Cloud computing provides increased opportunities for more efficient business operations, collaboration and innovation, but regulatory concerns have been a challenge for life sciences organizations. The USDM Life Sciences Cloud Practice specializes in qualifying, validating and maintaining validation of Cloud solutions, helping customers meet FDA 21 CFR Part 11 requirements for the Pharmaceutical, Medical Device and Biotechnical industries and focuses on rapid deployment, improved quality and reduced / risk-based qualifications for all of our engagements.
We achieve this through:
- Being recognized as the leader in the life sciences cloud industry. USDM has set the standard for ensuring compliance with cloud technologies in FDA regulated industries.
- More than a decade of IT qualification projects, and industry experts in Cloud solutions including Salesforce.com, Oracle, DocuSign, Amazon and others.
- Risk-based approach to qualification – a tried and tested method where the focus of the qualification is on business critical functions that impact regulated systems data.
- USDM Cloud Assurance: Validation Accelerator Packs (VAPs) for best of breed Cloud technologies. These VAPs are a complete set of content-rich qualification and validation document templates for the system based on common, core requirements for life sciences companies.
The VAP difference:
Each USDM VAP lists requirements and tests for core system functionality and can be leveraged to build the qualification documentation suite. The USDM Life Sciences VAPs can decrease both validation time and qualification costs by 50%, as well as provide for faster implementation time and better system performance.
Among the common functionality covered in our Cloud Assurance VAPs are:
- Annual Vendor Audits
- SaaS Platform Qualification Plan defining the qualification strategy and deliverables
- System Requirement Specification (SRS) customized to single or multi-tenant platform configuration and operations based on an in-depth USDM pre-qualification audit
- Risk Assessment to address the basis for testing against the SRS requirements
- Trace Matrix to track the satisfaction of these requirements in the executed USDM IT Test Protocols
- Installation Qualification verifies the installed configurations and controls for:
- Data center facilities
- Server/storage/network infrastructure
- Software infrastructure
- Database infrastructure
- Operational Qualifications verify the:
- Operational processes (security, management/monitoring, procedures, personnel, training)
- System development and deployment processes
- Updated documentation with Seasonal Updates or Releases to maintain compliance.
- Updates available for annual Supplier Audits USDM, as required by FDA regulations and GAMP guidelines
- Available VAPs and automated testing tools for select independent software vendors to facilitate rapid re-validation of Cloud platform updates
Equipped with over 15 years of experience and specialization in regulated business processes, our skilled team of IT and Cloud validation professionals can provide your organization with innovative and streamlined options for moving to the Cloud.
USDM Life Sciences continues to add to the Cloud Assurance offering with these applications: