A GxP compliant cloud-based Maximo® as a Service (MaaS) solution ready for client validation
✔ Projetech Automation Following Good Manufacturing Practices for Life Sciences
✔ Variability Removed from Routine Complex System Management Activities
✔ Certified Maximo Experts Trained in cGMP Protocols
✔ Four Client Dedicated Environments
✔ Reliable and Secure Cloud Solution
✔ Established Change Management Practices
Increased Validation Burden
The biggest fear is that a cloud-based QMS will require frequent upgrade, and therefore, frequent validation. In fact, it’s just the opposite. Frequent upgrade means smaller, faster and easier validation.
Loss of Control
Life sciences companies are used to controlling their systems. They equate on-premise system with full control, while they equate cloud-based system with loss of control. The cloud, just like an on-premise system, allows users to have access to their data whenever they need it. They control the access to it.
Commingling of Data
Life sciences companies, most of which own proprietary information, are afraid to share a platform with other companies. They fear the commingling of data. While some delivery models risk commingling, choose a model that allows data seclusion.
This is another myth because the degree of security vulnerability, whether on-premise or cloud, depends on the technology used to secure data and the strict enforcement of security protocols. Cloud providers usually have dedicated security teams to protect the platform. Also, a frequently updated system will always have the latest security patches.
Fazzi, Cindy. “4 Common Fears and Misconceptions About Cloud Validation.” GxP Lifeline, 2019, www.mastercontrol.com/gxp-lifeline/4-common-fears-and-misconceptions-about-cloud-validation/?source=n3w5quality.
MaaS for GxP is built on our Maximo as a Service framework. You still get all the great benefits of Maximo as a Service.
Highly available system; 24x7 monitoring; best practice back-up, restore and disaster recovery service; Maximo® as a Service remains available via a URL even if your place of business experiences a disaster
Projetech is an ISO/IEC 27001:2013 certified provider whose Information Security Management System (ISMS) has received third-party accreditation from the International Standards Organization.
Emergency support from a live resource; established change control procedures including client communication; coordination with clients on timing of Maximo® system maintenance downtime; client approved Maximo® system patches and upgrades
A large existing Maximo® client base across multiple industries and multiple countries.
Pay-as-you-grow model scales the solution to match load and usage of the Maximo® application with a user subscription-based model
Removes variability from complex routine activities e.g., installations, upgrades, license compliance reviews, year-end processing option
Fast highly available systems on continuously upgraded infrastructure.
One stop service for standard Maximo® solution components including software, middleware, database, reporting, support, operating system, infrastructure, system monitoring, integrations, and mobility
Maximo® license entitlements; client can optionally “bring your own license” (BYOL)
Services from an experienced solution provider with IBM certified Maximo® experts