Good Products, a provider of enterprise content management (ECM) solutions for the pharmaceutical, biotechnology and medical device sectors, has announced the addition of the new g-SOPs tool to its g-docs portfolio of document management solutions. This software tool facilitates the creation, management and storage of controlled documents related to Standard Operating Procedures (SOPs) for use in the life science industry.
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 life-cycle to meet the required industry standards. This can be costly and time consuming for organisations using traditional methods for document management, such as paper copies. In response Good Products has developed g-SOPs to streamline and standardise 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 centralised PDF rendering tool, which saves the user time by allowing the creation of 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.