Compliance

Aligned with the regulations your auditors quote

ChromaParse maps cleanly to ALCOA+ data integrity principles, FDA 21 CFR Part 11 audit trail expectations, EU GMP Annex 11, and NMPA pharmaceutical record requirements.

ALCOA+ alignment

Each ALCOA+ attribute and how ChromaParse meets it.

Code	Principle	How ChromaParse satisfies it
A	Attributable	Every action recorded with operator identity, timestamp, file hash, and source bbox.
L	Legible	Audit log uses plain text, structured fields, and standardized timestamps in UTC.
C	Contemporaneous	Audit events written synchronously at the time of action; no batch backfill.
O	Original	Source PDF preserved alongside extracted data with cryptographic linkage. Source-trace shows the byte-exact origin of every value.
A	Accurate	Per-cell confidence scoring. Low-confidence cells surfaced for review; reviewer actions are themselves audited.
+C	Complete	All extracted data, all rejections, all overrides recorded — including unsuccessful operations.
+C	Consistent	Single canonical data format across all export channels. Same PDF always produces the same extraction.
+E	Enduring	Audit log retained for the regulatory retention period (default 7 years for GMP, configurable).
+A	Available	Audit log queryable via UI and API; export to PDF for inspection on demand.

Regulatory mapping

Specific clauses and how ChromaParse satisfies them.

21 CFR Part 11

FDA Electronic Records and Signatures

ChromaParse provides closed-system audit trail (§ 11.10), unique user identification (§ 11.10(d)), authority checks (§ 11.10(g)), and time-stamped records (§ 11.10(e)). Electronic signatures available in Enterprise tier.

Official source

EU GMP Annex 11

Computerised Systems

Validation lifecycle support (§ 4), audit trail (§ 9), data integrity controls (§ 7-8), and incident management (§ 13). IQ/OQ/PQ pack provided with Enterprise tier.

Official source

NMPA «Drug Records and Data Management Requirements» (2024)

China NMPA pharmaceutical record requirements

Local deployment recommended for full compliance with data residency. Audit log compatible with NMPA inspection scope. We can provide compliance Q&A with your QA team.

Official source

ICH Q9 (R1)

Quality Risk Management

ChromaParse extraction is a validated process step in QC data integrity. Risk assessment templates available on request to support change control.

Validation support

Enterprise customers receive an IQ/OQ/PQ validation pack covering installation qualification, operational qualification (including test cases for each supported instrument), and performance qualification. Updates to the pack are included in annual maintenance.

Request validation pack

Installation Qualification (IQ) — environment checks, service health
Operational Qualification (OQ) — per-instrument extraction test cases
Performance Qualification (PQ) — production-equivalent end-to-end runs
Validation Master Plan template for inclusion in your Quality System