The U.S. Food and Drug Administration has created a complex regulatory regimen to ensure the safety of products offered to consumers. It also helps mitigate the risk for manufacturers by mandating that they adhere to these stringent requirements.
Making the Right Choice
The enterprise software selected for manufacturing medical devices and pharmaceutical products is of paramount importance and can literally be the difference in achieving success in the highly regulated consumer product marketplace.
It’s important for manufacturers to understand the distinction between verification and validation of software technology as defined by the FDA. Software validation is an increasingly important consideration for industries covered by FDA regulations, especially as technology automates what once were manual, paper-based processes.
The FDA describes software validation as accomplished through a series of activities and tasks planned and executed at various stages of the software development lifecycle. The typical lifecycle model includes functional areas like quality management (QM), system requirements definition, software design specifications and many other steps, including retirement of the software.
For example, in the quality management function, the FDA requires validation processes for electronic signatures, recall/hold functionality, serialization/lot control-traceability features, non-conforming reporting (NCRs), corrective and preventive action reports (CAPAs) and calibration and test functions.
However, validation is only required when the software functionality potentially affects the safety of the end user.
Regulations Rule
Serialization and supply chain security regulations were put into place in 2013 with the passage of the Drug Quality & Security Act (DQSA) and Drug Supply Chain Security Act (DSCSA) requiring pharma manufacturers to be able to trace the entire lifecycle of their products. The DQSA outlines steps to build an electronic system to trace prescription/compound drugs as they are distributed domestically. The DSCSA was enacted to facilitate traceability throughout the supply chain. Combined, they provide a critical foundation for fighting against counterfeiters and enabling full recall capabilities.
An interesting complexity is the need to collaborate across complex, global supply chains and work within patient privacy rules. What’s important for a successful collaboration is effectively and accurately managing data and related documents which is where an integrated quality management and/or document management solution will be indispensable.
Software Validation Protects the Manufacturer and Consumer
Software validation is a critical tool for assessing the quality of technology and software automated operations. Forces such as product development, time-to-market, traceability, quality management and compliance all factor into a dynamic set of market conditions. Properly deployed, ERP technology solutions can increase reliability while reducing failure rates, recalls and corrective actions.
Validation also contributes to the solution’s longevity and viability. Systems that undergo successful validation are less costly to reliably modify when required and prove to be helpful when revalidating software changes when the solution is revised.
As innovation and the sophistication of technology increases, so does the risk for non-compliance. Keeping abreast of regulatory requirements is crucial for medical device and pharmaceutical product manufacturers.
Verification ensures that products, services or systems meet defined requirements.
Validation: Are We Building the Right Product?
That’s the key question for pharmaceutical, medical device and biotech companies when it comes to validation and it is a nuanced but significant difference from verification. Validation is defined as “the process of evaluating software during or at the end of the development process to determine whether it satisfies specified business requirements.”
Validation ensures that the product meets the user’s needs and that the specifications were correct in the first place.
Verification: Are We Building the Product Right?
That’s the question that companies in highly regulated industries must answer. Verification is defined as “the act of reviewing, inspecting or testing, in order to establish and document that a product, service or system meets regulatory or technical standards.”
The objective is to ensure that the product is built according to the requirements and design specifications. Verification ensures that products, services or systems meet defined requirements.
How to Analyze and Assess the Best Solution
Companies in highly regulated industries must rely on the efficacy of their ERP solutions for the company’s health, much like their end user patients relay on the quality and effectiveness of the pharmaceutical products and medical devices they produce. Validation and verification requirements applies to software used by companies to run their operations as well as the software embedded within products for end user use.
ERP and quality management systems can help meet domestic and global regulatory requirements. They can manage the scheduling of certifications and calibration of equipment when required and track the results to ensure compliance with all requirements.
Managing business risk is directly related to the organization’s enterprise systems going through a software validation and verification processes.
Partnering with an independent third party focused on technology software solutions and adhering to an ERP selection criteria helps avoid any false starts or implementation failures.
David Saunders has more than 25 years of business experience helping mid-sized and large manufacturing and distribution companies improve their operations and underlying business processes. Dave began his career with Kraft Foods and spent 10 years working extensively in distribution and logistics, as well as sales and operations planning. Additional experience includes Manager of Logistics and Planning for a global electrical supplier, Director of Business Processes at a major international manufacturer of tape and other adhesive products, and Director of IT Governance for a $19B global leader in consumer and industrial products. Dave has a BS in Management from the Krannert School of Management at Purdue University and an MBA from the University of Illinois-Chicago.
