Function · Quality & Manufacturing
Investigations written from the records they cite.
SyncIQ writes your quality documentation from your own batch records, test results and complaints — and links every statement back to the record it came from.
Investigations, the annual review and the SOP set run on different clocks, so each one gets its own application.
The work
Three kinds of work, three different clocks.
01
Events that don't wait
Deviations, out-of-spec results and complaints turn up unannounced. The batch record is on paper, the test result is in LIMS, and the operator's account is in someone's inbox.
About 29 days to close a minor deviation. 50–60 for a major.
02
A review every twelve months
The annual product quality review answers to three regulators who each ask for it differently. Most teams build it from exports that were stale before they were pulled.
21 CFR 211.180(e) · EU GMP Ch. 1 · Schedule M
03
Documents that change with the process
Change one process and it runs through the SOPs that describe it, the forms that record it, the protocols that qualified it and the training behind them.
FDA expects proof each person trained on the version in force at the time.
Capabilities
What SyncIQ does.
Investigations written from your records
SyncIQ reads the batch record, the test results and the interview notes together — scanned and handwritten included — and writes the investigation from them. Every statement links to the record and page it came from.
Root cause, with the reasoning behind it
What was considered, what was ruled out and why — written down while the event is fresh. When an inspector asks eighteen months later, the answer is in the file.
Repeat events, found early
Past deviations on the same product, line or failure mode show up with the draft. Repeats are flagged, and the batches and products in scope are listed.
CAPAs with effectiveness checks
Actions, owners and effectiveness criteria written alongside the investigation, then tracked to closure. The check is defined while the reasoning is still on the page.
Annual reviews built from live data
Batch, deviation, complaint and stability data read as the review is written, not pulled from a quarterly export. It says what changed and what that means, with the data linked.
Every document a change touches
Change one process and SyncIQ finds the SOPs, forms, validation documents and training records that reference it, and drafts the impact assessment for each.
Protocols that match the SOPs they test
Validation protocols and reports written from the qualification record, matched to the procedures they test and the change control that triggered them — because they're written together, not one at a time.
Evidence
What FDA cited most often in FY2025.
In FY2025, the three provisions FDA cited most often across 21 CFR Part 211 were all about documents: procedures that weren't written down, investigations that weren't thorough, and procedures that didn't exist.
The findings behind them repeat: root causes with no data to support them, investigations that never widened to the other batches affected, and corrective actions nobody checked.
- #2
- most-cited provision in all of 21 CFR Part 211: failure to thoroughly investigate discrepanciesFDA drug inspection observations, FY2025
- 24%
- of deviations are repeats of an event already investigatedBioPhorum Operations Group
- 60–70%
- of deviations turn out to have no effect on product quality or patient safetyBioPhorum Operations Group
We already read batch records, CoAs and analytical reports to write Module 3, handwritten ones included. Pointing that at an investigation is a blueprint problem.
The applications
Three applications, one record layer.
A deviation runs on a thirty-day clock, the annual review on a twelve-month one, and the SOP set changes when the process does. Three separate jobs, so three applications, reading and writing the same records.
Unscheduled events
Investigation Desk
Deviations, OOS, root cause and CAPAs
The batch record is in one system, the test results in another, the interview notes in somebody's inbox. Investigation Desk reads all three and writes the investigation from them, with the reasoning recorded while it's still fresh.
See Investigation Desk
The twelve-month cycle
APQR Engine
Annual product quality reviews, built continuously
The annual review usually gets written from an export that was stale before it was pulled. APQR Engine builds it from current batch, deviation and stability data, and says what changed instead of restating the table.
See APQR Engine
The standing document set
SOP Studio
SOPs, change control and validation documentation
One process change runs through forty documents, and somebody has to find all forty. SOP Studio finds them, revises the set, and drafts the impact assessment for each one.
See SOP Studio
The three read and write the same records, on one audit trail and one security model. So the batch record that explained a deviation in March is the record the annual review cites in December, and the SOP revision that followed the CAPA points back to both.
Accountability
Reviewed and approved by your quality unit.
In April 2026 FDA issued its first warning letter citing the inappropriate use of AI under CGMP. A manufacturer had put AI-generated specifications, procedures and production records into use without review, and was cited under 21 CFR 211.22(c). The agency's expectation is that AI output is reviewed and approved by an authorised member of the quality unit.
SyncIQ works that way by design. Every statement in a draft links to the record it came from, and a person still signs it off.
21 CFR Part 11-aware. Your cloud, your data residency, full audit trail, and your data never trains foundation models.
Security & deploymentCoverage
What's covered, and the standards behind it.
Deviation and OOS investigations, root cause and CAPA, change control, validation documentation, complaints and recalls, supplier qualification, and the annual product quality review. Written against 21 CFR Part 211, EU GMP Part I and its annexes, revised Schedule M, and ICH Q7 for APIs — each document to whichever one applies to you.
What lands on your desk
- Deviation and OOS investigations written from the batch record and the test results
- CAPAs with the reasoning recorded at the time, not reconstructed later
- Change control packages
- Annual product quality reviews under 21 CFR 211.180(e), EU GMP Chapter 1 and Schedule M
- Validation protocols and reports
- Complaint and recall investigations
- Supplier qualification files
- Inspection responses where every statement traces to its record
Three bases, one review
21 CFR 211.180(e) asks for an annual review of each product's records; EU GMP Chapter 1 §1.10 specifies what the review must contain; revised Schedule M brought product quality review into Indian GMP, with MSME compliance extended to December 2025. And the scopes differ — FDA's review covers all batches produced, the EU's covers batches released, returned and rejected.
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