Client Accolades:
"Validated Cloud’s comprehensive industry and compliance knowledge has yielded a dependable and secure hosting service." — David Restivo, Director of Information Technology at OPK Biotech
"The processes, documentation, and staff that support MUSA’s Validated Cloud allow us to have confidence that our production systems will function reliably, securely, and compliantly. We rely on MUSA for our critical systems so that we can avoid the costly setup of our own qualified IT infrastructure." — Jim Schweitzer, Director of Software Engineering Services at Vision Point Systems
"As to how you [Validated Cloud] stack up, very differently. Certainly, based on traditional approaches, your processes and approaches are quite sound." — Executive at a Top 5 Pharmaceutical Company
Specializing in Validated Hosting for the Following Industries:
Pharmaceutical
Biotechnology
Biomedical
Medical Device
GxP-Compliant Software Developers (SaaS) |
After years of successfully deploying compliance-bound internal clouds for its clients in the Life Sciences industry, MUSA decided to leverage its quality, validation and IT experience and deploy Validated Cloud. MUSA’s Validated Cloud is a private FDA-compliant hosting platform that started with compliance and is built specifically for the needs of the Biotechnology, Pharmaceutical and Medical Device industries.
While other companies have tried to validate other commercially available clouds, MUSA recognized that the industry required more comprehensive controls as well as an audit trail. For that reason, we deployed our platform under the control of a Quality Plan, thereby providing traceability back to the inception of Validated Cloud. Our Quality system development process started with defining our Functional Requirement Specifications and System Design Specifications. Our Validated Cloud is built and maintained in accordance with 21 CFR Part 820 and meets ISO 13485:2003 requirements for medical device quality management systems. According to our governing Standard Operating Procedures we observe an IQ, OQ and PQ methodology that’s commensurate with risk. All of our documentation is written in a manner that companies in our industry would expect to see, is entirely transparent and open for audits.
• Customizable solutions
• FDA audit-ready
• Avoid Form 483 Observation or worse
• Maintain control without worrying about the day-to-day
operations
Validated Cloud offers the full solution: Compliance Hosting, Managed Services, Platform, Application, Validation and Quality Support. We also offer a complete selection of á la carte services. Validated Cloud can also extend our service model to our customers’ sites. Whether your company has compliance systems in-house, or you host your systems in Validated Cloud, or even amalgamate the two models, we've prepared our Validation, Application and System support teams and trained them to provide a combination of onsite and remote support for GxP systems throughout their entire lifecycle. By leveraging the Validated Cloud support model, core IT can focus on their specialty - the enterprise – while Validated Cloud handles our specialty – compliance systems. Validated Cloud's IaaS/PaaS architecture becomes a hybrid cloud option for growth, Disaster Recovery and GxP system encapsulation.
To this day, we continue to refine and mature the subsequent versions of our governing Quality System, build out our hosting platform and deploy new production and DR/BC environments in other geographic regions. Our operations are transparent, open for audits and we are committed to compliance and security. We pride ourselves on being able to meet the regulatory challenges within the industry and provide a high level of service and value.
MUSA's Validated Cloud is powered by VMware.
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