The quality management module in SPECTra, ensures every action is completed following predefined processes. Documentation is therefore easily and securely accessed throughout the LIMS and completely eliminates the need for a paper chase.
Provides an easy and intuitive way of managing SOPs.
Operators are able to view all the SOPs on-line and alongside the applicable section.
Reminders can be set so that the Responsible Person is notified of when an SOP is due for review, etc.
The Document Management facility is an information portal for all types of documents, not just those subject to formal change control.
Providing the benefit of a closed and fully auditable system.
Out of Specification (OOS)
Provides electronic management of the investigation of a result outside the parameters.
The findings are maintained within SPECTra, can be reported at any time and are progressed to CAPA, if applicable.
Corrective and Preventive Action (CAPA)
This module is designed to solve problems quickly, minimise the impact of discrepancies and reduce the chance of re-occurrence.
CAPA process in SPECTra ensure corrections, cause analysis and preventative actions are all recorded effectively.
Electronically manages any deviation from the established procedures using pre-defined forms.
Allows for efficient and consistent data capture along with immediate corrective action.
Allows users to control changes to manufacturing processes.
Changes can be drafted, reviewed and accepted by authorised users.
Notifications in SPECTra improve communication to users throughout the facility.
They can be sent directly to a user or group, automatically generated in relation to an event or scheduled in the system.
Notifications are very flexible and can be used for a variety of reasons including reminding people of certain tasks, communicating group messages and operational alerts.
Any function can be analysed over time. This may be to look for variations in instrument performance or any other parameter such as synthesis yields.