Proof positive: is your labeling system fully validated?

The introduction of GAMP guidelines in 1994 for medical device manufacturers should have shone a light on the validation processes that underpin companies’ printing systems. The guidelines indicate that quality cannot be tested by batch but must be built into every stage of the manufacturing process.

But despite this – and despite the availability of automated electronic systems that provide end-to-end label lifecycle management, many medical device companies still have some way to go to ensure that their printing system processes are fully validated. In reality, they are inadequate and leave businesses exposed to the risk of failure and the costs of avoidable inefficiency.

So, at a time when companies are seeking to deliver operational efficiencies, are you confident that your printing process is validated? Moreover, can you prove it? Many companies genuinely believe that their systems are adequately validated – but the devil is in the detail. Too often, closer scrutiny will reveal that their beliefs are misplaced.

The GAMP guidelines are emphatic. To ensure printing processes are properly validated, companies are required to produce objective evidence. And that evidence must cover every aspect of the label lifecycle. FDA guidelines make manufacturers accountable for proving that, when designing a label, they’re able to understand the history through version control of the label format and the data that populates it. They also need to demonstrate they have sufficient control of that data to ensure it is not only correct, but that when it’s combined with the format at print stage, the potential for error is mitigated.

The labeling lifecycle is a complex and vulnerable process. With validation critically important, how confident are you that your system is sufficiently robust? How do you integrate your Performance Qualifications (PQs) into your existing system? How do you go through the process without naming conventions on version control and approval processes for formats? How do you generate a single source of truth for your data? How do you audit how your users are interacting with the system? And once you’ve printed your product, how do you know what actually ended up on the label? How do you reconcile that the labels were used or destroyed? And how do you deal with reprints of destroyed labels?
There are many questions, but there’s also a simple answer: If it’s not documented, it’s just a rumor. And if it’s not signed off, it’s merely graffiti. Under strict FDA regulations, if you can’t prove it happened – it didn’t happen. It’s a question of proof – so how do you actually prove it?

To achieve a validated process recognized by the FDA, medical device manufacturers should embrace a fully integrated electronic print system that includes auditable security protocols and lifecycle documentation. By integrating information from multiple source systems into a dedicated solution to ensure ‘one version of the truth’ that is fully documented, a manufacturer removes the element of risk from the process.

The most effective labeling solutions will provide auto-identification and lifecycle traceability to help device manufacturers ensure they are fully compliant with GAMP guidelines.

Are you feeling confident?