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Philip Morris International Inc. (PMI) is an American global cigarette and tobacco company with six of the world’s top 15 international brands, including Marlboro – the number one cigarette brand worldwide. PMI sells its products in more than 180 markets.
As a document management platform for its R&D department, Philip Morris used the Documentum products suite: Webtop, Fulltext engine and rendering engine. Application usage and changes in regulatory compliance needs showed the strengths and weaknesses of that configuration and, after careful analysis, the company decided to continue investment in the EMC Documentum platform by modernising and rationalising it: removal of unused and deprecated features; clinical documents submission and publishing; security model improvement; and compound document support, amongst other elements.
At the same time, our client wanted to use this opportunity to validate their future architecture against 21 CFR part 11 and Modified Risk Tobacco Products compliance rules.
Support clinical documents publishing and submission.
Validate solution architecture foundation to accelerate future release delivery.
Enhance the existing Documentum data and security model.
Provide complete documentation to ensure the qualification of the solution with GxP requirements.
We proposed a solution based on Documentum D2, an intuitive and configurable content-centric client for Documentum. The main benefit of this approach was to capitalise on the existing PMI Documentum platform and competencies.
We began the project by providing some recommendations for upgrades to the existing platform and by defining the disaster recovery strategy policies. Then, we created detailed technical specifications and a solution design based on the customer’s user requirements.
The project construction phase was divided into three parts. The first consisted of D2 product configuration using an iterative methodology based on the detailed technical requirements. In the first iteration we delivered common content management functionalities: the technical foundation. Next iterations focused on functional requirements for each of the business units. We executed a total of 12 iterations, one for each business unit. The project’s second phase was a Documentum platform upgrade. We delivered a full Documentum and D2 qualified platform, and reusable components for future Documentum-based projects. Then third phase focused on quality assurance. Using our field experience in validated environments, we provided all of the deliverables expected by the qualification of the solution in collaboration with Philip Morris’ IT and QA teams.
We are currently working on new business functionalities: document publishing and records management.
We developed and used a certified EMC solution called SmartMigrate for the Documentum data migration. This tool supports configuration-based document migration. Build on top of the D2 user interface, business users define the migration rules and the tool is responsible for its execution.
This project delivered a validated Documentum platform configured and documented following GxP quality guidelines. Now, future Documentum applications will benefit from this investment. As the platform is validated any applications delivered with it are automatically validated, which represents significant time and cost savings for the organisation.
The application we delivered covers the requirements for 12 business units sharing a set of common features, including data models, workflows, lifecycles, and security contexts. The use of this common core will now significantly reduce development time for future needs.
We defined a dynamic security model based on document properties and on user roles to guarantee appropriate access to documents. We adapted this security model for each business unit and it can be extended with ease.
We defined the application to provide a role-based interface: users see tonly he workspaces and functionalities to which they should have access to. This user interface simplification improves user productivity.
