USE CASE / INSPECTION READINESS
How has FDA enforced
aseptic processing controls?
A QA department is asked to follow recent enforcement actions and keep the organization inspection ready. Ahead of an expected inspection, the head of quality wants to know what FDA has actually cited under 21 CFR 211.113(b), and to turn that record into a self-assessment of the site's own procedure.
Runs on RegLens Enforcements and Generate
THE SITUATION
A sterile manufacturing site expects an FDA inspection within the year. The head of quality knows what the regulation says. What they need is what FDA has objected to under it in recent inspections, and whether the site's own aseptic-processing procedure would hold up against the same objections.
“Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of all aseptic and sterilization processes.”
21 CFR 211.113(b)
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
See what is being cited now
Metrics shows what is cited, by whom and how often, across FDA warning letters and the EU non-compliance register, so the team can see which requirements recent actions keep returning to.
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YOUR SMEs
Filter the archive by the clause
Warning letters, Form 483 observations and inspection citations that cite 211.113(b), counted separately for each FDA center because each center's coverage starts at a different date.
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YOUR SMEs
Read findings beside the requirement
Each letter opens with its cited clauses, and where the archive holds the clause, the requirement is quoted beside the finding.
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AI ASSISTS
Ask what FDA keeps objecting to
Answers come from the letters themselves, each finding attributed to its firm, date and observation.
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AI ASSISTS
Draft a self-assessment against your own procedure
Take the recurring findings into RegLens Generate with your aseptic-processing SOP set as the governing document. It drafts a checklist in which each item cites the requirement it tests.
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YOUR SMEs
Your quality team decides what applies
Each AI-proposed edit is accepted or declined, and the checklist is completed by the people accountable for it.
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THE RECORD
Keep the trail
The checklist carries its revision history and exports to Word or PDF.
WHAT YOU HAVE AT THE END
Evidence you can show.
- A filtered set of letters and inspection citations, with counts per FDA center and the period each covers
- An answer on recurring findings, each attributed to a named letter
- A self-assessment checklist against your own procedure, citing the requirements, with its revision history
Qualisera supports your quality system. It does not replace your quality unit's review, approval or validation responsibilities.
Enforcement records show how a requirement has been applied. They are not binding regulation.
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