The current Global Automated Regulatory Database (cGARD) offers easy access to current global regulations, delivers flexible searching and reporting capabilities and enables rapid keyword searches based on industry-defined compliance subject areas.
The launch follows several pilot projects in which the system, according to the firm, was successfully used by a number of leading biopharm companies.
"The money a company will spend on the product will be saved in the first five or ten minutes it looks up regulations," said David Forrest, head of ComplianceControl, told In-Pharmatechnologist.com.
"All types of regulation are categorised in a single repository which is easy to use, so it basically does the work for you."The product is available on CD and can be installed on a laptop or desktop, or on an internal network, so anyone using it will have access to the latest rules and regulations.
It can also be obtained as part of the company's ComplianceControl Centre, a new software solution which allows real time control and visibility of compliance status in pharmaceutical manufacturing, providing a cost-efficient single on-line repository for all mission-critical compliance data and ensuring inspection readiness.
The Oracle-based software suite stores all critical validation and compliance data in a secure single database which is available and visible across an organisation with scalable levels of access.
The system tracks the status of projects, documents, systems, software, hardware, manufacturing and laboratory equipment, eliminating the time-consuming need for manually ensuring compliance.
All project risks, changes, minutes, issues and actions are visible in real-time as is an overall assessment of compliance.
What is more, major cost efficiencies are achieved via benchmarked standards that are established and maintained across the enterprise.
The centre displays key compliance indicators that are sector-relevant and essential for successful inspection and audit in a single, secure database that is visible to key players across the organisation, ensuring conformance, continued convergence and the use of correct terminology.