REGULATORY QMSR replaces 21 CFR Part 820 — is your quality system ready? Check your gaps free →
For Regulatory Bodies

Accelerate Assessments With Intelligent Pre-Screening

Reduce assessment backlogs without compromising rigor. AI-powered document pre-screening identifies gaps before your assessors begin — so they spend their time on judgment, not document trawling.

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The Assessment Bottleneck

Growing submission volumes, fixed assessor capacity

1
Submission Intake
Backlogs keep growing
Submission volumes grow faster than assessor headcount. Manufacturers wait months for initial review.
2
Pre-Screening
Inconsistent initial review
Different assessors flag different issues on identical documentation. Quality depends on who gets the submission.
3
Formal Assessment
Incomplete submissions waste cycles
Obvious gaps aren't caught until deep in formal review. Each round-trip adds weeks to the timeline.
4
Evidence Review
Verification is manual and tedious
Tracing claims back to source documents is the most time-consuming part. Hours spent cross-referencing page numbers.
What AI Pre-Screening Catches

Identified before an assessor touches it

Missing sections

Clauses with zero document coverage identified before formal review begins. No assessor time spent discovering what isn't there.

Unaddressed requirements

Specific clause requirements not evidenced in any submitted document. Flagged with exact clause references for targeted follow-up.

Evidence gaps

Claims without traceable source references. Every finding links to exact page, paragraph, and quote — or flags the absence.

Use Cases

How regulatory bodies use Aligntra

Lead Assessor
"I use AI pre-screening to flag incomplete submissions before formal assessment begins. Missing sections and unaddressed clauses get caught early — manufacturers can remediate before my time is invested."
Evidence Reviewer
"I trace manufacturer claims to exact pages and paragraphs in source documents. Every finding includes clickable evidence citations — verification in seconds instead of hours."
Training Manager
"New assessors learn gap identification against a consistent AI baseline. We compare what the AI flagged against what the assessor found, and use the differences to calibrate skills across the team."
Platform Features

Built for assessment rigor

Evidence traceability

Every finding links to the exact page, paragraph, and quote in source documents. Assessors can verify each claim with a single click through to the highlighted source text.

Standards-mapped findings

Gaps organized by clause for systematic assessment workflows. Findings map directly to the standard's clause structure.

Consistent baseline

AI applies the same criteria across every submission, reducing assessor variability. Human expertise is focused on the nuanced judgments that require it.

Augment, don't replace

A pre-screening tool that supports assessor judgment, not a substitute for it. Systematic document analysis so assessors focus on interpretive work.

Ready to reduce your assessment backlog?

Contact us for a confidential demo tailored to regulatory assessment workflows.

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