Scyla reads batch records, certificates of analysis, SOPs, AI code, clinical protocols, any text, and returns specific regulatory violations with CFR references and remediation guidance. No AI. No LLM. No signup. Just rules that know what they're looking for.
Phrases like "rewrite so it matches," "scrapped the original," "use the black pen," "found a way to get it under." These are 483 Warning Letter territory and Scyla catches them directly.
[BLANK], [NONE], empty fields where attribution is required. Detects release-before-review, unsigned batch records, and missing QA approval — all ALCOA+ Attributable violations.
Parses calibration due dates and reference standard expiry across MM/DD/YYYY, MM/YYYY, and "Feb 2026" formats. Flags any equipment used past its calibration window.
Extracts numerical values and matches them against nearby spec ranges. Detects 31°C written alongside a 22-26°C specification and flags the OOS without deviation.
"Will fill in later," "I forgot to start the timer so I estimated," "will sign when I return from vacation." All flagged as non-contemporaneous recording.
"Customer needs this by Monday," "push it through," "justify it later if anyone asks." QA independence violations that undermine the entire release decision.
Post-It notes, sticky notes, paperclip attachments, margin scribbles. Any uncontrolled documentation attached to a regulated record is an immediate flag.
"I think it's fine," "looks clean enough," "probably okay," "seems fine." Records must be factual and objective. Subjective statements are MAJOR violations.
"There is no 'native' programming language that has FDA regulations built into its core syntax as primitive functions."Gemini 2.0 · April 2026
It exists now. You're using it.
Custom governance rules, jurisdiction templates, integration with your QMS, on-premise deployment, or a licensed Scyla compiler. Every engagement is scoped to your regulatory context.
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