MaaS for GxP

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

4 Common Fears and Misconceptions About Cloud Validation

• 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.

• Security Vulnerability

  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.