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(19 February, 2009) Good Products, a leading provider of Enterprise Content Management (ECM) solutions for the pharmaceutical, biotechnology and medical device sectors announces the addition of the new g-SOPs tool to its g-docs portfolio of document management solutions. This innovative software tool facilitates the creation, management and storage of controlled documents related to Standard Operating Procedures (SOPs) for use in the life science industry. A free-of-charge WebEx can be arranged by visiting www.goodproductsEU.com
SOPs are essential in order to ensure that all procedures are carried out in a consistent and fully compliant manner. Regulatory requirements for data are stringent and all documentation relating to SOPS needs to be securely stored and tracked throughout the entire lifecycle to meet the required industry standards. This can be costly and time consuming for organizations using traditional methods for document management, such as paper copies. In response Good Products has developed g-SOPs to streamline and standardize the creation, management and approval of SOPs in these highly-regulated sectors.
g-SOPs allows users to create and manage SOP documentation and trigger automated workflows including review and approval processes. Within g-SOPs, users can publish approved SOPs to the document library and access a full audit trail and complete document history. All SOPs and related documentation are securely stored within the g-SOPs module of g-docs.
The g-SOPs tool ensures full compliance with FDA 12 CFR part 11 guidelines by storing the full audit history for each document. Audit trails can be tracked and managed within the g-SOPs library for easy access during submissions to regulatory agencies. Document access is controlled, enabling administrators to determine which users can create, view and modify individual documents depending on levels of responsibility. Once approved, SOP documentation is published to a watermarked PDF format using AdLib Software's Express Server centralized PDF rendering tool, which saves organizations time by allowing users to create high-quality, FDA-compliant PDFs at the click of a button.
g-SOPs is a configuration of g-docs built on the Microsoft MOSS 2007 platform which is widely used in life science and pharmaceutical sectors, saving organizations time and money as fewer resources are required to implement this tool. g-SOPs can be quickly integrated into existing systems and is flexible enough to incorporate new workflows while requiring minimal user training. The g-SOPs software tool is operated within Good Products' g-docs, an electronic Document Management System (eDMS) that allows organizations in regulated environments to effectively manage, track and securely store increasing amounts of information and documentation, while being fully compliant with industry standards. g-SOPs can be integrated with additional data management features including g-train, Good Products' web-based Compliant Training Management system and ValMan, a fully compliant Validation Project Management tool.
For more information on g-SOPs, please contact SOPs@goodproductsEU.com. For further information on the Good Products' clinical trial consulting services, please visit www.goodproductsEU.com or email info@goodproductsEU.com