During the ISPE 2017 conference in San Diego earlier last week it was interesting to see how open the industry is to using the Software as a Service (SaaS) model for GMP applications, compared with just a few years ago.
ISPE has recently published guidelines related to such applications in order to promote good practices in the development, deployment, and documentation of GMP SaaS applications. These guidelines support the validation of cloud based systems in their various forms for GMP use.
These guidelines provide some of the advantages of the Flash Validation technique used by GxPReady! on our GxPReady! Suite software but there are still advantages to our process in that we can get our customers up and running even more quickly than the generic model. With GxPReady! Suite, customers can have GMP Calibration Software, GMP Validation Software, and/or GMP Maintenance Software ready for GMP use in days.
There is useful information in the new ISPE guidelines about the challenges of SaaS implementation for GMP software and due diligence recommendations for companies planning to use such systems. These include reviewing the capabilities of providers to ensure good internal practices with code development, security, risk assessment, requirements traceability, operational procedures, qualification documentation, etc.
GxPReady! Suite was developed from the ground up as a SaaS application using internal procedures over the years that meet requirements for Good Manufacturing Practices, 21CFR11 and UE Annex 11. We are excited that the industry is moving in the direction of SaaS and look forward to helping additional customers with their GMP Calibration Software, GMP Validation Software, and GMP Maintenance software needs with our secure, robust, and compliant software at a fraction of the cost and time investment of traditional solutions, and even other SaaS options. Our system is deployed on our proprietary Qualified Private Cloud (QPC) system with solid security and compliance features. We encourage companies to investigate SaaS and cloud-based solutions to their Calibration, Validation, and Maintenance scheduling needs as an upgrade from legacy, spreadsheet, and/or calendar based solutions to improve the compliance, workflow and reliability of their operations while reducing cost and resource expenditures.