Data integrity is essential for any pharmaceutical company launching a product. Regulations dictate what must be done to assure integrity, but achieving it is often complex. In part two of our series, we look a little closer at some key challenges and how they can be overcome using ALCOA and ALCOA+.
Data integrity – the basics
ALCOA and ALCOA+ are common methods for managing data integrity and good documentation practices for the pharma and medtech industries. ALCOA, a term and framework originally introduced by the FDA in 1990s, as the use of software and data storage systems increased ALCOA+ was developed. It brings additional parameters to data integration in the form of:
- Complete data, including metadata should be a complete representation of the observation made
- Consistent, means processes should be in place ensuring consistency of data throughout the data life cycle
- Enduring, refers to the appropriate maintaining of data to ensure it remains intact and durable throughout the data life cycle.
- Available, is ensuring data is readily available for review when needed.
Typical ALCOA data-integrity challenges
Complete
Incomplete or missing data can take multiple forms, including missing data fields, points, or timelines. This can be due to human error or misunderstanding or your systems and processes may not have been set up with strict data-integrity regulations in mind. To ensure this, it’s important to develop standard operating procedures that secure all identified critical data, for example Electronical Records (ER) as defined in GAMP5, is logged and backed up in its entirety and time-stamped at every step of development. Regular data reviews will also be beneficial.
Consistent
Consistency is paramount in the realm of data integrity. Ensuring that information remains uniform and unvarying throughout its lifecycle is essential for reliable decision-making and regulatory compliance. ALCOA+ addresses this challenge by emphasizing the need for consistent data recording and storage practices. In the pharmaceutical and medtech industries, where precision is non-negotiable, ALCOA+ acts as a guiding principle, fostering a culture of uniformity in data management. By implementing standardized procedures and protocols, companies can navigate the intricate landscape of data integration with a focus on maintaining consistency at every stage of the product development process.
Enduring
Many pharmaceutical companies integrate off-the-shelf, third-party software, into products which can cause unforeseen or unexpected data integrity issues. For instance, many off-the-shelf products only support manual backups locally on a machine. In such instances, you should deploy scripts to automate server backups at least once a day. Relying on users to backup data will backfire at some point; we’re only human, after all.
Available
Availability of relevant data is another critical attribute in the data integrity equation. Pharma companies often grapple with the integration of off-the-shelf, third-party software into their products, introducing the risk of unforeseen data integrity issues. One common challenge is the limitation of some products to support only manual backups locally on a machine. To address this, deploying automated scripts for server backups becomes imperative. Ensuring that data is readily available, even in the face of unexpected issues, is a key tenet of ALCOA+. By embracing automated backup solutions, companies can mitigate risks associated with reliance on manual processes and safeguard the accessibility of vital information crucial for product development and regulatory compliance.
Overcoming the ALCOA and the ALCOA+ challenges
If you feel that the Computerized System Area (from requirements, purchasing, qualification, validation etc.) is something you need to focus on, or just getting started with, we provide specialist support, workshops and gap analyses to help you understand the ALCOA and ALCOA+ process and define a way forward for you to meet compliance. For larger organizations, we can develop tailored solutions to meet the ALCOA+ challenges and ultimately help you get products to market quicker.
Are you interested to learn more about why data integrity is essential for pharmaceutical companies launching a product? Read our first article on the subject ”Meeting data integration challenges in new product development – ALCOA”
