Automating validation to manage pharma’s complex serialisation systems

In this interview with TraceLink’s Dan Walles, VP Global Solutions following his presentation at FutureLink Munich conference, we discuss automated software validation and how drug companies can benefit from it.

Q. What’s the current state of play in the pharma industry when it comes to serialisation?

A. The gradual introduction of track and trace regulations under the European Union Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) has forced drug firms to adopt systems that allow their products to be followed through the supply chain, from factory to pharmacy.

Validating the software on which these systems run is vital. Traditionally, pharmaceutical firms have manually validated the systems they use as and when required. However, for companies that supply multiple markets or work with several trade partners this approach is highly complex.

Serialisation is a significant challenge for the pharmaceutical industry and the fast and constant evolving regulatory environment. Automating validation through a network-based approach offers pharmaceutical firms a way of reducing their core serialisation challenges.

Q. What are the current approaches to validation and what are the shortcomings?

A. One of the major benefits claimed for single tenant architecture is that software updates can be scheduled, allowing validation resources to be allocated. Provided the software is well understood and stable, this approach can be effective. For example, for processes that need to be updated annually, the ability to schedule and plan well ahead of time is beneficial.

However, for systems covered by a more dynamic set of regulations, such as those used in drug serialisation, this approach is limited. Regulatory requirements change frequently — new rules are added and new standards are adopted — and implementation deadlines vary considerably, which makes forward planning difficult.

Also, because each validation process requires a risk assessment, test scripts and the completion of an installation qualification (IQ) and operational qualification (OQ), this approach can be very resource and time intensive.

In addition, the typical pharmaceutical company has dozens to hundreds of downstream partners, making manual validation an arduous process every time a new trade partner is added, or a trade partner changes their data format preferences, requiring the software system to be re-validated. For example, what happens when a pharmaceutical company using a single tenant solution is integrated with a third-party logistics provider (3PL) that receives serialisation data differently than other 3PLs? The pharmaceutical company would be required to add additional functionalities and re-validate its system every time it integrates with a new trade partner and/or a trade partner changes their preferences on data formats. Clearly a new approach is needed.

Q. Why should companies automate validation?

A. A multi-tenant solution,in which a single instance of a software application serves multiple customers, is an ideal architecture for a serialisation system.

In a multi-tenant environment, all customers share the same software instance. Every customer is running the same version, and each is upgraded at once. This lets the supplier deliver the latest functionality without the risk of interoperability issues or the technical challenges involved in multi-version upgrades and data migrations. Customers also benefit from knowing their systems are compliant.

Network tenancy builds on the multi-tenant approach by allowing users to communicate and set up data exchanges. The approach, which is ideally suited to serialisation systems, ensures data can be shared between organisations. It also makes integrating new partners less complex, ultimately saving all users time and money.

Successfully adopting a network tenancy approach requires a change of mindset. For companies used to controlling the frequency and timing of their routine validation processes this can be a challenge, particularly for resource limited quality and validation teams.Automated testing, a widely accepted approach used for testing and validation, can help to accelerate validation cycles and meet the business demand for new functionality.

Automated validation relies on a framework that records user input and its outcome. The manual process of writing test scripts and capturing user interface screens is eliminated. In addition, automation also allows for the entire system’s source code to be validated rapidly. Usually in manual validation processes only the code for the new functionality is examined with minimal regression testing and no negative testing.

Automated validation enables all functionalities to be tested. The approach also permits full regression analysis and negative testing to be carried out, which positions the customer to better determine if the system meets the business need.

Q. How should it be implemented?

A. Validation is always the responsibility of the user, however creating an automated test suite requires a level of product knowledge that is not typical for an individual company, coupled with the fact that it is costly to both design and maintain for one organisation.

The solution provider also builds validation strategies into the development of new functionalities, which can significantly accelerate the validation process.

In addition, involving the software provider is sensible because they are invested in the success of the process. Software firms want to provide systems that work and learn from any issues that do arise.