Product category:
Data management software
News Release from: Good Products | Subject: G-docs
Edited by the Laboratorytalk Editorial
Team on 26 February 2008
Document management shown at DIA's
Euromeeting
Good Products, a provider of Enterprise Content Management (ECM) for the pharmaceutical and biopharmaceutical industries, has launched G-docs electronic document management
G-docs is designed to help life sciences organisations cope with increasingly complex regulations and growing amounts of information It will be showcased at the 20th DIA annual Euromeeting, 3-5 March 2008 in Barcelona, Spain
This article was originally published on Laboratorytalk on 18 Dec 2006 at 8.00am (UK)
Related stories
Winlims rental pays for itself
Cost savings achieved by the introduction of Winlims to a typical laboratory easily exceed the monthly payments required under the new Winlims Rental scheme
Integrated analytical QC at heart of Lims
"The quality control systems on other Lims systems are passive in nature. This means that users do not realise there has been a problem until after all the results have been entered"
G-docs offers life sciences organisations a regulatory compliant, effective, easy-to-use way of tracking document version history, manage approvals, monitor and record changes in an audit log.
Additionally, it incorporates CoSign, a digital signature that allows an individual to digitally sign a document as if they were using ink.
CoSign digital signatures have now been upheld in the US court, and are deemed to pass the 'non- repudiation' test as well as being compliant with the FDA's 21 CFR part 11 guidance.
Further reading
Stability trials and results managed by Lims
Particularly useful for busy laboratory staff in the pharmaceutical and food industries who can now enjoy the benefits of their stability trial and results being managed entirely by their Lims
Make spreadsheets compliant with Part 11
Solution provides 21 CFR Part 11 compliance controls to Excel spreadsheets by adding logical security, a secure audit trail, and the ability to apply electronic signatures
CoSign can also be easily integrated into G-docs and indeed any digital format that can be printed can be 'signed' using CoSign.
The full pharmaceutical document lifecycle is controlled within G-docs, using a simple browser interface but with full audit trail of user logon and changes to any documents.
eDMS is already used by large pharmaceutical organisations, however the software purchase price added to configuration, validation and implementation costs are prohibitive for small to mid-size companies.
G-docs is built on the commonly used Microsoft SharePoint platform and Moss 2007.
By using an existing platform and configuring tools and modules specifically for the pharmaceutical and biotechnology markets, Good Products says it reduces the amount of original software development required, resulting in a more cost-effective and regulatory compliant product.
Additionally, the product requires less validation as the core modules are validated as they are built and stored in a secure repository and integration testing is done to the specific customer's requirements.
This also means that the customer benefits from having G-docs match their regulatory and QA document processes not ours.
Good Products has already built corrective and preventative action (Capa) and deviation management modules, and is in the process of building Validation Document management and regulatory risk management modules to add to the standard G-docs platform.
Product training is minimal as many users are already familiar with Microsoft already and once G-docs is implemented, department heads have the ability to configure future libraries, templates and workflows.
Administrators can also manage document retrieval, site construction, and document retirement using the tools we have configured for them.
• Good Products: contact details and other news
• Email this article to a colleague
• Register for the free Laboratorytalk email newsletter
• Laboratorytalk Home Page
Search the Pro-Talk network of sites
