Regulations
Built in and cited to the exact section: FDA, ICH, EU GMP, MHRA, PMDA, Health Canada and NIST
CONTROLLED AI / LIFE SCIENCES / GxP COMPLIANCE
More intelligence.
Every decision
still yours.
Ask FDA, ICH, EU GMP and other regulations alongside your own SOPs, with every answer cited to the section. Draft GxP documents and validation evidence with human review, approvals, and a record of who wrote what.
QUALISERA / WORKSPACEProduct screenshot
RegLens and TMS from one workspace. CRDM is in development.
Your documents
Add your SOPs, specs and policies to a corpus private to your organization, searched alongside the regulations
Enforcements
Research on FDA and EU enforcement records — warning letters, Form 483s, EU GMP non-compliance reports
Audit trail
Every action recorded and every AI edit a human accept-or-decline decision, with an AI / human authorship report
SPECIALIST TOOLS / ONE CONTROLLED APPROACH
Built for the work.
Accountable to your team.
Regulatory work and validation have different needs. Start with the product that fits the task, with human judgment at the center of both.
Explore in a demo
REGULATORY INTELLIGENCE · ENFORCEMENT · DOCUMENTS
RegLens
Ask the regulations, see how they are enforced, and draft or review documents against them, with every statement cited to its section.
- Answers cited to the exact section of 21 CFR, ICH, EU GMP and more
- FDA warning letters and the EU non-compliance register
- SOPs, specifications and audit reports drafted, reviewed or cited with their regulatory basis
- Your department's document standards as versioned agents, run the same way every time
Explore in a demo
VALIDATION & TEST MANAGEMENT
TMS
Plan a validation, write its specifications and protocols, run the tests, and show the evidence, for any GxP system or process.
- A validation suite for each project and system, from expectations to summary report
- Specifications and protocols drafted with AI assistance, reviewed and approved by people
- Continuous traceability from requirement to test case to result
- Execution with e-signatures and deviations, and summary reports assembled from the records
REGLENS AGENTS / CONSISTENCY WITH CONTEXT
Make every
AI run count.
Make AI output more consistent, and spend fewer runs redoing AI-assisted drafts and reviews.
Set the references, document structure and house instructions for a document type once, and publish them as a version. Every draft and review runs on it, and audit trails and authorship reports show who decided what.
01 Define the standard02 Review the output03 Retain the history
Explore RegLens Agents
A shared standard makes review clearer across repeated work.
START WITH YOUR TEAM’S TASK / SAMPLE USE CASES
Recognizable work.
Clearer next steps.
REGLENS / ASK + REVIEW + AGENTS
Assess a regulatory change.
Find what changed, which procedures it touches, and review each one against the new rule.
Read the use case ↗REGLENS / ENFORCEMENTSStay inspection ready.
See what FDA and EU regulators have cited recently, and test your own procedures against it.
Read the use case ↗TMS / VALIDATIONValidate a vendor release.
Assess the release, test hardest where the risk is, and show the evidence.
Read the use case ↗REGLENS / CITEWrite defensible reports.
Audit, deviation and response reports with the requirement behind every observation, accepted line by line.
Read the use case ↗REGLENS AGENTS + TMSStandardize your documents.
Department agents for governance documents and project templates for validation, so every document starts from the same standard.
Read the use case ↗YOUR OWN TASKNot on the list?
Bring the document or workflow your team works on, and see where the tools fit.
Discuss your use case ↗CONFIGURED FOR YOUR ORGANIZATION
Your standards.
Your systems.
Your controls.
Choose how it is deployed: hosted for you, or in your own cloud by arrangement. Shape the tools around how your team works.
Discuss your setup ↗READY TO USE
- Department agents. References, sections, and house instructions, published as a version.
- Your document library. Your SOPs searched and cited beside the regulations.
- Model choice. Anthropic or OpenAI models, chosen per task.
- Roles and features. Who can do what, and the document types each TMS system uses.
SET UP WITH YOU
- Single sign-on. Access follows your identity provider.
- Your model agreement. Such as Azure OpenAI or Amazon Bedrock.
- System connections. Such as Veeva Vault, Jira or ServiceNow.
- Dedicated deployment. Hosted for you, or in your own cloud by arrangement.
- Onboarding and support. Setup, user onboarding, and responsive support, agreed with you for each engagement.
- Custom workflows. Domain agents and document structures beyond the standard tools.
Scoped, built, and validated per engagement.
BUILT FROM EXPERIENCE IN GxP
The work should
have better tools.
Qualisera brings experience in pharmaceutical and medical device quality systems to the design of practical software for regulated work.
Meet the people behind Qualisera ↗SEE IT IN YOUR WORKFLOW
Bring a real problem.
Explore the fit.
Walk through a regulatory or validation workflow. See where AI assists, how your team reviews, and what evidence remains.