Traceable sources
Follow citations to their passages. Distinguish regulations, guidance, internal procedures, and enforcement precedent.
CONTROLLED AI / A WORKFLOW YOU CAN EXAMINE
Know what shaped it.
Know who reviewed it.
Controlled AI means concrete checks around inputs, proposals, decisions, and records. It supports your team’s judgment throughout the work.
Explore in a tailored demo · See the sources, review steps, and records
CONTROLLED AI / MADE CONCRETE
Know the source.
Own the decision.
Control lives in the workflow: what the AI draws on, what your SMEs review, and what the record retains.
Human review and approvals
Accept, edit, or decline AI proposals. TMS routes deliverables through review and approval; RegLens supports review under your own procedures.
Audit trails and authorship
Follow revisions and review decisions. Use authorship reports to distinguish AI and human contributions, alongside the history of how the work developed.
ILLUSTRATION / SOP-118 §4.2 HISTORYIllustrative · fictional data
A deliverable has a history.
Make it visible.
-
AI PROPOSED · REVISION 1
Draft of §4.2 written from ACME-QM-001 and 21 CFR 211.192, with both cited.
-
HUMAN EDITED · M. WEBB
The author completes the site's approver role and rewords one step.
-
AI EDIT ACCEPTED · S. CHEN
The reviewer accepts a suggested change. Its original wording is kept.
The authorship report marks each section human, AI, or AI-edited, and lists who decided each AI edit and when.
CONSISTENCY / WITHOUT AUTOMATIC APPROVAL
Spend AI effort on a
repeatable process.
A defined standard gives an AI-assisted deliverable a structure and a basis. Review gives it an accountable decision. History gives your team a way to examine how it developed.
Before the run
Agree on references, workflow scope, document structure, and the version your team will use.
During review
Check source accuracy and applicability. Complete site facts. Accept, revise, or decline proposals.
After the decision
Follow revisions, authorship, and the decisions retained by the workflow. Verify export and retention needs during evaluation.
FROM A CONVERSATION TO A REVIEWED DELIVERABLE
Put the workflow
around the intelligence.
Use these criteria when evaluating any AI tool for regulated work. In a Qualisera demo, follow the sources, decisions, and records through the task.
| Your workflow needs | What to explore in Qualisera |
|---|---|
| A clear basis for each answer | Named regulatory sources and your SOPs, with citations that open supporting passages. |
| Documents governed by your standards | Selected governing documents and versioned agents, with a defined document structure. |
| Review decisions you can follow | Accept, edit, or decline proposals; inspect revisions, authorship, and retained decisions. |
| Validation approval and execution evidence | TMS requirements, test protocols, review, approvals, authenticated electronic signatures, and results. |
| A model arrangement that fits your organization | Anthropic or OpenAI for drafting/review; your own agreement, such as Azure OpenAI, configured per engagement. |
Features in a general-purpose AI product depend on its configuration. This is a set of evaluation criteria, rather than a claim that every chatbot lacks these controls.
Why visible human review matters: an FDA example from April 2026
In its April 2, 2026 letter to Purolea Cosmetics Lab, FDA addressed AI-created specifications, procedures, and production records. It required review for accuracy and CGMP compliance and described broader quality-system deficiencies. This is a concrete reason to make expert review visible.
Read the FDA source (opens in a new tab) ↗EVALUATE THE FIT / ASK THE SPECIFIC QUESTIONS
Clear scope.
Room for your judgment.
What can my team explore today?
The current product focus is RegLens and TMS. Explore regulatory research, document drafting and review, enforcement research, agents, and validation workflows in a tailored demo. Confirm the capabilities and setup available for your intended use during evaluation.
Does RegLens work with our controlled document system?
Yes. RegLens supports research, drafting, and review alongside the system your organization already uses for controlled documents, and approval follows your procedures. Authenticated electronic signatures are part of TMS.
What responsibilities remain with our organization?
Your qualified staff determine applicability, review and approve deliverables, and validate the software for its intended use. Qualisera supports those responsibilities with traceable sources, review decisions, and retained history.
What should we verify about data and access?
Explore organization isolation, access roles, retention, hosting, and vendor qualification. Choose Anthropic or OpenAI for drafting and review; using your own model agreement, such as Azure OpenAI, is scoped per engagement. Document the configuration and evidence your organization needs.
What is planned for clinical documents?
CRDM is in development: clinical document authoring and multi-role review.
SEE IT IN YOUR WORKFLOW
Show us the controls
your workflow needs.
Discuss review roles, source coverage, intended use, and the records your team needs to evaluate.