Data Integrity in the Context of ERP Selection for Life Science Companies

Firstly, it’s worth noting that this blog is niche! It is specifically written for those of you in the Life Sciences sector who are selecting an ERP system that you plan to validate for use in a GxP environment. If you’ve discovered this blog because you’re contemplating an ERP project but you’re in another sector then you will find a wealth of blog posts on ERP Selection here.

GAMP 5 Guidelines and Data Integrity Principles

We typically see clients lean on industry guidelines such as the GAMP5 guide when selecting, implementing, testing and validating an Enterprise Resource Planning (ERP) system in a regulated environment. 

In the latest major update to the GAMP 5 Guide (2022) it continues to prioritise the three core pillars – patient safety, product quality and data integrity. Whilst the new update leaves the door open for retrospective validation, it is strongly suggested that a User Requirement Specification (URS) is used during the supplier assessment phase of a project. As such it is vital that we capture and document requirements related to data integrity. Additionally, it is suggest that a framework for data integrity be used to support this. We often see the ALCOA+ principles used here. 

The ALCOA+ principles for Data Integrity are a set of guidelines used primarily in regulated industries such as life sciences, healthcare and scientific research to ensure data quality and reliability. The principles define that data should be Attributable; Legible; Contemporaneous; Original; and Accurate. In addition, the ‘+’ extension recommends that all data is Complete; Consistent; Enduring and Available. 

Detailed ALCOA+ Principles Breakdown in the Context of ERP Selection

When we select an ERP system that we intend to validate for use in a GxP environment, we must consider both the ALCOA+ guidelines and the underlying functionality when we write the User Requirement Specifications (URS). In order to write requirements we must first understand how we should think about these guidelines in the context of modern ERP systems:

Attributable:

In an ERP context, this means that all data entries and changes should be traceable to a specific user. The system should have robust user authentication and audit trail features to record who entered or modified data, when, and why.

Legible:

Data in the system should be easily readable and understandable. This applies to both the user interface and any reports or exports generated from the system. Clear labelling, proper formatting and appropriate use of data types are crucial.

Contemporaneous:

Data should be recorded at the time of the activity or observation. In this context this means real-time data entry for transactions, inventory movements and production activities. The system should accurately timestamp all entries.

Original:

The system should maintain the original data entries, even when corrections are made. Instead of overwriting data, the system should use versioning or change logs to preserve the original information while allowing for updates.

Accurate:

Data entered into the system should reflect the true state of business operations. This requires input validation, data consistency checks and in some cases integration with other systems to ensure accuracy across the organisation.

Complete:

All relevant data should be captured in the system. This includes the ability to mandate required fields and that the system can accommodate all necessary information.

Consistent:

Data should be recorded and maintained consistently across different modules and over time. The system should enforce standardised data formats and business rules to maintain consistency.

Enduring:

ERP data should be securely stored and accessible for the required retention period. This involves proper backup procedures, data archiving and the ability to retrieve historical data when needed.

Available:

ERP data should be available to authorised users when needed. This involves reliable system uptime, quick data retrieval and performance optimisation for data queries. 

Crafting Effective Requirements: Beyond Generic Statements

Whilst it may seem that this will make documenting requirements quite simple, presenting potential ERP vendors with the ALCOA+ principles as system requirements is not sufficient. Consider the following example of a poorly written requirement:

“Data must be traceable to the individual who generated or changed it”  
In response to this requirement vendors may provide generic templated responses making it difficult to assess vendors claims. They may take a narrow technical interpretation of the principles, overlooking their holistic nature.

As you document your functional requirements you should carefully consider if you have captured each requirement in sufficient detail such that a response will allow you to assess that the solution will be compliant with any applicable underpinning ALCOA+ principles. When we apply this context the requirement above, we might write it like this:

“It must be possible to mandate a 21CFR Part 11 compliant electronic signature for the following types of activity and transactions: …… Describe how this will be executed” 

You will also need to document requirements describing what you consider to be a 21 CFR Part 11 compliant signature. Gathering functional requirements for an ERP system in a GxP environment is not an easy task and something we will discuss in a later blog post.

In addition you will need to document technical requirements around things like backup procedures, data archiving and data storage locations. This is not a straightforward task either and we would suggest using the services of a specialist company like Lumenia Consulting or similar to help with this. 

This will allow you to fully assess if the system will allow you operate your business using a combination of systems and processes in a way that will allow you to maintain data integrity in the most efficient manner. 

Find out more:

Check out our ERP Selection services for information on how we can help with documenting requirements or any other element of your ERP selection, or reach out to Mark McKeigue.