AssurX have launched a software process for document control, which will enable pharmaceutical manufacturing companies to streamline their approach to monitoring safety issues and overall quality control efforts.
The CATSWeb can assist manufacturers in improving their operational efficiencies by managing and distributing content, from change orders through to release approval, including procedures, datasheets and training programs.
This allows firms to improve visibility of process changes, reduce risk and labour costs associated with outdated procedures, and importantly, demonstrate regulatory compliance.
With recent high profile corporate compliance scandals being thrust into the spotlight, the ability to provide rapid access to current and accurate documents has become a critical industry issue, with new and updated industry and government regulations at all levels.
The US Food and Drug Administration (FDA) in particular has been active in issuing specific requirements for validation, audit trails, record retention, record copying, and legacy systems within manufacturing companies.
An August 2005 FDA guidance document stated that companies could significantly enhance their manufacturing decisions with effective, intelligent risk management policies.
The CATSWeb facilitates compliance with both FDA (21 CFR Part 11) and other regulatory requirements and standards such as good manufacturing practice (cGMP), international organisation for standardisation (ISO) 9000.
"The training component of CATSWeb is especially valuable because federal inspectors often examine an organisation's training programs, to get a feel for the level of control and discipline," said Sal Lucido, VP of Enterprise Solutions.
CATSWeb works by automatically maintaining a secure, time-stamped audit trail of all changes made to any electronic record.
It does this by saving a complete copy of the record to read-only archive tables immediately before a change is made.
Users making changes must enter a reason for their change, and this information is also securely archived.
The "view edit history" button appears with each record and may be used to view all past versions of the record; from the time it was created until the present.
The system therefore makes relevant content easy to locate, view, print, e-mail and download.
Based in the US, AssurX is a privately owned software company that has been operating for 13 years.