operating a business in the life sciences industry, accompanied with the increasing competition and number of disruptive start-ups entering the market is making the ability to collaborate with others a necessary requirement. An essential part of this is having your data in good shape to make it even more appealing for potential partners to want to work with you and providing you with a competitive edge over others.



Compliance is a necessity that can deliver a greater good when it comes to your GxP data


Compliance is an essential part of running a business in the life sciences industry, and rightly so. Done well, it can be used to increase your organisation’s competitive edge by supporting reliability and repeatability of your data, attracting more collaboration opportunities and supporting the ability to bring new innovations to market, quickly.


We recently held a webinar with guest speaker, Eldin Rammell, on ‘Regulatory compliance for data archiving – what’s expected’ where we discussed specific solutions and the best way of complying with the many different requirements for managing your GxP data.

We are also holding a webinar on December 11th titled; “Digital Data Preservation: The next big compliance hurdle no one knows is coming”. In this webinar we will provide insights into some of the challenges and solutions to this compliance hurdle:

    • What is digital data preservation and why do I need it?
    • eTMF Archives and the EMA guidance
    • GcP inspections; is your data inspection ready?


Register Now

Sridhar Sarva

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