FDA Software Validation:

Introduction

Medical device companies must overcome many hurdles to get safe, high-quality products to market. While their primary objective—creating safe, innovative, and valuable health solutions—is challenging enough, medical device companies must also navigate a myriad of regulatory compliance issues before products can be sold to doctors, hospitals, and patients. Accelerating the delivery of new products while ensuring compliance requires comprehensive design controls leveraging the best technologies and automated systems to keep quality and product teams aligned to collaborate quickly and effectively.

To ensure patient safety, the Food and Drug Administration (FDA) and International Organization for Standardization (ISO) stipulate that medical device manufacturers establish and utilize a quality system to ensure products consistently meet regulatory requirements and applicable ISO 9001 and 13485 standards. This type of system, or collection of policies, procedures, and processes, is known as a quality management system (QMS) and helps medical device companies establish and document policies and procedures to demonstrate compliance.

“Implementation was made very easy by Arena giving us complete IQ and OQ documents. The wide range of standard out-of-the-box functionality narrowed the scope of our work even more. This resulted in a very productive and complete PQ while requiring much less management than other IT system implementations I have been a part of.”
– Ed Reith, Supply Chain Engineering Manager, EBB

Medical device companies can leverage manual, paper-based, homegrown software, or purchased software QMS solutions. The FDA does not regulate what type of QMS solution is used. Regardless of the type of QMS solution used, companies must demonstrate and provide evidence, or validate that it meets the requirements to consistently deliver safe, high-quality devices to market.

One very important consideration when selecting any QMS solution involves the level of effort and ultimate cost to validate. QMS validation is considered an overhead cost required to satisfy the FDA and get products to market; it is not part of the material and assembly cost, since it is not directly related to producing the physical product.

Old Software, New Devices

Validating paper-based QMS or older on-premises and document-centric QMS software solutions is laborintensive, inefficient, and difficult. All this expense pulls valuable team members and resources away from product work. For companies using older types of QMS software, many find the validation process so punitive that they choose not to install software updates and miss out on many new feature enhancements as a result. For paper-based QMS, companies may reach a state of inertia, avoiding updating processes to improve product quality, delivery, or costs due to the burden of manual updates, validation work, and training. In both cases, medical device manufacturers face the daunting task of introducing cutting-edge devices and technologies using old, ill-fitting manual or software QMS solutions.

It is easy for a medical device company to focus excessively on system validation as they navigate considerable regulatory requirements and maintain a constant readiness to address audits that can result in FDA warning letters or adversely affect their business. In 2017 alone, the FDA issued 5,155 Form 483 findings across life sciences companies, and many of those were medical device manufacturers. However, driving design control process support based on fear of noncompliance may only delay time to market and increase costs.

The FDA recently recognized a lack of clarity in regulation requirements for system validation of software solutions. Furthermore, the FDA has launched initiatives to encourage companies to modernize for innovation, break down data silos, and adopt new technologies—in particular, moving to digital data and less burdensome compliance provisions.

As the FDA moves forward to embrace the world of technology and digital data, it stands to reason that medical device companies should as well. Cloud-based QMS software provides the best technology and capabilities for the lowest total cost of ownership and ease of validation. The type of cloud matters when considering computer software validation requirements—with a multi-tenant cloud solution, validation can be much easier to complete.