Function · Quality & Manufacturing

Deviation investigations written from the records they cite.

SyncIQ drafts your GMP documentation from your batch records, test results and complaints, and links every statement to its source record.

Investigations, the annual review and the SOP set each get their own application.

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The work

Three kinds of work, three different clocks.

  • 01

    Deviations and OOS results that don't wait

    Deviations, OOS results and complaints turn up unannounced. The batch record is on paper, the result in LIMS, the operator's account in an inbox.

    About 29 calendar days to close a minor deviation.

  • 02

    An annual product quality review every twelve months

    The APQR answers to three regulators, each asking for it differently. Built from exports, it can be out of date before it's finished.

    21 CFR 211.180(e) · EU GMP Ch. 1 · Schedule M

  • 03

    Change control that runs through every document

    One process change runs through the SOPs that describe it, the validation master plan and protocols that qualified it, and the training.

Capabilities

What SyncIQ does.

  • Deviation and OOS investigations from your records

    Drafted from batch records, test results and interview notes, handwritten included, each statement linked to its record and page.

  • Root cause analysis, with the reasoning behind it

    What was considered, what was ruled out and why, recorded while the event is fresh.

  • Recurring deviations, found early

    Repeats on the same product, line or failure mode are flagged, with the batches and products in scope.

  • CAPAs with effectiveness checks

    Actions, owners and effectiveness criteria drafted with the investigation, then tracked to closure.

  • APQRs built from live data

    Built from current batch, deviation, complaint and stability data. States what changed and what it means, data linked.

  • SOP management when the process changes

    SyncIQ finds the SOPs, forms, validation documents and training records a change touches, and drafts each impact assessment.

  • Validation protocols that match the SOPs they test

    IQ/OQ/PQ, process and cleaning validation protocols and reports, drafted from the qualification record and matched to the SOPs.

Evidence

The 483 observations FDA cited most in FY2025.

In FY2025, FDA's two most-cited 21 CFR Part 211 provisions were both about documents. The first was quality unit procedures not written down or followed, under 211.22(d).

The findings repeat: root causes with no supporting data, investigations never widened to other affected batches, and corrective actions that didn't stop recurrence.

#2
most-cited Part 211 provision: failure to thoroughly investigate (211.192)FDA drug inspection observations, FY2025
24%
of deviations are repeats of earlier eventsBioPhorum survey of 13 member companies, 2017

The applications

Three applications, one record layer.

The batch record behind March's deviation is the one December's APQR cites, and the CAPA's SOP revision points to both.

Accountability

Reviewed and approved by your quality unit.

In an April 2026 warning letter, FDA cited a drug manufacturer under 21 CFR 211.22(c) for putting AI-generated specifications, procedures and master production records into use without quality unit review.

SyncIQ drafts. Every statement links to its record, and your quality unit signs off.

Security & deployment

Coverage

What's covered, and the standards behind it.

Written against 21 CFR Part 211, EU GMP Part I and its annexes, ICH Q7 for APIs, ICH Q9(R1) and Q10, and revised Schedule M, to whichever applies to you.

What lands on your desk

  • Deviation and OOS investigations from batch records and test results
  • CAPAs with effectiveness checks, tracked to closure
  • Change control packages
  • Annual product quality reviews
  • Validation protocols and reports
  • Complaint investigations
  • Supplier qualification records
  • Inspection responses traced to their records
  • SOPs and revisions with change history

Something in quality you don't see here? Tell us what's slowing you down →

Start where it hurts.

We'll run it live on one of your own open investigations, from your own records.

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