Be Systems and Process Aware: Records, e-Signatures and Validation

Over the past couple of blogs – Be Prepared and Understand the eCTD challenge – I have talked about the challenges pharmaceutical companies with limited marketed product experience face, particularly when seeking to bring products to the larger markets. An important consideration is to understand the expectations and preference of the authorities.

Regulators want to ensure all processes are managed properly. To that end they tend to look at the work in four domains: capacity, instruction, evaluation and mitigation. Can the person or technology involved carry out the task properly? Are the instructions correct? Can the task be reviewed and evaluated so as to detect failure in a timely manner? If they fail, is there something in place to prevent that failure from causing harm?

These questions apply at the frontline production, laboratory systems and distribution stages, but regulators are equally concerned about document management and whether the systems in place to manage the documentation meet regulatory requirements. If drug developers decide to implement computer systems to support any of these areas, they need to be conscious of the specific requirements surrounding e-signatures. These are very specific and it is a fair rule of thumb that if your IT suppliers do not volunteer how they comply, they likely don’t comply.

Whether implementing systems in house or outsourcing to a service provider, manually or as computerised systems, the regulated entity (that is, the company bringing the product to market) has to be happy that they can answer the question “Why did you trust this service provider/computer system to discharge YOUR regulatory responsibility?” This requires that you have documentary evidence showing that the provider/system has been verified as having the capacity to discharge the responsibility, has been clearly instructed to discharge it and that the regulated entity has processes in place to evaluate the performance and mitigate any risks arising from failure. This is the essence of “Validation” regardless of the prefix qualifier that may be applied (for example, computer system validation, process validation and so on).

Bringing a product to market will, of necessity, involve deploying strong document management systems and regulatory submission management systems. It will probably involve these being computerised, either as a dedicated system or using the services of a partner. Whichever way it is addressed, it is vital that the route chosen is robust and demonstrably fit for purpose – in other words, validated. Failure to address these requirements early in the development process, well ahead of the need to deploy, can be the cause of either significant delay or significant additional cost when it comes to submitting a marketing application.

From having a document management backbone, to understanding and preparing for eCTD, to addressing issues around validation, it’s in your interest to ensure your organisation has these matters in hand. If you don’t, do “future you” a favour and start looking now.

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