Signature Meets Signature Regulations with ApproveIt

Signature Pharmaceuticals, a division of American Generics, Inc. (Gloverville, NY), was having problems with—you guessed it, signatures—the handwritten kind that must appear on every document associated with the regulatory approval of a new product. Signature, which has produced and distributed generic versions of various prescription cough syrups and hydrocortisone creams since 1989, recently constructed a state-of-the-art liquid manufacturing plant. Through this new facility, the company has been better able to meet demand for its products by offering a new and expanded line of generic liquids that includes both prescription and over-the-counter cough syrups. But the one thing the new facility did not do was improve Signature's signature problem. In fact, it made them worse.

Before the FDA introduced its rule on electronic signatures and records (21 CFR - Part 11, allowing the use of electronic documents and signatures in regulated processes) in August 1997, Signature, like other drug firms, endured the paperwork supporting what many believe is a cumbersome, time-consuming approval process. Still bounded by "wet ink" signatures to approve their documents, the company faced the management of increasing numbers of documents, the inability to retrieve documents quickly, as well as document loss. Signature was slowly losing its ability to keep documents current, as papers were shuffled from one person to another to obtain signatures. To top things off, Signature didn't have enough space to store all the paperwork.

Signature found itself inundated with several hundred forms, including Validation Protocol drafts, GMP drafts, SOP's and Certificate of Analysis reports that required manual signing. Those who had to sign documents were often located in different parts of the building, which required the forms to be hand-carried from person to person. This time-consuming process significantly slowed down the product development process.

In October 1997, Signature completely automated their approval process by replacing handwritten signatures with ApproveIt electronic approval software from Silanis Technology, Inc. (St. Laurent, Quebec). By accessing password-protected files in which authorized signatures had been saved for repeated use during the approval process, ApproveIT enabled Signature Pharmaceuticals to meet the FDA signature regs. Shortly thereafter, in July 1998, the company was audited by the FDA and became the first regulated pharmaceutical company in the United States to implement electronic batch records and electronic signatures into their existing protocols. As a result, the company achieved its ultimate goal of significantly shortening the time to bring their products to market.

After implementing ApproveIT, Signature employees could easily and efficiently sign and authenticate forms. By creating an all-electronic environment, the company has increased their ability to manage documents and streamline the entire approval process. Additionally, by moving forms electronically through email and providing shared access to forms in a database application, the "carry documents from one part of the plant to another" was eliminated. "We realized significant time savings when we completely stopped moving, storing and retrieving paper," commented Ravi Chandran, president of Signature. "ApproveIT's electronic signature has allowed us to complete the approval process in one-fourth the time. Every employee uses a password to log on to their computer. Since ApproveIT uses a password protected system as well, training time was minimal as we were already familiar with this concept." Chandran claims his company has saved "countless" hours because ApproveIt required no reengineering of their business processes.

ApproveIT appears as a pull-down menu within Microsoft Word, so workers can sign documents within a familiar environment. "We were already working with Microsoft Office in an established Windows NT environment," Chandran stated. "In order to go electronic, the only thing missing was an electronic signature."

Of extreme importance to Signature Pharmaceuticals was ApproveIT's batch authentication function. It is not uncommon for the company to have up to 60 signatures on one document. For example, during the development of a new cough syrup, each time a new ingredient is added to the product, three signatures must be added to the document. During a lengthy approval, the task of physically looking for any changes made to the document along the way was very tedious and time consuming. Using ApproveIT's authentication feature, Signature is now able to detect instantly if changes have been made to one, or any number of, documents.

ApproveIT's built in audit trail and time and date stamp allows the company to verify who signed the document, when it was approved, and log the details of every signing event that occurs during the document approval process. The most current documents are now always at their fingertips and they have a complete approval history of every document. "With ApproveIT, we always know who signed the document and when the approval took place. We are able to easily track the events that occur during the signing cycle," Chandran said. "This is invaluable in FDA processes that could potentially be audited."

For more information: Tracey Ades, Marketing Manager, Silanis Technology, Inc., 3333 Cote Vertu, Suite 305, St. Laurent, Quebec H4R 2N1 Canada. Tel: 888-745-2647. Fax: 514-337-5258.