P&G faced problems managing the vast amounts of paper required for a company that develops drugs and over-the-counter (OTC) medications. Regulatory issues, research and development (R&D), and potential litigation generate even more paper documents and files. As a result, P&G wanted to gain control of its company documents, reduce administrative oversight of its paper documents, reduce costs, accelerate R&D initiatives, and improve tracking and signature compliance. P&G decided to adopt an electronic document management system.
When P&G moved to electronic documents, it had to ensure that it could authenticate digital signatures and build signing and storage processes into its daily workflow. Further, P&G’s legal department wanted to ensure that it had a legally enforceable signature on file.
The IT Solution
P&G turned to IT integrator Cardinal Solutions (www.cardinalsolutions.com) to implement Adobe LiveCycle Reader Extensions and Adobe LiveCycle PDF Generator (www.adobe.com), which would function with P&G’s eLab Notebook program. These software packages would manage, review, approve, and sign the huge volume of R&D information, including files created with Microsoft Word, Excel, and PowerPoint.
P&G adopted the pharmaceutical industry’s Signatures and Authentication for Everyone (SAFE) BioPharma Association standard. This standard was established to help companies go paperless and still interact with regulatory authorities on a global scale. P&G’s initiative focused on implementing methods to manage digital signatures and creating a method to confirm the identity of the signer. The company’s IT and legal departments agreed that the standard met the company’s business needs and risk requirements.
Instead of recording information from experiments in paper notebooks – along with numbering each page, signing it and having a witness sign it – researchers can now use word processing programs, spreadsheets, presentation...