Deviation Control — efficient solutions of Digital Life Sciences GmbH
The integrated software solutions by Digital Life Sciences GmbH offer you the digital implementation of deviations, as well as corrective actions and changes. The formerly paper-based process is now completely electronic for efficient deviation management. Learn more about our software solution for your deviation management.
What is deviation management (Deviation Control)?
Definition and overview
Deviation control is about the detection and recording of unexpected events or anomalies in the system or process flow. Deviation control also includes the analysis and classification of deviations. This is followed by the processing and correction of the errors or the creation of preventive measures. Sufficient documentation of the errors is one of the essential preconditions for correcting the deviations.
Errors can occur in numerous processes and systems. Not all of these errors can be corrected immediately, which is why it is also important to estimate the risk of an error remaining in the system. The Deviation Control derives certain measures for correction and elimination of the errors identified in the processes.
The main objective of deviation management is to define uniform countermeasures. In this way, a basis is created for correcting the errors and their impacts. Problematic situations must be identified at an early stage so that appropriate countermeasures can be defined and taken in good time.
Deviation, correction and change
Closely linked to deviation management are CAPA (Corrective And Preventive Actions) or preventive measures and Change Control (change management). The latter are measures aimed at ensuring that comparable deviations will not occur in the future.
If deviations occur, a deviation report must be prepared. However, this does not have to be an actual error. It may also be that the identified deviation is related to the test or production environment, or that insufficient data is available during testing.
In the narrower sense, deviations include technical errors, parameterization errors or programming that does not correspond to the concept. User errors or problems in the technical question are not considered deviations in the sense of Deviation Control. An error condition then corresponds to a task in Deviation Control if the error impact can be eliminated by measures such as CAPA or Change Control.
For a clear identification of the error it is important to document all relevant data modules and information exactly. This includes, for example, the suspected cause, reproducibility of the error or time of its occurrence. It is often possible to determine the severity of the error by means of certain characteristics. It is also possible to assess the possible impacts of the deviation in the medium and long term. Deviation management therefore defines the workflow over the complete life cycle of an error.
Within the scope of change management, the aim is to identify the impact of errors as early as possible. The earlier corrective actions are taken, the smaller the consequential errors and possible costs. The measures resulting from the analyses can relate both to the direct elimination of the deviation and to the control and continuous improvement of the processes, so that a repetition of the errors becomes unlikely.
Digital Life Sciences GmbH as a strong partner
The range of services offered by Digital Life Sciences GmbH provides integrated GxP-compliant solutions for your quality management. They range from Deviation control and CAPAs to change notifications and Change Control. The entire process runs digitally and spares you the need for paper-based measures.
Deviation management is also an integral part of the ECM system by d.velop. The system, which was specially developed for the life sciences industry, contains typical ECM functions and all relevant tools for document-oriented processes. With these and other solutions, d.velop is a powerful partner for numerous customers from the life sciences, pharmaceutics, medical technology, service sector and steel industry.
You have further questions about our software solutions? Please contact us, because we will be happy to advise you.
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