Despite state-of-the-art IT systems and sophisticated business processes, the volume of paper that assaults the typical enterprise is overwhelming. And nowhere is the problem worse than for companies developing drugs and over-the-counter medications. Regulatory issues, R&D and potential litigation stack up to an avalanche of documents and files.
“Paper is extremely cumbersome and unwieldy,” says Kay Bross, senior public key infrastructure specialist for Procter & Gamble. “Plus it’s expensive and time-consuming to manage.”
As a result, Cincinnati-based P&G is attempting to eliminate paper and migrate to a system that allows it to store R&D information electronically, while managing secure digital signatures. The consumer goods giant—with $76.5 billion in 2007 sales and a portfolio that includes Crest, Tide, Gillette, Pampers and Charmin—aims to gain greater control of documents, reduce administrative oversight, trim costs, accelerate R&D initiatives, and improve tracking and signature compliance.
About 320 employees are now using P&G’s system, which runs on Adobe LiveCycle software and employs two-factor authentication. The company hopes to roll out the application to more than 4,500 workers by the end of 2009.
“The idea is to create a searchable archive of PDF files and a common set of tools for the enterprise,” Bross explains. “People must be able to use the system globally and have access to key documents on an instantaneous basis. Seamless interaction is essential.”
The migration from paper to pixels has flummoxed more than a few companies. The task can involve major changes to workflow and create enormous challenges related to approvals and compliance.
At P&G, any possibility of slowing an already complex R&D process and interfering with the approval and introduction of a product could wreak havoc on the bottom line. For example, a successful over-the-counter medication can generate sales of upward of $1 million per day.
Typically, researchers, clinicians, quality-control staff, marketing specialists, and dozens of other internal P&G staff and external partners must exchange and share documents. In the past, storing all those documents meant stuffing filing cabinets internally, producing microfiche, managing indexes and renting warehouses to store reams of documents off-site.
“Digging through all the records is a long, laborious process,” Bross notes. “If a court case comes up, the process of pinpointing a document and pulling it out is extremely time-consuming and painful.”
Not surprisingly, the perils of paper have exacted a toll. In the past, some indexes weren’t entirely accurate, and manually searching for a particular section of a document—or associated documents—devoured even more time. And outsourcing records management had its own problems. In one instance, a London warehouse operated by an outside service provider burned to the ground, and P&G permanently lost hundreds of boxes of records.
Although P&G has considered migrating to an electronic record-keeping system for the last several years, Bross and other executives felt that key pieces weren’t in place at that time. After all, the company had to ensure that it could authenticate digital signatures and build signing and storage processes into its everyday workflow.
In addition, P&G’s legal department wanted to be sure it had a legally enforceable signature on file. Designing an electronic system with paper backups was too expensive and didn’t offer an adequate return on investment.
Then, in 2005, all the pieces began to fall into place. That’s when P&G embraced the pharmaceutical industry’s SAFE (Signatures and Authentication for Everyone) BioPharma Association standard. It was established to help companies go paperless and still interact with regulatory authorities on a global scale. The initiative not only focused on ways to manage digital signatures, it also created a method to confirm the identity of the signer.
SAFE “was the only digital signature approach that offered an identity-proofing scenario,” Bross says. “It provided a legally enforceable component within the overall liability framework.”
P&G’s IT and legal departments examined the initiative and agreed that it met the company’s business needs and risk requirements.
Today, once a digital signature is added to a file, an auditor can examine it in a tracking bin or view a validation report. It’s immediately possible to view all the activity related to the document.
“You simply right-click on the signature and view the entire audit trail,” Bross explains. “The signature can also be exposed and appended as a last page of the file so that it can be shared appropriately on an external basis, such as in a court of law or if there were a sale of the product.”