LONDON, UK / ACCESS Newswire / September 16, 2025 / isoTracker has added a new stand-alone CAPA module which continues the gradual upgrade of the isoTracker QMS software product which started in 2024 and will continue on a module-by-module basis over the next 12 months.

This is an important upgrade which moves the CAPA records away from the modules they were integrated with, such as Complaints and Non-Conformances, into a new stand-alone CAPA module that still integrates with those modules plus offers many new features.

As isoTracker can be subscribed to on a module-by-module basis, the upgrade has been implemented to current and new customers who only want CAPA but also those who want any combination of the Document Control, Complaints and Non-Conformance modules. As other modules are upgraded, customers using those upgraded modules will then be upgraded. So this is an incremental process spread over 12 months.

The addition of a stand-alone CAPA module introduces the following important new features:

• A new stand-alone module that still interacts with the other modules. So a Corrective Action can be recorded from a Complaint or a Non-Conformance and then assigned to different people and be closed at different times.

• Ability to be used for Root Cause Analysis (RCA) using the 5 Whys, 3 x 5 Whys, 5 x 5 Whys or Fishbone methods.

• Can be used to record a Corrective Action (CA) and/or a Preventive Action (PA) directly from a Root Cause.

• Can be used to identify the most appropriate CAs and/or PAs using the built-in task notification feature. Escalate when not acted upon.

• Ability to validate the agreed upon Corrective Actions and/or Preventive Actions using the task notification features.

• Ability to require approval of the validated CAs and PAs prior to implementation. Use Electronic Signatures for Approval to confirm identity.

• Automatically set CA or PA Implementation Target Dates with reminders and escalations.

• Automatically set CA or PA Effectiveness Target Dates with reminders and escalations.

• Can be used to evaluate the Effectiveness of the actions by using the built-in task notification feature. Escalate when not acted upon.

• Can require a Final Review approval before closing. Then use Electronic Signatures to confirm the closure of the CAPA.

• Automatically, remind the closing user if a Root Cause or Non-Conformance does not have a CA or PA.

isoTracker's new stand-alone CAPA module provides an easy to use structure for identifying issues, investigating root causes, identifying corrective and preventive actions, verifying them prior to implementation, implementing them and, finally, evaluating their effectiveness. It also meets the electronic signature requirements of 21 CFR Part 11.

"We have always prized ease-of-use and affordability. This important addition adds additional flexibility, a new look and feel while at the same time improving its ease-of-use." said Christopher Stainow, Director of isoTracker Solutions Ltd.

A 60-day FREE trial of the isoTracker QMS software product can be requested on their website.

SOURCE: isoTracker Solutions Ltd