Wyeth Pharmaceuticals is one of the world’s largest pharmaceutical companies, with a host of products in such areas as women’s healthcare, infectious diseases, gastrointestinal health, hemophilia, oncology, vaccines and more. Knowledge management solutions are critical to the firm’s success in several different parts of the complex process of researching, manufacturing and delivering those diverse products to market.
In order to meet current Good Manufacturing Practice (cGMP) guidelines, the company must produce validation documentation for its manufacturing equipment that details temperatures, tolerances and other specifications about certain machine and process operations. cGMP guidelines call for standard manufacturing controls and quality as determined by the FDA and other regulators.
Validation process
To meet those cGMP requirements, Wyeth has historically developed validation documents for each specific piece of equipment. But the process was inefficient, according to George Skillin, senior director in Wyeth’s Central Engineering and Packaging Services organization.
The company would start each validation document, nearly from scratch, with initial material containing some of the necessary information, then would add more information and develop a document that covered the intricacies of many different models of the equipment. The final validation documents would run 100 to 150 pages, and require certain sections to be lined out based on the equipment being validated. That would often lead to execution errors in the documents, causing rework and additional reviews.
"It’s a huge amount of documentation," Skillin says. Company users knew the documentation was necessary to meet regulatory requirements, but also knew that the legacy process was cumbersome and expensive in terms of time and manpower.
So Wyeth wanted a more efficient way to handle the documentation. The firm looked at a few different solutions before running a pilot using Virtify’s Enterprise Structured Content Management suite. "It had the broadest features of all of them," Skillin says.
Resourceful reuseThe Virtify application breaks documents down into separate components, which allows users to assemble documents in a dynamic way based on certain business rules, and to make them specific to the piece of equipment being validated. Wyeth employees can then utilize those small elements of reusable content to build new content, much like software developers can use components to build new applications rather than starting from scratch every time.
The company took some example legacy documents and fed them into the Virtify application. The new validation documentation is about 30 percent shorter than typical validation documents, and reduces the actual document production time significantly, according to Skillin. After the successful pilot, the company is examining using the application across other areas of the organization.
"We’re projecting a 40 percent reduction in the time it takes to assemble this type of documentation, and we see many other potential uses for this application," Skillin says.
Analyzing legal bills
As a large, worldwide pharmaceutical company, Wyeth works with some 350 law firms to meet its complex legal needs. For several years, the company had separate systems for legal management and for electronic billing.
While those systems provided some efficiency because they eliminated much of the paper of older systems, as separate applications, they didn’t provide the easy analysis needed for the company to manage its legal costs, according to Dexter Carpenter, Wyeth’s director of law financial operations and systems.
"We were looking for an integrated package that would provide management and e-billing," Carpenter says. "With the different applications, we couldn’t drill down into the related matter information during bill review. It required going between two separate applications when reviewing bills."
Consistent billing
So when it was time to upgrade its legal management system last August, Wyeth chose TeamConnect with Collaborati Spend Management, an integrated electronic matter and billing management system from Mitratech.
By being able to review the bills and legal issue management in a single application, Wyeth can easily compare billing from different firms to help ensure that similar matters are billed at similar rates. Claudio Crisafulli, Wyeth associate director, information systems, says, "This way we can see what is reasonable and customary."
The system automatically flags and returns non-compliant invoices. If a bill appears to be outside the norm, Wyeth has a basis for renegotiating the bill without the time and expense of a human reviewer. Carpenter says, "We let the system handle the flagging for us."
TeamConnect can also accept a wide variety of bills, saving the law firms the time and expense of converting the bills into specific formats, which will help companies bill Wyeth electronically.
IP invoicing
"Our legacy e-billing vendor had a cost structure that made it difficult or impractical for the smaller firms that we do business with to submit invoices electronically," Crisafulli says. So, the company still had a large number of paper invoices.
