“It is not enough to do your best; you must know what to do, and then do your best”. So said W. Edwards Deming, quality guru and founder of the concept of continuous improvement that transformed Japanese industry after World War II. With this maxim, Deming captured the essence of Quality* management and validation in the medical literature monitoring (MLM) software that is used in pharmacovigilance. Excellence in practice is essential. But to be of value and – most importantly – to comply with regulations, it must also follow rigorous and well-documented steps.

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For MLM software development, this means clear best practice and a firm understanding of what “validation” means. In this context, it not only means that the product is sold to perform a specific function, but also that it is clearly fit for its use to perform a particular regulated task. And to ensure literature monitoring stays in line with best practice, software must be underpinned by an underlying Quality management support structure that is aligned with relevant regulations such as GAMP, CFR and ICH.

Given the scale of “knowing what to do” in Quality management and validation, could non-compliance be less painful? The colossal fines handed out for due diligence failures in the pharmaceutical industry suggest not. Managing Quality management and validation for MLM software in-house demands significant resources. But if regulators don’t find validated products, they are likely to apply even more intense scrutiny.

Fit-for-purpose MLM software needs to have Quality management and validation built in, with controls that provide traceability all through the process. Its defining characteristics should include:

1. Qualification of the software and hardware
2. Training of users and admins
3. Procedures to define roles and responsibilities
4. Inspection of outgoing product, data and software
5. Audit of the entire process to ensure adherence to procedures

In When best is not enough: How to ensure pharmacovigilance solutions meet essential Quality management and validation standards, we look in detail at why these issues matter and what you can do to benchmark your own medical literature monitoring software.

We believe you should ask tough questions of vendors to be comfortable their solutions meet the required standards.

* Quality is capitalised when it refers to the Quality oversight of processes under regulatory authority.