New software to ease regulatory document burden

By Nick Taylor

- Last updated on GMT

Good Products and Adlib Software have teamed up to create a streamlined and compliant regulatory document management system for the pharmaceutical industry.

The partnership will integrate Adlib Software's Express Server centralised PDF rendering tool with Good Products' electronic document management system (eDMS), g-docs.

Pharmaceutical organisations using the software will find it easier to store, manage and track regulatory documents, according to the creators. In addition the software can create regulatory submission-ready PDFs with bookmarks and hyperlinks.

Peter Duff, president and CEO of Adlib, said: "Our partnership with Good Products complements the ability to provide compliant document conversion systems to the pharmaceutical industry​.

The integration of g-docs and Express Server accelerates regulatory submissions and enables organisations to manage documents in a compliant way across the whole lifecycle, from creation to regulatory submission​."

Good Products’ software g-docs is capable of tracking a document’s version history, managing approvals, monitoring and recording changes in an audit log.

It also incorporates CoSign, a digital signature that has been held up as valid in the US’ courts. This is an aspect of being compliant with FDA 21 CFR Part 11, which issues guidance on electronic records and signatures.

Adlib Express Server complements g-docs by automatically converting different file types such as scanned images, engineering drawings and web and image formats to PDF. In doing so the software also meets the standards set by regulatory bodies.

g-docs also uses Express Server to maintain audit, version, reference and distribution tables within the rendered documents.

The companies are looking to collaborate on more products to offer the pharmaceutical industry the benefit of their complementary skills sets.

Keith Williams, CEO of Good Products, said: "We are now looking to work together to develop further enhancements and functionality, enabling deeper integration of Good Products and Adlib Software solutions​."

More companies opting to integrate software

Proxeon has integrated its EASY-nLCT software with Thermo Fisher Scientific’s Xcalibur, making it a registered Virtual Instrument Partner (VIP).

EASY-nLC, a system used for liquid chromatography-mass spectroscopy (LC-MS) applications in proteomics laboratories, has been integrated with Xcalibur, which is a mass spectrometry data system.

Proxeon claims users of the integrated software will be able to control the system and output chromatography data directly into the Xcalibur software for further analysis.

Related topics: Regulatory & Safety, Lifecycle Management

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