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From your existing batch records and validation files.

Aligntra reads your batch records, master production records, validation protocols, deviation logs, CAPA records, and Quality Agreements — and tells you, requirement by requirement, where you stand against ICH Q7, ICH Q10, and 21 CFR 210/211. With the exact section cited. Your first audit in 30 minutes.

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ICH Q7 · ICH Q10 · 21 CFR 210/211 · 21 CFR Part 11 · EU GMP ENCRYPTED AT REST + IN TRANSIT NO TRAINING ON CUSTOMER DATA

finding #5247 · run 12.6s MAJOR NC

ICH Q7 · §5.4 · COMPUTERIZED SYSTEMS · DATA INTEGRITY

Audit-trail review missing for spreadsheet-based release calculations.

Your batch release uses Excel for assay calculations, but no documented review of the formula audit trail.

Source clause

"ICH Q7 §5.4 requires sufficient controls over computerized systems so that only authorized personnel can change records, with data input and processing output checked for accuracy — and changes to GMP-relevant data traceable."

AI reasoning

QC-SOP-014 Rev 03 documents the dilution-and-assay calculation flow using LIMS for raw data entry. Final release calculations are performed in QC-CALC-001.xlsx (Excel) — referenced in 14 batch release records from Q1 2026. The SOP does not require a documented review of the spreadsheet's formula audit trail per FDA Data Integrity guidance §III(C)(2). Three of those 14 batch records show formula edits with no second-person review log.

Related clauses: ICH Q10 §3.2.4 (change management) · ICH Q7 documentation controls — the same evidence, cited independently under each

EVERY CLAUSE, CITED

Industry PHARMA & BIOTECH

Standards live 2 / 5

Audit run time 30 MIN

Coverage 100% · NO SAMPLING

Status ● ACTIVE

If you've been through an FDA inspection or an EMA pre-approval visit, you already know the work.

RUN IN PROGRESS aud-26q1-ichq10 · 58% complete

23 / 40 docs · 19 min remaining

Live verdicts feed

§6.5 Validation of computerized systems QC-SOP-014 Rev 03 ● Major NC now

§7.4 Process performance / product quality monitoring QA-PV-002 Rev 04 ● Compliant 8s ago

§3.2.4 Change management system QA-CHG-001 Rev 05 ● Observation 21s ago

§9.4 Stability testing program QC-STAB-007 Rev 02 ● Compliant 35s ago

§6.7 Quality manual review QM-MASTER Rev 12 ● Compliant 49s ago

§8.1.4 Validation master plan VMP-2026 Rev 01 ● Observation 1m 6s ago

§4.4 Quality risk management QRM-PROC-001 Rev 03 ● Compliant 1m 24s ago

WHAT YOU GET BACK

Built for the way pharma QA actually works.

SOP X-RAY QC-SOP-014 Rev 03 · Computer System Validation · 32 pp

Page

Clause

Requirement

Status

p. 3

§6.1

Documentation system and specifications

p. 7

§6.2

Equipment cleaning and use record

p. 11

§6.3

Records of raw materials

p. 16

§6.4

Master production instructions

Partial

p. 21

§6.5

Batch production records

p. 25

§6.6

Laboratory control records

Partial

p. 29

§6.7

Batch production record review

Weeks → hours

Mock inspection prep that took two weeks runs in under an hour.

Drop your GMP documents — or connect Google Drive. Master batch records, validation protocols, SOPs, training records, deviation logs — all parsed page-by-page, indexed against the standard.

Data integrity native

ALCOA+ checks across electronic and hybrid records.

Audit trails, electronic signatures, and ALCOA+ attributes (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) read as evidence — including the spreadsheet-and-LIMS hybrid flows that auditors flag most often.

ICH Q7 + Q10 native

API GMP and pharmaceutical quality system, mapped as one.

ICH Q7 (API manufacturing) and ICH Q10 (PQS) overlap heavily. Aligntra reads them together so confirming a procedure under one counts everywhere it's reused.

Multi-region pass

FDA, EMA, MHRA, PMDA — confirm once.

ICH Q7 for API GMP, ICH Q10 for the pharmaceutical quality system — run the same document set against both, clause by clause.

STANDARDS · PHARMA & BIOTECH

Every framework a GMP manufacturer touches.

All requirements indexed from source text — the same document set runs against any standard you license.

ICH Q7

Good Manufacturing Practice for Active Pharmaceutical Ingredients

350

LIVE

ICH Q10

Pharmaceutical Quality System (PQS)

LIVE

21 CFR 210/211

FDA cGMP for finished pharmaceuticals

~280

21 CFR Part 11

Electronic records and electronic signatures

~50

EU GMP Annex 1

Manufacture of sterile medicinal products (2023)

~140

408 clauses indexed across the 2 live standards. 21 CFR 210/211, Part 11, and EU GMP Annex 1 coming Q3-Q4 2026.

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