USDM’s Cloud Assurance is a managed subscription service delivering end-to-end GxP cloud compliance from implementation through ongoing validation maintenance of new releases.
Need continuous cloud compliance for your life science company?
If you are a:
- Medical device company needing product data integrated into a modern Quality Management System (QMS) to create more efficient workflows
- Pharmaceutical company needing clinical collaboration in a GxP compliant environment
- Start-up company with no IT resources from the life sciences industry who required Computer Systems Validation (CSV) expertise
- Biotech company needing to upgrade to a faster document management system (or enterprise content management system) to streamline collaboration through workflows and eSignature approvals
- Pre-commercial company, needing Digital Transformation Strategy and Roadmap to rationalize and consolidate applications, i.e., email, document management, file transfer protocol (FTP) servers and file share drives with a risk-based GxP compliance approach
- Company planning or undergoing a change due to M&A activity and need guidance or helping hands to support your consolidation with standardization and harmonization
Consider our end-to-end GxP cloud compliance service, Cloud Assurance.
Cloud Assurance provides customers a harmonized, continuous compliance experience across all their cloud vendors. With 20+ years of experience and thousands of GxP projects delivered, USDM’s team of regulatory and technology experts bridge the gap between quality compliance standardization and IT agile innovation.
Contact USDM to Talk About Continuous GxP Cloud Compliance
Validating GxP Systems with Cloud Assurance
Cloud Assurance is the leading digital assurance solution for life science companies.
- Quality auditors ensure your systems are continuously GxP compliant and ready for FDA audits, EU audits, or your local regulatory agency
- Cloud compliance methodology and toolkit successfully audited by regulatory agencies
- Reduce implementation and validation time
- Harmonize and centralize control of GxP cloud compliance
- Decrease the cost to manage cloud compliance
- Management of new releases for continuous cloud compliance
- Scalable vendor solutions to grow with your business and establish your compliant IT foundation
USDM’s Cloud Assurance is THE solution for continuous GxP cloud compliance
How does USDM ensure continuous compliance?
There are three distinct phases to Cloud Assurance: Vendor Audit, Implementation and Validation, and Continuous Compliance.
When a life science company, such as a medical device manufacturer or pharmaceutical company, works with us to ensure that they are GxP compliant, we start by auditing their current processes, technology, and manufacturing. We have a quality team of auditors that have conducted thousands of audits for companies internationally and apply a though approach and targeted, leaner approach in subsequent years.
Implementation & Validation
After we’ve audited your organization’s practices, we’ll come to you with a plan for implementing the GxP compliant changes, validate them, and accelerate your company’s digital assurance.
We’ll do things like:
- Part 11 and Annex 11 Assessment
- Create a validation plan
- Draft user requirements and functional specifications
- Risk and impact assessment
- Develop IQ/OQ/PQ protocols and test scripts
- Create, test, and train you on a traceability matrix
- Develop user and administration SOPs
- Deliver a validation summary report
Learn how USDM implemented Box GxP in less than 30 days for a pre-commercial oncology research company to accelerate their compliance readiness.
Continuous GxP Compliance
After our initial setup, audit, implementation, and validation, we’ll continue to work with you and your processes to ensure full GxP compliance. We’ll manage new vendor releases, conduct impact assessments from release notes, update validation documents, run automated regression tests, and provide the analysis and reporting.
Our process helps many companies, just like yours, to be more efficient, save resources, and accelerate the growth of their company and products. Our GxP validation services and continuous compliance management will help your company stay compliant since we keep abreast of the global regulatory requirements, continually looking to the future, e.g., validation of cloud-based solutions that leverage artificial intelligence so you can drive innovation. Learn how USDM built out custom validation applications using Salesforce GxP capabilities for a large medical device manufacturer with fragmented workflows and enabled 75% faster, more accurate approvals while decreasing IT licensing costs by $750k annually.
Download the Cloud Assurance overview to learn more: