validation

The silver lining in a labeling system validation effort: four tangible business benefits

Susan Gosnell Life sciences

There’s no way around it. Regulators require that life sciences companies validate their solutions. At the same time, manufacturers are under pressure to streamline operations, reduce costs and increase efficiency to compete in a challenging market environment.

In many ways, it might seem like a near-impossible task: spending the time and resources necessary to achieve and maintain compliance, while at the same time finding ways to simplify and improve the manufacturing process. The good news is that it can be done. Many life sciences companies have successfully validated their Enterprise Labeling Solutions and used the validation process as an opportunity to increase operational efficiency.

Let’s take a closer look at the silver lining in a validation effort – the operational, commercial and business benefits that can help your business grow while “checking the box” on compliance.

  • Avoiding recalls – By validating software at the time of installation, and whenever major updates are introduced to the system, life sciences companies can detect software anomalies before they impact their manufacturing operations. Additionally, the extensive testing that companies perform in a non-production environment can greatly reduce the possibility of system failure.
  • Improved use of technology – Successfully validating a software system requires comprehensive software testing, inspections, analyses and other verification tasks at each stage of the software development cycle. While this takes time and resources, the result is a more thorough understanding of the software and its capabilities than a company might have had without the validation process. When working with an Enterprise Labeling Solution, this deeper insight can help companies take full advantage of automation and integration capabilities that can greatly simplify and optimize their labeling processes.
  • Improved operational efficiency – The validation process gives employees the opportunity to familiarize themselves with the labeling solution before it goes live. This means they will be knowledgeable in using the system once it’s migrated into production.
  • Full traceability and increased customer and supplier confidence – When done right, validation processes ensure that the labeling system works as intended. With that confidence, companies can be sure the software will provide detailed, searchable records making it easier to comply with future audits and regulations. A successful validation process can also give a company’s customers and suppliers confidence in its ability to meet regulatory compliance, in turn supporting patient safety.

Realizing these benefits requires life sciences companies to take a best-practice approach to their validation projects. We are hosting an upcoming webinar with MedTech Intelligence where we will discuss how companies can reduce the burden of validating their Enterprise Labeling solution and share use cases from several Loftware customers that leverage these best practices to reap the benefits of increased operational efficiency. You can register for the webinar here.

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