CONTROLLED AI / LIFE SCIENCES / GxP COMPLIANCE
Research FDA, ICH, EU GMP and other regulatory sources alongside your SOPs. Develop quality documents and validation evidence with human review, approvals, and authorship history.
Life Sciences Compliance Platform
RegLens and TMS from one workspace. CRDM is in development.
View full-size screenshotSPECIALIST TOOLS / ONE CONTROLLED APPROACH
Regulatory work and validation have different needs. Start with the product that fits the task, with human judgment at the center of both.
REGULATORY & QUALITY DOCUMENTS
Find the regulatory basis. Develop a draft. Review it against named sources.
VALIDATION & TEST MANAGEMENT
Connect requirements, test protocols, execution, and the people responsible for approval.
REGLENS AGENTS / CONSISTENCY WITH CONTEXT
Put every AI run to work with a shared standard, a reviewer, and a record.
Use versioned references and document structures to support more consistent AI-assisted deliverables. Keep review decisions traceable, with audit trails and authorship reports that make contributions visible.
A shared standard makes review clearer across repeated work.
REGULATORY CONTEXT / YOUR DOCUMENTS / VISIBLE REVIEW
Bring the references and document controls your quality team works with into each AI-assisted workflow.
FDA · ICH · EU GMP · MHRA · PMDA (Japan) · Health Canada · NIST
Open the supporting source and section alongside an answer. Keep regulations, guidance, and internal documents identifiable.
Select governing SOPs, policies, and templates for a draft. Work with an organization-scoped library of documents alongside the regulatory sources.
Accept, edit, or decline proposals. Follow the author, revision, and review decision through audit history and authorship reports.
Draft and review with Anthropic or OpenAI. Using your own model agreement, such as Azure OpenAI, is scoped to your engagement.
START WITH YOUR TEAM’S TASK
One versioned structure. Site facts and conclusions reviewed by people.
Explore the workflow ↗TMS / VALIDATIONConnect changed requirements to reviewed tests and retained results.
Explore the workflow ↗REGLENS / ENFORCEMENTSRead published observations alongside the rule and your procedures.
Explore the workflow ↗BUILT FROM EXPERIENCE IN GxP
Qualisera brings experience in pharmaceutical and medical device quality systems to the design of practical software for regulated work.
Meet the people behind Qualisera ↗CUSTOM SOLUTIONS / SCOPED TO YOUR WORK
Discuss domain agents, document structures, and connections to your existing systems. Start with the task, the sources, and the controls your team needs.
SEE IT IN YOUR WORKFLOW
Walk through a regulatory or validation workflow. See where AI assists, how your team reviews, and what evidence remains.
