Good data management strategies in the biopharm industry

Victoria Lander, market development manager, for NuGenesis Technologies talks about the Part 11 regulations

European interest in the US Food and Drug Administration rule 21CFR Part 11, governing the use of electronic records, is growing daily. As requirement of the Rule, a drug therapy sold in the US must comply with its mandates. Therefore, laboratories throughout the world in the pharmaceutical and biotechnology industries must assemble and compile comprehensive reports for FDA submissions. This task to date has been a daunting and time-consuming chore for scientists. The need for a new strategy quite possibly stems from the realisation that the ability to manage scientific data in accordance with the practices described in Part 11 makes good business sense.

Compliance with Part 11 is long past the evaluation stage with IT managers at the world's leading pharmaceutical companies. One of the key challenges of this endeavour has been to compile and coordinate disparate data from a wide variety of sources. This data ideally must be assembled from multiple sites, then archived and utilised at one convenient location. The latter is extremely difficult to achieve with current resources. Following submissions, scientists may be also called upon to locate and re-address the data. Timely data retrieval is usually where most researchers get into trouble.

Part 11 does not govern any specific technology, but it has serious implications for all aspects of regulated operations. Every system that generates electronic records must be examined to determine its ability to comply with Part 11 – potentially affecting hundreds of systems within a company. This includes output from analytical instruments and from business applications, as well as LIMS (Laboratory Information Management Systems), MES (manufacturing execution systems) and others. Part 11 impacts the science-based organisation's operations both in the lab and across the enterprise.

While many suppliers to the pharmaceutical and biotech industries have enhanced their software features, and have also devised internal technologies to address the technical controls required by Part 11, such fixes tend to be proprietary and thus become only partial solutions. NuGenesis Technologies Corporation takes a unique approach to data management and knowledge transfer with its NuGenesis Scientific Data Management System (SDMS). NuGenesis SDMS unifies research data and business information from diverse data types and applications, placing these data into a secure, compliant repository.

The company has developed a program that systematises the collection, storage, retrieval and sharing of scientific data by unifying it into a common electronic format. Proper technical controls for Part 11 are also included. Scientists can capture data from a variety of lab and business application sources and store it in a central database, while maintaining its graphic integrity.

Users anywhere in the organisation can view the assembled data using a Web browser. This technology utilises an expandable, Web-based platform that integrates with multiple analytical and software systems to provide an enterprise-wide, compliant solution for data management.