In February 20001, Thermo LabSystems announced its acquisition of Galactic Industries Corp., the spectroscopy software specialist. Given Galactic's expertise in handling data from a wide range of analytical instruments and Thermo LabSystems' position in LIMS and solutions for chromatography, the subsequent launch of a new product for electronic record-keeping and knowledge management could have been anticipated. Reaction to eRecordManager product presentations has been one of surprise both in its broad functional coverage and its ability to make the actual data truly independent of the original application and computing platform.

As its name suggests, eRecordManager is a solution for the management of electronic records. The 'eRecord' aspect refers to 'Electronic Records,' as defined in 21 CFR Part 11. The 'Manager' aspect refers to Knowledge Management and the ability to share all this information across the organization.

Much of an organization's analytical data is required to be stored for a lengthy period to comply with regulations such as Part 11, or to be used as evidence in potential patent infringement or intellectual property protection cases. eRecordManager meets the requirement for long-term secure storage of spectral and chromatographic data from multiple types of instrumentation (such as GC, LC, MS, FT-IR, NMR, UV-Vis, Raman, NIR) and multiple data formats, while eliminating the reliance on the original instrument software, operating system and hardware to search, restore, view and manipulate the data.

Industry observers are estimating that the current five-year instrument product life cycle may compress to as little as two to three years. This means that over the 10 to 15 years of a drug development process, a company might go through three or more instrument models, each with its own data acquisition and control system, and often with its own file format. Data that was created ten years ago might still be needed in ten or fifteen-year's time to resolve questions of product liability or regulatory compliance. This poses the problem of archiving so many data file formats and ensuring they remain easily accessible to search and restore for the lifetime of the electronic record. Lab managers would welcome the opportunity to dispense with legacy computer and software systems so they can access archives of proprietary, binary data file formats.

eRecordManager incorporates a library of over 160 powerful file converters that automatically generate XML (eXtensible Markup Language) versions of the original data. The archived information can be viewed and reworked on virtually any platform long into the future, effectively future-proofing a customer's data.

What's the regulator's view on file conversion?

"Comments on the Proposed Rule"

Section III, Part 69 of 21 CFR Part 11...

"The agency agrees that providing exact copies of electronic records in the strictest meaning of the word ''true'' may not always be feasible. The agency nonetheless believes it is vital that copies of electronic records provided to FDA be accurate and complete. Accordingly, in § 11.10(b), ''true'' has been replaced with ''accurate and complete....

The revision should also reduce the costs of providing copies by making clear that firms need not maintain obsolete equipment in order to make copies that are ''true'' with respect to format and computer system."

Furthermore, in its recently published draft guidance document (docket number 00D-1539), the FDA discusses the issue of migration in the management of electronic records. This has arisen to supplant the alternative requirement of maintaining the whole computing platform (hardware, operating system and data system) for each type of analytical data as a sort of 'time capsule' solution, in order to render it accessible for the lifetime of the electronic record. FDA has stipulated that electronic records must be both "accurate and complete" to achieve compliance, therefore any migration process that involves conversion or normalization of the data must have these qualities.

Why adopt XML as the converted file format?

There are many aspects in favor of XML, including:

$ba It is publicly-available; managed by the not-for-profit World Wide Web Consortium (W3C).

$ba Being both self-describing and open ASCII text, XML-based files are essentially 'future proof'.

$ba Public-domain schema for specific data types are used to guide its use and against which documents can be externally validated.

On this last point, when storing instrument data in XML, eRecordManager utilizes a public-domain schema known as Generalized Analytical Markup Language or GAML. The schema, and additional information on the GAML data format, can be downloaded by visiting www.gaml.org.

To satisfy the long term record keeping requirements of FDA, eRecordManager archives both the original raw data files from the instrument software, along with the normalized representation in GAML.

Users with access to the eRecordManager archive can view the normalized version of the data from any computer. In addition, either the GAML or the original data files can be retrieved for use with other software applications, though the latter relies on the original software and hardware being available.

Knowledge Management and 'Web Services' Spectra and chromatograms are the fundamental units of data upon which calculated results and subsequent conclusions are based. Putting this data into one place in a common format such as GAML provides the ability to data-mine, compare and visualize instrument data that is so vital in improving R&D productivity. As global drug discovery and development projects become the norm, requiring interaction from specialists around the world, this is particularly important.

The ability to easily access data from throughout the organization also aids the development of new ways of analyzing samples and predictive models that are impossible when the data is scattered across the company in individual instrument workstations. Access to past research avoids redundancies such as the repeating of work on identical compounds.

The use of XML, and schemas such as GAML, offers data intensive industries such as biopharmaceuticals, the opportunity to benefit from a new computing architecture known as 'Web Services'. Based on a combination of XML and HTTP technology, Web services are intended to enable the exchange of data between heterogeneous systems in human-readable, platform-neutral XML messages. Web services architecture represents an attempt to allow remote access of data and application logic in a loosely combined fashion; a need that is no greater than in the management of bioanalytical data.

As mergers, data sharing and communal resources become more accepted in the biotech and pharmaceutical industry, data compatibility and system integration become difficult, and often expensive, considerations. Here, web services can offer significant benefits. By using common schemas and transforming the information, data held in the different systems can be searched, queried and displayed via XML documents, using common interfaces such as a web browser.

A proteomics researcher could, for example, perform a keyword search for related samples, spectra, annotated sequences, and 2D gel images of a particular protein across multiple systems within an organization. This search could be performed from a page in the corporate Intranet or portal. Some portals offer organizations and users the ability to create a site that is personalized for individual interests; as such, a laboratory portal could be used to bring together sources, databases and functionality pertinent to a laboratory user. This might include access to analytical results, spectral and chemical information and even documents and procedures. Having a central access point for this type of information helps eliminate barriers between departments and functions, improves internal collaboration and communication, and ultimately delivers operational efficiency by making better use of internal resources and knowledge.

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