Deviation and non-conformance management software
To comply with GMP or ISO quality management system standards, you must have a process in place to manage deviations and non-conformances from written procedures and/or specifications governing operations. Our Ibiqs deviation and non conformance management software module automates and manages this process, supporting your compliance efforts and allowing you to collect and use data for continuous improvement purposes.
The Ibiqs deviation and non conformance management software module integrates with the other relevant components of the Ibiqs online quality management system (QMS) within SharePoint. This integration ensures a uniform response to each incident, for example deviations can be correlated to non-conformances and customer complaints because you have all the data in one place, allowing you to make linkages between the different modules.
The Ibiqs deviation and non-conformance management module allows you to find trends and patterns in the occurrence of deviations. This might trigger an investigation or launch a corrective/preventive action (CAPA) within the Ibiqs CAPA module if a pattern emerges.
Workflows and permissions
SharePoint offers an automated deviation routing, review and approval process, with email notifications for every step. This minimises the administration time spent on tracking and approving deviations and non-conformances. You can see at a glance who has a specific actions waiting for them – rather than hunting across the organisation for paper forms.
Management of deviations and non-conformances is necessary to comply with GMP or an ISO quality management system standard. By using the Ibiqs deviation and non-conformance management module, you can reduce the effort required at audit time as everything will be in the one place. You’ll also improve product quality and safety and increase customer satisfaction by being able to manage deviations and non-conformances with an efficient and compliant system. Ibiqs includes the features needed to achieve 21 CFR Part 11 compliance.
Forms within the Ibiqs deviation and non-conformance management module can be customised to suit existing workflows. Of course, we can provide best-practice advice on how to setup the forms and the workflows within your organisation, based on our extensive experience.
Ibiqs takes advantage of SharePoint’s extensive analytics and reporting capabilities to give you the metrics you need to monitor and improve your deviations management process. A dashboard will give you the key metrics – such as how many deviations have been raised in a specific time period. You can then drill down to get the breakdowns you need – by product or operational area. You can even schedule reports to be sent out automatically with exactly the data the recipient needs.
Access from anywhere
IBIQs is web-based so employees can securely login and access it from anywhere. You can also allow anonymous access via a form on a webpage, so suppliers or customers can submit information that automatically goes into the deviation management workflow, for example, if a raw material has been supplied that does not match specifications the supplier can upload documentation and data to support the investigation of the deviation.
Managing deviations within an electronic system makes it simple to respond to an auditor’s request for information about a specific deviation. You can show them the whole workflow and the documentation and data collected at each step, giving them confidence that your deviation management process works.