R&D/Regulated IT - Tactical and Strategic Services
MUSA’s highly-trained professionals support the Life Sciences and understand the compliance needs and complexity that surround GxP Application support. We fill the gap between corporate IT and the compliance needs for the Line of Business (LoB). To bridge the gap between core IT and the sciences/manufacturing, we’ve built upon our tactical support services and developed a framework for calibrating this specialized subset of IT support and service delivery with the long-term strategic and operational vision of our clients’ scientific requirements.
| • Application Support
|| • Lab Services Program
| • Staff Augmentation
|| • Operational Consulting
| • Projects and Analysis
|| • Service Structure Consultation
Since its inception, Validated Cloud has been built under a formal Quality plan. Our FDA-compliant hosted offering is put together in a way that Biotech, Pharmaceutical and Medical Devices companies would expect to find in their own computer system validation framework. Documentation standards, which include an IQ, OQ, PQ, change control and SOP methodology, are designed to control operations and focus on proper risk assessments for change. Presently, MUSA continues to refine its governing Quality System and build out its hosting platform in accordance with 21 CFR Part 11, 21 CFR Part 820, and ISO 13485:2003 regulations.
• Fully qualified FDA 21 CFR Part 11 Compliant Hosting
• Deployed and Maintained under a Formal Quality System
• Securely Encapsulated GxP Systems
• MUSA Supports the Compliance, Platform and Applications
• Open For Audits
• Transparently Operated