Validation Support
Complete validation documentation and support for Computer System Validation (CSV) under GAMP 5 guidelines.
GAMP 5 Approach
BioWise follows the GAMP 5 (Good Automated Manufacturing Practice) guidelines for validation of computerized systems. We support a risk-based approach that focuses validation efforts where they matter most while providing comprehensive documentation for all requirements.
BioWise Software Classification
Configured product—commercial off-the-shelf software configured to meet business requirements.
Validation Lifecycle Support
Planning Phase
Define validation scope and approach based on system risk assessment.
BioWise Provides:
- • System description document
- • Supplier qualification documentation
- • Risk assessment templates
- • Validation plan templates
Specification Phase
Document requirements and system functionality.
BioWise Provides:
- • Functional specifications document
- • Configuration specifications
- • Data flow documentation
- • Integration specifications
Verification Phase
Test and verify system meets requirements.
BioWise Provides:
- • Installation Qualification (IQ) protocol
- • Operational Qualification (OQ) protocol
- • Test scripts library
- • Traceability matrix
Operation & Maintenance
Maintain validated state through controlled changes.
BioWise Provides:
- • Change control documentation
- • Release notes for updates
- • Regression test documentation
- • Periodic review support
Validation Documentation Package
Provided by BioWise
- System Description Document
- Functional Specifications
- Installation Qualification (IQ) Protocol
- Operational Qualification (OQ) Protocol
- Traceability Matrix
- Release Notes
- Security Configuration Guide
- User Administration Guide
Customer Responsibility
- User Requirements Specification (URS)
- Validation Plan
- Risk Assessment
- Performance Qualification (PQ)
- Validation Summary Report
- SOPs for System Use
- Training Records
- Periodic Review Documentation
Note: BioWise provides templates and guidance for customer-responsible documents. Our validation team can support your efforts with consulting services if needed.
Validation Services
Self-Service
Access documentation package and templates for internal validation teams.
Included in all plans
Guided Validation
Work with our validation team to execute IQ/OQ and review documentation.
Professional & Enterprise
Full Validation
Complete validation service including URS development and PQ execution.
Enterprise add-on
Validation FAQ
How long does validation typically take?
For a standard implementation, validation typically takes 4-8 weeks depending on your organization's processes and the scope of testing required. Our guided validation service can help accelerate this timeline.
What happens when BioWise releases updates?
All updates include release notes and regression test documentation. For major releases, we provide updated IQ/OQ protocols. Minor updates typically require abbreviated testing based on the change scope.
Can we audit BioWise?
Yes. Enterprise customers can conduct supplier audits. We provide access to our development processes, quality management system, and security controls. Remote and on-site audits are available.
Is BioWise suitable for GxP-regulated processes?
Yes. BioWise is designed for GxP-regulated environments including GMP, GLP, and GCP. Our compliance architecture addresses 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity requirements.
Ready to start your validation?
Our team can walk you through the validation documentation and discuss your specific requirements.
Request Demo