FDA Validation

Companies in the pharmaceutical and health care industries require more of their Enterprise Business Solutions than their counterparts do in other industries. Often, the first question asked would be--- Is this system FDA validated?

FDA validation is critical to assuring product quality for software automated operations. Furthermore, software validation is a requirement of the Quality System Regulation, 21 CFR Part 820. This requirement applies to any software used for manufacturing, labeling, packaging, distribution, complaint handling or any aspect of quality management. Such software may be developed in-house or under contract, but it is most likely to be an ERP system purchased for a particular intended use.

BPI Technologies understands that deploying an ERP system is simply not enough for our pharmaceutical clients. During all phases of deployment, we focus on mission critical results including 1) Business and IT objectives, 2) Class A processes and 3) FDA validation. We document the requirements that fully define the intended use of the ERP solution, and against which testing results and other verification evidence can be validated. We understand the complex subject of software validation. Through our work with the FDA, we recognize that although software validation may sound like software testing, the FDA uses this term to encompass the entire software development lifecycle.

As a result, our successful approach includes both structural and functional validation. Structural validation ensures that:

• Software logic has been developed to perform in accordance with the functional specifications.
• The software performs in an efficient, concise and reliable manner.
• All logic paths are complete and terminate logically.
• Single entry and exit points have been used.
• Programming and development standards have been incorporated.

Functional validation ensures that:

• Testing is performed without regard to source code logic.
• The software satisfies its intended use.
• Data integrity is maintained.

Our clients know that the benefits of software validation are significant. Validation can increase the usability and reliability of the ERP software to streamline processes, resulting in decreased incident reports, fewer recalls and/or corrective actions, and reduced liability.

Supply Chain Management

During the 1990’s, customers redefined the way they wanted to do business and began to demand products and services to fit their own schedules, 7 days a week, 24 hours a day. In response, a number of the best multinationals broke away from competition by optimizing their supply chains with information technology to satisfy this emerging business model.  

Before most organizations could even adapt to the emerging business model, it changed again. Ground breaking research by the BPI Research Center in 2000 proposed a new business model for life science companies----a supply web rather than chain. 

Today, the Internet is redefining the supply chain into a supply web and creating a brand new business model. At BPI Technologies, we leveraged our pioneering work on Strategic Enterprise Solutions and the BPI Research Center to develop what we envision as the new emerging business model, as shown below.

Emerging Supply Web Business Model---Ground breaking BPI research 

Driving this model are several factors including:

1. The ability of customers to shop for the best price, quality and delivery of products and services real time on the Internet.
2. Venture capitalists’ investment in e-commerce organizations.
3. Supply chains moving on-line.
4. The economics driving management decisions to outsource manufacturing operations.

In our opinion, companies will either adopt this new business model to their advantage or cease to exist.  Our pioneering work plus years of experience has made BPI Technologies a recognized leader in the integration and optimization of every aspect of the emerging supply web.