Requirements Traceability for Web Based Software

Our calibration management system is designed for ease of use.

Operator using the GMP CMMS system GxPReady! Suite to enter an equipment record.

As a user of validated CMMS software systems that are available on line, one of the challenges is how to verify that the software has been validated to meet YOUR specific requirements and demonstrate traceability to those requirements. GxPReady! Suite was designed and validated in a manner that allows traceability to your requirements using our patented Flash Validation(TM) system.  So it is easy to see how the system meets YOUR requirements, should you be audited.  More importantly, you can have confidence that your requirements have been met so that you won’t have issues come up when you use the software for its intended use for your calibration, validation, or maintenance scheduling.

Tracing YOUR requirements for the system to the testing should be as easy as possible, and is MUCH more relevant than meeting whatever requirements the vendor may have in place for the software.

If there are any gaps between your requirements and the validation of the system, they can be managed up front, so that you don’t have any surprises as you continue using the product.  In the end, you can feel confident that you can show a reviewer YOUR requirements, and the testing that supports that the requirements have been met, without going through a confusing array of documents.  Furthermore, our standard documentation package (which is included in the low price) provides much of the information to a reviewer and indicates where any additional support documentation is available.

In this way, we aim to provide the most economical, traceable, and convenient validated CMMS system available, including compliance with EMEA (including Annex 11) including FDA (including Part 11) requirements.

When deciding between validated software systems, look at your requirements document and select one of YOUR requirements. Ask the software vendor where that requirement is tested in the validation package.  If they have the validation package available, it should only take a few minutes to see the applicable testing.  During an audit, minutes count, and so does the ability to clearly communicate traceability.  Flash Validation(TM) gives you an edge with that important aspect of compliance!