Optimizing Efficiency with Electronic Regulatory Submissions

A large generic pharmaceutical company has research, development, manufacturing and distribution operations worldwide including North America, South America, Europe, Asia and Australia.

This pharmaceutical company’s ongoing goal is to maximize return on investment in R&D by reducing the time required to develop and commercialize new products.

The company launched a number of strategic initiatives to accomplish this goal, including the implementation of Waters Laboratory Informatics solutions. Waters NuGenesis Scientific Data Management System (SDMS) plays a vital role in automating scientific information entry into the company’s Electronic Common Technical Document (eCTD) standard electronic format for regulatory submissions.

The eCTD is a new and advanced method used by pharmaceutical companies to assemble and submit regulatory submissions to any worldwide regulatory body, including the US FDA, Health Canada, Japan’s Ministry of Health, Labor and Welfare and the European Union’s European Medicines Agency.

This poses a unique set of challenges for electronic record and data management. Organizations must archive Information and records in a compliant, secure database that protects the integrity of e-records from tampering and loss throughout their relevant retention periods.

The challenge
The company requires an electronic solution that will provide information management capabilities that are superior to legacy paper documentation and workflow archiving. The solution must address a number of key business drivers, including:

• Secure new product exclusivity by optimizing the regulatory submission process.
• Response to regulatory and industry initiatives to implement common standards for e-submissions and e-information exchange.
• Maximize return on investment in R&D.
• Reduce product development and commercialization time.
• Increase productivity and efficiency while decreasing costs.

THE SOLUTION
The company selected Waters NuGenesis SDMS to be the cornerstone of its strategic initiative to establish a worldwide corporate information management, exchange and submissions information system.

The Electronic Regulatory Submissions project, initiated in 2001, employs an integrated software solution that combines several core applications:

• Waters NuGenesis SDMS: Automatically imports disparate data generated from instruments and outside sources into a centralized data warehouse. Information is searched, communicated and shared among scientists thereby facilitating laboratory efficiency, regulatory compliance and product development.
• Broadvision One-to-One Document Management System: Provides content management of business documentation in Microsoft Office formats and XML with e-signature workflow and integrated PDF and web publishing.
• Lorenz docuBridge: Combines content collected by NuGenesis SDMS and Broadvision in an eCTD document for submission.

The NuGenesis SDMS implementation began in early 2002. The first phase of the deployment concentrated on four North American sites and was completed in less than two years.

Of primary interest to the customer was utilization of NuGenesis SDMS’s Print Capture technology, which captures, indexes and secures the actual content of instrument-generated reports. The company relies on Print Capture for scientific data capture, metadata extraction and archival from a variety of data sources, including Perkin Elmer’s Totalchrom chromatography software, Agilent’s Chemstation and Chemstore chromatography software, LIMS and other supporting systems.

During the software integration phase, the Waters’ Enterprise Solutions group worked closely with a cross-functional team that included the company’s Corporate Regulatory Operation and IT departments. The Waters team provided post-deployment business and technical support as well as maintenance, incorporating critical feedback from the customer to ensure continuous improvement.

The successful validation of key software solutions is an essential component of any major deployment. The validation for this solution consisted of two stages: first, the core applications and second, the individual site-specific roll-outs. Timelines were seven months for core application IQ/OQ, and 4-11 months for IQ/PQ site-specific data configuration.

Business benefit
Waters NuGenesis SDMS now plays a vital role in handling scientific data entry into the pharmaceutical company’s Electronic Common Technical Document (eCTD) for regulatory submissions. By being the first to register and obtain approval for a new pharmaceutical product, a company receives six months of exclusivity and significantly enhances its revenue potential.

Moving to an all-electronic scientific and business information management strategy that facilitates workflow from laboratory scientists to final regulatory submission has yielded great gains in efficiency.

The availability of scientific data through NuGenesis SDMS has increased the company’s productivity and, combined with its single point of access for all information regardless of geography, has substantially reduced operating costs.

Finally, in an environment of increased scrutiny by international regulatory inspection organizations, the company has enhanced its competitive and strategic positions by improving its ability to readily satisfy compliance.

Collectively these benefits have allowed the customer to reduce product development and commercialization times.