Computerised systems validation is essential for medical device and pharmaceutical manufacturers. This article pinpoints the three areas that businesses need to get right to ensure that the computerised systems they use for labelling meet all the GxP requirements set out by industry regulators.
Validation of computerised systems is a non-negotiable requirement enforced by regulators such as the FDA in the US, the EMA in Europe, TGA in Australia and HS-SC in Canada.
The ability to demonstrate adherence to appropriate practices and processes that underpin a quality driven, risk-based approach to computerised systems validation is a prerequisite to being able to operate in any highly regulated market, including medical device and pharmaceutical manufacturing.
As part of GxP regulations, manufacturers involved in these industries must adhere to good manufacturing practices (GMPs), which are defined as “a system of processes, procedures and documentation that helps to ensure that products are consistently produced and controlled according to quality standards.”1
It’s necessary to zero in on GAMP 5 guidance for GxP computerised system compliance and validation as this is the standard that regulators work to.
Outdated labelling systems in need of an overhaul
Enterprise labelling is a classic area in which computerised systems play a vital role by providing the highest quality and most accurate description and branding of products such as medical devices and pharmaceuticals. Meeting these regulations requires applying the best quality management systems and standard operating procedures (SOPs) to the design, development and delivery of labelling software.
Medical device and pharmaceutical labelling is ripe for modernisation, but many manufacturers are still using outdated systems for product labelling because they are not willing to bear the validation burden of implementing a new one.
Beth Peckover
The validation of newly built computerised systems is an involved task and can take several months to complete. Usually, it entails the performance, operational and infrastructure qualification of regulated systems used to manufacture medical devices and pharmaceuticals.
Product recalls carry a heavy cost
Correct labelling is a key requirement for manufacturers of medical devices and pharmaceuticals. Analysis of FDA drug recalls shows that, between 2017 and 2019, 14.9% of recalls occurred owing to labelling issues.2 Recent statistics also highlight that 9% of global medical device recalls were because of label errors, equating to more than one million items.3
The FDA explains that medical device manufacturers must incorporate several elements into their quality assurance (QA) programme that relate to labelling to meet the GMP requirements of Quality System regulation. The potential damage to consumers and company reputation owing to a recall from not meeting these standards is extreme; patient safety can be put at risk and businesses shut down because of incorrect labelling.
But validating a new computerised system is an involved task. Many medical device or pharmaceutical manufacturers find themselves in a catch-22 situation when assessing their labelling system options. On the one hand, they may have a legacy labelling system that needs updating but is validated; on the other, developing a new system requires full validation from scratch.
Developing a system in-house puts the entire validation burden on the medical device or pharmaceutical manufacturer themselves. If a manufacturer cannot trace the driving factors behind why a computerised system was built or selected, or how to satisfy and test them, then it becomes challenging to establish whether the system is fit for purpose.
The lack of a proper definition of why a particular system is in place can lead to inconsistent and incomplete computerised systems, as well as feature creep gaps when deploying the system. If a manufacturer does not document their requirements and testing process clearly, it becomes impossible to claim to have a compliant system in place.
Ongoing compliance adds further cost and process headaches
Manufacturers are likely to incur high costs and spend more effort in the validation of their own bespoke on-premise applications when labelling processes update or change because the responsibility of performing the qualifications after each release remains in-house.
And constant rule assessment doesn’t stop there. Requirements must be kept up to date throughout a software system's lifecycle.
To ensure that all regulations are followed through on a regular basis, manufacturers are required to establish standard operating procedures and a lean governance structure to interpret all regulations and requirements on the organisational level … and ensure action is taken when appropriate.
Validation-ready alternatives
Thankfully, there are prevalidated third-party solutions that can ease the compliance pressure of having a modernised, best practice labelling system. Such a solution should build and demonstrate GxP-compliant processes across the creation, review, print and publication of all product and package labelling, especially software and processes that align with GAMP 5 quality guidelines and 21 CFR Part 11 regulations.
With this in mind, there are three critical areas to consider when setting criteria for a validated enterprise labelling system.
Validation straight out of the box: An alternative option to developing a bespoke solution in-house is to leverage existing software on the market. This can be locally installed “on premise,” but having the software delivered as a software as a service (SaaS) model can offer significant benefits when it comes to efficient validation, both during the initial implementation and as part of the ongoing maintenance of the system.
By using software that’s hosted in the cloud, the solution provider takes responsibility for the IQ/OQ validation activities with each software release, meaning the manufacturer minimises their own validation efforts and cost with a “validation-ready” software system.
Transfer the validation burden to your supplier: Beyond delivering a validation-ready system, a software supplier who is experienced in delivering validated software to regulated customers will be able to further relieve the burden by taking responsibility for other aspects of the validation if requested, such as creating a traceability matrix or writing the test scripts to be used during user acceptance testing (UAT).
It’s possible to “outsource” the majority of these activities to the supplier, leaving only the execution of the UAT to the manufacturer.
Regulated industry alignment brings compliance expertise and collaboration: Working with a trusted software partner brings industry wide compliance expertise and knowledge.
Although every medical device or pharmaceutical manufacturer will have their own unique processes and business requirements, there are common industry challenges and scenarios that medical device and pharmaceutical labelling software providers will have encountered before.
An industry specific partner should speak the language of GxP and GAMP 5, with in-house experts dedicated to continuous education and training to stay up to date with the latest guidelines and best practices.
This enables that partner to collaborate directly with a manufacturer, consulting with them on how changes to labelling may impact compliance going forward and discussing steps required to make sure new processes adhere to current best practices.
Guarantee a validated platform
The speed of change in information technology, combined with constantly evolving manufacturing processes, makes adhering to GxP and GAMP 5 regulations in highly regulated industries a continuous task. This quickly becomes unsustainable when a manufacturer weighs up the compliance pros and cons of deploying a bespoke on-premise system for enterprise labelling.
Partnering with a reliable software provider becomes a critical factor in terms of guaranteeing computerised systems validation, creating a platform for compliance with industry mandates for now and the future. The result is a collaborative and efficient process that ensures compliance, eliminates risks and delivers huge value to your manufacturing processes.
References
- https://isoupdate.com/standards/gmp.
- www.ncbi.nlm.nih.gov/pmc/articles/PMC7395820.
- www.stericycleexpertsolutions.co.uk/recall-hub/blog/medical-device-recalls-and-labelling---sticky-issue.
