CAPA management software
CAPA focuses on the systematic investigation and remediation of issues in the manufacturing cycle. It is used to identify the root cause of problems and to implement actions to prevent re-occurrence. It is important that all information is accurately documented and any actions are reviewed and approved prior to being put in place so there’s an audit trail and organisational knowledge is captured. The CAPA management software module within Ibiqs has a Root Cause Analysis (RCA) process and links to other QA, Safety and business processes..
SharePoint’s advanced search functionality allows users to easily find the CAPAs they are looking for. This reduces user frustration as the number of documents grows and cuts wasted time from the task of trying to find the right one.
A good CAPA system is a GMP regulatory requirement and one that ISO auditors consider critical. By using a SharePoint CAPA system you can reduce the efforts required at audit time as everything will be in the one place (all your Quality documents, CAPA actions etc). . Ibiqs includes the features needed to 21 CFR Part 11 compliant.
Workflows & Permissions
SharePoint offers an automated CAPA routing, review and approval process, with email notifications for every step. This minimises the administration time spent on tracking, revising and approving CAPAs.
Forms within the Ibiqs SharePoint CAPA system can be customised to suit your 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.
The Ibiqs SharePoint CAPA solution integrates with the other relevant components of your QMS within SharePoint, such as change control, nonconformances and customer complaints. You can have a workflow that includes the systems you need to include so that nothing gets forgotten or falls between the cracks of having disparate systems to manage different Quality processes.
Access from anywhere
Do your CAPAs get held up every time the Production Manager travels? Ibiqs is web-based so employees can 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 CAPA workflow.
Imagine how easy it would be to respond to an auditor’s request for supporting documentation for a CAPA by clicking on the links in an online form instead of trying to find and retrieve documents from a manual CAPA system. Having an efficient CAPA system means less human resources are needed to support audits.
Ibiqs takes advantage of SharePoint’s extensive analytics and reporting capabilities to give you the metrics you need to monitor and improve your CAPA process. A dashboard will give you the key metrics – such as how many outstanding CAPAs there are and the average time since they were raised. Drill down to get the breakdowns you need – by product, department and root cause.