New facilities include enhanced audit trails and security controls to suit application in tightly regulated pharmaceutical laboratories
The pharmaceutical industry is one of the most tightly regulated in the world.
The audits carried out on pharmaceutical companies will scrutinise not only their laboratory procedures, but also any Lims systems in use.
Recent software enhancements to QSI's Winlims package provide additional tools to aid regulatory adherence.
Recently announced at the QSI European User Group meeting, held at the company's new European headquarters near Aylesbury, UK, these new facilities include enhanced audit trails and security controls.
The audit trailing logs every change made to a data record, be that changing a value, data deletion or any other modification, and also registers the circumstances of the change - who made it, when and why.
The security facilities enable comprehensive configuration of privileges, and include facilities like the detection of failed login attempts and monitoring staff training levels - so that an unqualified person would not be allowed to process a particular method, for example.
Also included is a facility for version control of specifications and methods, enabling precise identification of the quality controls that were in place at any time in the past.
The use of electronic signatures to authorise transactions is covered by the FDA's 21 CFR Part 11.
Winlims provides facilities for configuring and applying electronic signatures in excess of the regulatory requirement.
Other facilities for the pharmaceutical laboratory include the shelf-life testing option that holds user-defined testing protocols and informs the laboratory when to withdraw samples from storage for testing.
Formulation management, and complaints and corrective actions, are other tools that used with the Winlims core functionality, provide a unique solution for pharmaceutical laboratory without the need for extensive custom code.
