Validated ALM and test management
Still running validation on paper and spreadsheets? Move validation off paper and into a validated ALM or test management tool. We set it up, validate it and support your team after go-live.
The challenges this solves
Our validation is still on paper
Protocols, signatures and traceability live in documents and spreadsheets.
The tool does not fit our process
Out-of-the-box workflows do not match our SOPs or other tools.
The tool itself must be validated
Electronic records, audit trails and e-signatures must meet Part 11.
What we deliver
- Tool implementation from setup through validation
- Workflow configuration that integrates with your existing tools and processes
- Electronic records, audit trails and risk management configured for GxP
- Requirements-to-test traceability
- Validation of the ALM tool to 21 CFR Part 11
- Training and ongoing support after adoption
Systems and tools
- OpenText (Micro Focus) ALM
- Tricentis qTest
- Perforce ALM
- Jira
4 steps, clear deliverables
- 01
Assess
Review your validation process, tools and compliance goals.
You receive: Implementation scope
- 02
Configure
Tailor workflows to your SOPs and integrate existing tools.
You receive: Configured ALM workflows
- 03
Validate
Validate the configured tool for GxP use.
You receive: Validation package
- 04
Support
Train your team and provide ongoing support.
You receive: Training and support
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
Related services
Questions we hear most
Which ALM and test management tools do you work with?
OpenText (Micro Focus) ALM, Tricentis qTest, Perforce ALM and Jira.
Why move validation into an ALM tool?
It supports a paperless process with electronic records, audit trails and risk management in one place.
Does support end at go-live?
No. We provide training and ongoing support after adoption.
Take your validation paperless
Tell us about your tools and process, and we will scope the implementation.