Why this matters
In GMP-regulated environments, “where did that number come from?” is the most common inspector question. If a LIMS field “was transcribed from the PDF” but you can’t show which row, that data point is unauditable — and you fail both A (Attributable) and C (Complete) in ALCOA+.
ChromaParse is designed around one premise: every value must be machine-traceable back to its location in the source PDF.
How it works
Every parse result (JSON / Excel / LIMS payload) carries source metadata on every peak row:
{
"peak_id": 7,
"retention_time": 4.281,
"area": 1283491,
"_source": {
"pdf_sha256": "8f2a...c4",
"page": 3,
"bbox": [120.5, 412.3, 480.0, 425.8],
"row_index_in_table": 6,
"extracted_at": "2026-06-16T03:14:21Z",
"engine_version": "1.4.2",
"template_id": "waters-empower-3-assay",
"template_version": "2.1"
}
}Meaning: this area = 1283491 came from which PDF (pdf_sha256), which page (page), which location (bbox), with which engine version (engine_version) and which template version (template_version).
In the UI, clicking a value jumps to the source PDF and highlights the location. In LIMS, the audit-trail panel surfaces the same lookup.
Tamper-evidence
- PDF SHA256 is computed at upload and locked — any subsequent modification to the PDF triggers an audit alert
- Parse process is read-only — we never write back to or modify the source PDF
- Audit logs are stored independently — Local deployments write to dedicated audit tables; SaaS writes to write-once audit storage. Not deletable by ordinary users.
Alignment to ALCOA+
| ALCOA+ principle | How ChromaParse handles it |
|---|---|
| A Attributable | Every parse job records operator + timestamp |
| L Legible | Output is standard Excel/JSON — machine + human readable |
| C Contemporaneous | Parse timestamp = action timestamp, immutable |
| O Original | Source PDF is preserved; SHA256 locked |
| A Accurate | Numeric fields are 100% exact from the text layer; OCR pipeline tags precision explicitly |
| + Complete | Missing fields tagged review_needed, never silent |
| + Consistent | Same engine + template versions used across samples/dates |
| + Enduring | Parse index file can be archived alongside the original PDF |
| + Available | Standard export + LIMS direct integration |
Alignment to 21 CFR Part 11 / NMPA
- Electronic records: parse output + audit log + source PDF + index file = an auditable electronic record
- Electronic signatures: Enterprise supports two-factor e-signatures (optional)
- Closed vs open systems: Local deployment is a closed system (data never leaves the customer network); SaaS is an open system over an encrypted channel with audit retention
More: Compliance and certifications.
IQ / OQ / PQ validation pack
Every certified template ships with a corresponding IQ/OQ/PQ test pack; enterprise customers receive the full documentation under contract. See Enterprise / Delivery & operations.