Optimizing Efficiency with Electronic Regulatory Submissions

BACKGROUND

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. A number of strategic initiatives have been launched 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 data 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 regulatory bodies around the world, including the U.S. FDA, Health Canada, Japan’s Ministry of Health, Labor and Welfare, and the European Union’s European Medicines Agency.

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

CHALLENGE

The company required an electronic solution that provides 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
• Respond 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

SOLUTION

The large generic pharmaceutical company selected Waters NuGenesis SDMS to be the cornerstone of its strategic initiative to establish a worldwide corporate
information management, exchange and submissions system. The Electronic Regulatory Submissions project, initiated in 2001, employed an integrated software solution that combined several core applications:

• Waters NuGenesis SDMS: Automatically imports disparate data generated from instruments and outside sources into a centralized data warehouse. Information can be 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 TotalChromä chromatography software, Agilent’s ChemStationä and ChemStoreä chromatography software, LIMS and other supporting systems.

During the software integration phase, 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 four to 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. The ability to be the first to register and obtain approval for a new pharmaceutical product yields six months of exclusivity and significantly enhances 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 resulted in a substantial reduction in operational 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.

WATERS LABORATORY INFORMATICS SUITE OF SOLUTIONS
Waters NuGenesis SDMS is a part of the powerful suite of proven Waters information management solutions that improve how customers use key analytical results and knowledge to increase productivity and efficiency.

Waters Laboratory Informatics solutions unite all lab data sources– whether instrument or human – capturing, cataloging and making all scientific content accessible, from chromatograms to spectra to chemical structures; from the inception of your top innovators’ ideas to the intellectual property proof used to support patents.

The range of Waters software products includes:

• Empowerä software for chromatography data analysis
• MassLynxä software for advanced mass spectrometry Computation
• Analytical Workflow Manager for online management analytical lab processes’