Validation as a Service  (VaaS™)

Software Validation per 21 CFR Part 820 – VaaS™ is a dynamic FDA compliant software validation and quality system development service that addresses many compliance needs both inside and outside of Validated Cloud. This is an important pharmaceutical cost management service. We assist with software validation, validation maintenance, for software hosted with Validated Cloud or elsewhere. Validated Cloud provides audit preparedness prior to regulatory or third-party audits. Having Validation as a Service (VaaS™) helps plan budgets, keeps routine compliance activities current and act as the compliance liaison and trusted adviser. Validated Cloud has a library of quality system templates, validation templates and qualification scripts in our library and ready to use.

Validated Cloud’s VaaS program is in alignment with ISPE’s GAMP 5  soon to be released Computer Software Assurance guidance

Prepared Validation Packages and SOPs for Resale

Validated Cloud has prepared purchasable validation packages and SOPs. These documents are designed to expedite the validation process. These templates are ready customization to have intended use and can be aligned to your expected business processes.

Standard Operating Procedures Core Templates:

  • Computer System Validation
    • Policy for Computer System Validation Master Plan
    • Validation Strategy
    • Software Assessment Procedure
    • Risk Assessment
    • Required Documents
    • Configuration Design Specification
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • Trace Matrix (TMX) and Validation Summary Report (VSR)
  • Good Documentation Practices (GDP)
  • GxP Training SOP
  • Vendor Management and Assessment
  • Disaster Recovery Policy
  • Business Continuity Plan
  • Change Management
  • Data Backup and Recovery
  • Account management and Access
  • SAS® Usage SOPs
    • Programming Standards
    • Archiving Data
    • Statistical Reports
    • QC Validation

Validation Packages include:

  • SAS
  • R
  • Pinnacle 21
  • DocuSign
  • Veeva (various products)

 

GxP Auditing Services include:

  • SaaS vendors
  • GCP Audit
  • Medical Device Software
  • ISO 27001/SOC2 Internal Audit
  • GMP IT Audit
  • GMP Software providers

 

Contact Validated Cloud for a no obligation preview of these documents at info01@validatedcloud.com

Validation Plan

Validated Cloud can participate in or drive the creation of a validation plan. When purchasing a commercial application with a validation package, the time to a complete and running solution is cut dramatically.
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In-process Advice

Experienced Validation experts can be worth their weight in gold. Ask about experienced senior validation people available for your next project .
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Trace Matrix

After your validated application is deployed, have a Validated Cloud validation resource create a comprehensive trace matrix. This will help you find what you are looking for quickly.
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Audit

After your validated application is deployed, have a Validated Cloud validation resource audit your application validation paperwork to verify that there are no gaps between the application and Validated Cloud.
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VaaS Other Validation Services

Our Software validation team will work with your business to create User, Functional and System design specifications all the way through the IQ/OQ/PQ, SOP development and the Validation summary. Our Validation strategy is based on a traditional IQ/OQ/PQ framework commensurate with risk. Validated Cloud’s Validation team is highly flexible to the needs of your organization. We provide computer system validation resources for a one-stop-shop.

With purchased commercial software or in-house developed applications, the user requirements need to be fully developed to map to the PQ. Purchasing a validation package from a vendor can only get you partially through the process. An experienced validation person will be able to navigate you through the process effectively and efficiently.

  • Purchasing validation packages and Validated Cloud will greatly reduce the time and effort to deployment.
  • User Requirement development and corresponding PQ development are critical bookends that need experienced personnel.
The installation and operational qualifications can be separate or combined documents. These take the form of IQ, OQ or IOQ. There are advantages to separating the IQ and OQ, but it does create some overhead for document maintenance. VaaS™ will help you develop the IQ, OQ or IOQ framework. Once the user requirements are completed, VaaS™ will help you develop the PQ for the application.
Validated application deployments, migrations and upgrades should have a Quality plan. VaaS™ will help you develop the Quality plan. The plan should include the roles, responsibilities, controls, managing deviations, expected outcomes and how risk is managed. A well-written Quality plan and subsequent execution of the plan will defend the validated state of your application upon deployment.

  • Quality plan encompasses roles, responsibilities, control and assurance activities.
  • VaaS™ will assist you to integrate the Validated Cloud document package into your Quality plan.
One of Validated Cloud’s biggest advantages is the robust and developed SOP framework to manage all aspects of the infrastructure, servers, databases and other service platforms. Each customer receives its own SOP as part of a deployment. The customer SOP can include the support of the application and data. VaaS™ will assist you with the SOP development to manage your application and data.

Why Choose Us

      • Experienced staff from the Biotech, Medical Device and Pharmaceutical industries.
      • Experience deploying commercial and self-developed applications
      • Experience with upgrades and migrations