Beyond “Dumb”: Building a Paperless, Web 2.0 Validation Platform

Article by By Paul Thomas, Senior Editor, PharmaQbD.

“We are living in an era of ‘dumb’ content,” says consultant Nagesh Nama, President of ValiMation, Inc., and who spoke at DIA 2010 in Washington, DC. [Note: Nama's talk preceded that by Novartis' Jim McElroy, featured in yesterday's post on "The Paperless Validation

When Nama visits drug facilities, he sees that content is often “unstructured and uncontrolled, rarely reused, and extremely expensive to produce.” A typical scenario for asset management, for example, is one in which the asset information is not linked to validation entities,
whether for equipment, software, or process, and just getting the validation status of any asset can be time consuming.

Manufacturers’ validation document templates often do not provide “structure” to documents, though “structure is needed to turn information into knowledge.” Document development and reviewers spend a lot of time duplicating activities. Workflow automation for complete lifecycle management is either nonexistent or highly inflexible. Traceability is typically a manual chore that is time-consuming and costly. Finally, there is usually no workspace for team members to collaborate on regarding validation activities.

Nama, not surprisingly, is encouraging manufacturers to change. The essential elements of a good, paperless
validation program include:

The idea is that you should have a technology framework that helps you standardize,” Nama concluded. “And then you should be able to control it. Once you do this, compliance is an afterthought. It should fall in place.
  • Asset Management: You need to use some kind of technology infrastructure (such as Microsoft SharePoint), including an enterprise application (Maximo, SAP, etc.) to manage your assets. The asset database should be in synch with the paperless validation system.
  • Templates and Documents: The solution should have template and authoring modules (e.g., Microsoft Word plug-ins), and documents should be based on standard schemas, providing them with structure. These standardized templates provide structure and lead to the effective reuse of information assets, said Nama.
  • Paperless Executions: “It’s easy to do a paper-based execution,” Nama said, “but there’s absolutely no efficiency there.” A system should have a paperless execution module. 
  • Workflow: Business users should be able to configure their workflows to meet their needs. Traceability: You should be able to trace any document as you are developing it, he said. Changes should be updated in real time to ensure accuracy and cut down on version control problems. 
  • Collaboration: Collaborative workspaces and social computing tools (wikis, blogs, and team discussion boards) are essential for the paperless validation project, he said.