Arena Blog

How Successful Medical Device Companies Validate Their Software

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teddy-bearIncreasing regulatory requirements are making it more challenging for medical device companies to respond to opportunities rapidly and get products to market quickly.

The complexity of validating updates to software has forced many cutting-edge medical device companies to forgo updates, upgrades, and bug fixes or—at a minimum—put them off. Unfortunately, outdated software can negatively impact a medical device company.

How often have you heard this painful story: a company purchases and configures the software according to its existing business needs and regulatory requirements. The software is painstakingly validated and locked down for an eternity; yet, during the next 10 to 15 years, the software vendor releases significant and important software updates—but each one requires a complete re-validation of the software, which the company feels it just cannot afford and consequently ignores.

The company is left relying on the original, now-outdated, version of the software that no longer meets the company’s changed requirements. So while it may in fact be ‘working’ — it is also potentially ‘harming’.

The good news is that medical device companies can have the latest, most up-to-date versions of their enterprise software with minimal validation effort and cost. Arena’s whitepaper, “How Med Device OEMs Simplify Validation & Streamline Compliance” covers the benefits of using cloud-based software and validation maintenance within a multi-tenant framework. With validation maintenance in a multi-tenant solution, each update is validated by the software vendor against a set of predefined common requirements shared by all medical device customers.

Medical device companies that have used the Arena Validation Maintenance Service (VMS) with Arena PLM report significant cost and time savings associated with ongoing software validation, allowing them a renewed focus on core competencies where the real margins reside. Additionally, these companies have found that the VMS component further accelerates the initial product lifecycle management (PLM) enterprise software implementation and streamlines compliance.

“Medical device companies must adhere to very complex and heavily regulated design and development processes and maintain regulatory compliance throughout the entire product lifecycle,” said Yelena Bolton, senior program manager, life sciences at Arena Solutions. “Our cloud-based PLM validated solution enables compliance and integrates product records (DMRs/BOMs), quality records and documents (DHFs), quality processes (CAPAs, CARs, NCMRs, etc.), and changes into one centralized system of electronic records, easily accessible by all cross-functional teams including suppliers. Customers spend significantly less time and money on ongoing PLM system validation and documentation, and more time developing better products that save lives and generate revenue.”

Arena’s VMS offers ongoing Arena PLM release validation against predefined intended uses, as well as the complete documentation of validation activities and results for each Arena PLM release. Arena VMS removes the headache of PLM product validation so that Arena customers can always enjoy the latest updates without regulation concerns.

With this validated solution, Arena has consolidated all product records and quality documents into one centralized system, offering visibility, cross-functional collaboration, and long-term tracking of quality resolutions. This is critical for medical device manufacturers since they are required to maintain and demonstrate FDA 21 CFR Part 820 Quality System Regulation compliance on a consistent basis.

Innovative manufacturers that run outdated software to manage new product introductions projects are potentially undermining their own success and growth. A proven solution exists in the form of subscription-based multi-tenant single-instance software architecture and a corresponding validation maintenance solution.

Click here to download the whitepaper, “How Med Device OEMs Simplify Validation & Streamline Compliance.” And click here to learn more about Arena’s VMS solution.