Your validation accelerator
In the highly regulated world of life sciences, validation is essential. Every system that touches GxP processes must be tested, documented, and proven to operate as intended. Yet, traditional validation is time-consuming, costly, and often delays system go-live.
Designed by industry validation experts, BPAMedical365® Validation Toolkit™ provides a complete set of pre-defined, regulator-ready validation deliverables that enable life sciences companies to establish a validated state quickly, giving you the confidence to deploy faster and stay compliant. All while reducing the total cost of validation.
The foundation for a compliant and cost-effective digital quality journey
Accelerate time to validation
Save up to 60% compared to manual validation efforts.
Ensure global regulatory compliance
Pre-aligned with FDA 21 CFR Part 11, EU Annex 11, and ISPE GAMP 5® (2nd Edition).
Reduce costs and complexity
Focus resources on your business-specific configurations.
Support continuous validation
Receive updated documentation after each BPAMedical365® release.
Flexible deployment options
A self-service accelerator or engage expert IV&V services for a fully executed, signed package
Build confidence with auditors
Demonstrate a structured, risk-based validation approach.
Built to jumpstart BPAMedical365 validation efforts
The foundation that accelerates initial validation and streamlines future re-validation following major software releases or configuration updates.
Each Validation Toolkit™ includes a complete, audit-ready documentation suite that spans every stage of the validation lifecycle, from planning through testing and summary reporting.
The toolkit provides:
- pre-populated templates
- predefined requirements
- ready-to-execute test scripts representing the system’s core, out-of-the-box functionality
Access additional resources for this solution
Quick Go-Live package
BPA's highly requested service package for a speedy implementation.
Our solutions are designed to be leveraged as much as possible out of the box, with preconfigured automated workflows for a quick go-live.
Gain full control over your QMS platform in just few days after a quick training of your power users for ultimate customization.
Our best value quick start package includes 24 to 40 hours of BPA Solutions senior consultant support for:
- software installation in the client tenant with automated workflow sets for the selected modules,
- out-of-the-box deployment,
- one or two configuration iterations,
- knowledge transfer to your power users,
- 1 hour training/configuration session weekly with your power users,
- go live in 3-4 months for your 2-3 priority modules.
This requires your power users to be available 10-20% during project implementation.