The Challenges of Life Science Software Validation: InfoStrength s Key Differentiator

Transcription

1 The Challenges of Life Science Software Validation: InfoStrength s Key Differentiator

2 The Challenges of Life Science Software Validation: InfoStrength s Key Differentiator By: Russ King, President, MethodSense, Inc. The Problem/Opportunity Most companies thrive when their business operations are optimized. Regulated companies differ from their unregulated counterparts in that they are saddled with the challenge of complying with mandates from regulatory bodies, which adds an additional layer of complexity to life science businesses operations. Life science companies must not only operate within the framework of applicable regulations, but must also be able to quickly and effectively demonstrate their compliance. As a result, life science enterprises, especially small to medium sized companies, increasingly turn to software solutions as a means of streamlining their business processes and demonstrating compliance with FDA regulations. Unfortunately, they face two key challenges in doing so: Cost: Most business and document management software solutions currently available are expensive. The barrier to entry, from a cost perspective, is often too great for most emerging, and many established, life science companies to overcome. Traditional solutions require the upfront purchase of software or software services, extensive implementation and customization cycles, and a significant cost/resource structure associated with ongoing maintenance and support. Most young life science companies operate on razor-thin budgets and cannot afford the capital expenditures required to support this model. Validation: The practice of software validation is a distinguishing characteristic of the life science industry. The FDA requires any software that touches the regulated process be validated. This software must be tested and managed in a way that demonstrates it performs as intended by the end user. Companies using software subject to regulatory oversight must be prepared to demonstrate that the software, and associated hardware, is developed, utilized, and maintained within a framework of controls that meet regulatory demands and expectations that reflect values such as integrity, authenticity and non-repudiation. Adding an even greater burden to this challenge is that re-validation must be assessed any time there is a change to the software (e.g. patch, upgrade, etc.) that impacts the software's validated state. Otherwise, the company must correctly justify, on a risk basis, that validation is not needed. Software revalidation must be assessed every time there is an upgrade, patch or change.

3 While the concept of software validation may be complex, its impact is not. The average life science company spends months and typically tens of thousands of dollars to validate software solutions. This is in addition to the initial cost to acquire and implement the solution. Needless to say, validation is a burden that is difficult to overcome for many, if not most, life science entities. What You Need to Know about Software Validation The FDA requires life science companies to validate software when that software supports regulated processes, such as GxPs, or are subject to other Title 21 regulations (e.g. 21 CFR Part 11). Below are some key items to keep in mind: Any software used to automate any part of the production of your product or any part of the quality system must be validated Computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are subject to validation requirements Even if software is purchased off the shelf, you must ensure that it will perform as it s intended Any change in configuration requires you to revalidate your software, or justify why it doesn t need to be validated again Updates, patches and new features send you back down the validation path How the Market Currently Handles Validation Software vendors catering to FDA regulated markets today will either pass the burden of validation onto the client or assist the client with their validation strategy to some extent. Vendors who pass the burden of validation onto the client are quick to acknowledge that the FDA requirement to validate a software solution is the client's obligation. While they would be correct in making this claim, their answer seeds doubts about their commitment to the life science industry. Alternatively, many vendors who promise validation assistance do so at significant cost, typically in the form of a project where they provide the client with temporary staffing for validation development and execution. Other vendors create sample validation documentation and sell it to their clients. However, all too frequently, such vendor documentation lacks the critical detail required to meet the baseline expectations of regulators or fails to capture the actual way in which the client uses the software. Consequently, clients often find themselves in the midst of significant validation projects even when a validation "package" is made available by the vendor. Choosing to not validate your software puts you at risk for costly setbacks. Life science companies then have two choices: undertake the extensive and expensive process of validation or risk the consequences of operating a non-validated software solution

4 within their enterprise. Neither option is particularly appealing. The Unique Value Proposition of InfoStrength The MethodSense leadership team that developed InfoStrength Smart Enterprise Suite is comprised of both regulatory experts and technologists. They have developed software regulations and audited operations for multiple industries and various companies across the globe. They have a unique understanding of how software should be developed, configured, and implemented to meet the stringent requirements of regulated environments. Additionally, the company is conscious of the fiscal constraints under which life science companies must operate. MethodSense uses this knowledge to deliver the following key differentiators with InfoStrength Smart Enterprise Suite software: Integrates both regulated and non-regulated business processes InfoStrength delivers functionality that is traditionally found in 8-10 unique and disparate software applications. The InfoStrength software bridges the chasm between regulated and non-regulated business processes. Moreover, it does so in a fully integrated manner providing unparalleled insight into and control over the operating environment. This approach is far superior to alternative solutions from both a cost and operational perspective. Provides a pre-validated solution and a fully validated and controlled environment The unique expertise of InfoStrength s creators, coupled with a world-class software development process, assumes the burden of validation for its customers. InfoStrength s solutions incorporate regulated controls into the software, and the company provides its clients with the comprehensive documentation regulators require. The approach saves its clients months of effort and tens of thousands of dollars. Eliminates need to re-validate software during configuration The unique architecture of InfoStrength enables life science enterprises to configure the software to meet their individual business processes without requiring re-validation. As we know, validation must be performed whenever any change to a software application impacts the validated state of the software. Because all of InfoStrength s capabilities have already been validated, including the administrative functionality that enable solution configuration changes, additional validation is not needed when a client expands functionality. Removes cost barrier by delivering the solution through the Software as a Service (SaaS) model For a monthly fee, InfoStrength clients leverage the comprehensive capabilities of its solutions directly through a simple web browser. This model eliminates the high upfront and ongoing costs of traditional software. There are no capital expenditures for servers, software code or the need for high cost IT expertise. Implements in days and requires very little end-user training The company s SaaS architecture enables clients to be up and running on the solution in a matter of days. Additionally, the intuitive design of the user interface and functionality requires end-users to complete only a simple training curriculum in order to achieve user competency.

5 Closing Thoughts Regarding Software Validation Whether you choose InfoStrength as your document management solution or software from another provider, you will be required to thoroughly validate your product. With InfoStrength, our regulatory experts have done the heavy lifting for you, providing you with a validated software solution uniquely tailored to the compliance needs of your life science company. If you have validation needs for another software, know that our team has deep knowledge of your requirements. Our goal is to help you get compliant and stay compliant. What InfoStrength Clients Say * The key to our success is execution. InfoStrength SES is a strategic component to executing our business plan. President and CEO InfoStrength has saved us hundreds of thousands of dollars. Founder InfoStrength can be used to coordinate between departments, manage critical information such as IP and SOPs as well as support our due diligence efforts. VP and Co-Founder * Client references available upon request. About MethodSense, Inc. MethodSense, creators of the regulatory document management software InfoStrength Smart Enterprise Suite, is a Life Science consulting firm that helps clients deliver medical and technological breakthroughs by effectively meeting the requirements needed to bring their products to market. We guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions. Our guidance enables clients to operate more effectively during the commercialization process and beyond. MethodSense is located in the heart of Research Triangle Park, North Carolina home to one of the world s largest biotechnology clusters and a hub for technology-based innovation. We invite your communication: Russ King, , rking@methodsense.com,