USE CASE / REGULATORY CHANGE
The regulation changed.
Which SOPs are out of date?
A quality department is asked to keep watch on regulatory change and assess its impact. When FDA's Quality Management System Regulation replaced the Quality System Regulation on February 2, 2026, the device quality lead had to find which procedures still describe the old rule and bring them up to date in a controlled way.
Runs on RegLens Ask, Review and Agents
THE SITUATION
21 CFR Part 820 now incorporates ISO 13485 by reference, and its section numbers changed with it. Procedures written to the old Quality System Regulation may cite sections that no longer exist, or miss what the new rule asks. Reading every procedure against the new text by hand takes weeks.
21 CFR Part 820, the Quality Management System Regulation, in force from February 2, 2026 in place of the Quality System Regulation.
HOW IT RUNS
Who does what.
Each step is marked by who acts: your SMEs, the AI, or the record that remains.
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YOUR SMEs
Ask what changed
Ask RegLens what the new Part 820 requires that the old rule did not. Both versions are in the corpus, so the answer can set them side by side.
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AI ASSISTS
Get an answer cited to the section
Each statement cites the section of the rule it rests on, and each citation opens the source beside the answer. Your own SOPs are searched alongside, so the same question finds the procedures that still cite the old sections.
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YOUR SMEs
Set the standard once
A review agent pins the new 21 CFR 820 and the checks the department wants closed on every procedure, such as design controls, CAPA, management review and records.
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YOUR SMEs
Review each procedure against it
Upload a procedure and run the agent from Review. Every check is closed: raised as a finding, recorded as passed, or reported as not assessable.
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AI ASSISTS
Get findings graded and cited
Findings are graded critical, major or minor, each citing the requirement behind it. Standards outside the corpus, such as ISO 13485, are cited from the model's knowledge and marked to verify.
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YOUR SMEs
Decide what changes
Your reviewer accepts or declines each proposed edit, and the revisions go through your own document control.
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THE RECORD
Know when the rule moves again
Published agents are checked against the corpus every day. When a regulation an agent pins changes, the agent is flagged for its owner, who decides whether to move it to the new version.
WHAT YOU HAVE AT THE END
Evidence you can show.
- A saved, cited answer on what the new rule changes, and which procedures still cite the old one
- A review report for each procedure, every check closed and every finding citing its requirement
- The same published standard applied to every procedure, its version recorded on each report
- A record of each AI edit accepted or declined, and a flag on the agent the next time a regulation it pins changes
Qualisera supports your quality system. It does not replace your quality unit's review, approval or validation responsibilities.
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