By Paul Thomas, Senior Editor

At DIA 2010 in Washington, DC, Novartis Consumer Health process development manager Jim McElroy presented a case study on his facility’s move to a paperless cleaning validation environment.

McElroy works at NCH’s Lincoln, Nebraska site. “We have scores of API’s and hundreds of development trains, so it became very difficult to maintain [cleaning validation records],” he said. “Our validation effort was managed by maintaining Excel spreadsheets to collect and store data. This required a great amount of human resources.”

Before the Lincoln site went to a paperless system, for example, a typical risk assessment might take two weeks, McElroy said, whereas now it is usually a matter of an hour or two.

Cleaning validation is rules-based, McElroy noted, taking into account the solubility of the API, its difficulty to clean, and toxicity. “Assessing risk is the norm,” but previously the data mining required was performed with spreadsheets.

Therefore, Novartis configured its own cleaning validation software, based on Microsoft’s SharePoint. Software is a means of enforcing “standard work,” McElroy noted, and provides large databases that can be automatically researched. Risk can be managed efficiently across the team.

One of the features of the tool that was built is referred to as “entity management,” which McElroy described as “a repository of all the API’s, solvents, cleaning agents, equipment, cleaning procedures and analytical methods. The entities can be created, edited, approved, and retired.” Rules have been defined to link one entity to another—for example, a piece of equipment with an API.

Some of the validation components that have been facilitated by the system:

Cleaning validation assessment: Rules have been established to ensure only entities that have been approved are used for performing an assessment, he said. But there is the ability for the operator to override the recommendation and action item provided by the tool.

Cleaning validation protocols: “These are form-based paperless protocols for API residue verification, cleaning agent residue verification, and microbial verification,” McElroy said. This step eliminates the process of reentering data for the protocols, saving time and money.

Protocol execution: The system has a paperless execution mode using web-based forms for each protocol type. Formulas are in place to determine the result (pass/fail) for every executed step.

Workflow: Almost every feature of the system has a workflow, each of which is configurable, McElroy noted. The workflow types can be saved in a single depository.

Collaboration: One of the most important features of the tool is that it’s very collaborative, he said. The collaborative aspect is provided by SharePoint, as well as wikis, blogs, and other social media tools.

Concluding, McElroy advised the audience to define processes to better manage risks. “Well-defined processes can be managed by software such as SharePoint, and risk management is consistent across the organization.” The benefit of doing so: “This allows your most valuable assets, your people, to focus on value-added functions.”

A Now a Word from Our Vendor
McElroy’s presentation was followed by one by Les Jordan, CTO of Microsoft’s Life Sciences group. Jordan reminded audience members that they already have many tools by which to automate their validation records. “When it comes to validation and maintaining validation records, you have your choices of platforms to put them on,” he said. “Your companies own a plethora of these tools.” Jordan cited Documentum, OpenText, Bioclinica, NextDocs, and Qumas (which announced a strategic partnership with Microsoft at DIA) as solutions/vendors that integrate with SharePoint.

Jordan, naturally, promotes SharePoint as the document management platform of choice, and noted that the 2010 version has numerous new features aimed at facilitating paperless environments within the life sciences. One function is an improved integration with other systems, making it possible, for example, for a company that uses Documentum to integrate it with SharePoint for its broader document needs.

Another key feature of SharePoint 2010 is cross-browser capabilities, meaning that those accessing the system can use IE, Firefox, or numerous other browsers. Finally, Jordan noted that 2010 has improved metadata management functions, digital signature features, and improved 21 CFR Part 11 compliance.

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