Compliance and certification

GMP + 21 CFR Part 11 dual-compliant electronic batch record system

Electronic batch records, audit trail, and electronic signature done together, so any vial an inspector picks can be traced back to its full evidence chain — covering NMPA, FDA, and EMA frameworks.

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Compliance frameworks we cover

GMP Annex (China NMPA)

In production

Aligned to electronic batch records, data integrity, and computerized system validation chapters; documents shipped with the product.

21 CFR Part 11 (US FDA)

In production

Electronic Records and Electronic Signatures both compliant; full audit trail with timestamps and SHA-256 signatures.

EU GMP Annex 11 (EMA)

In production

Aligned to computerized systems, risk management, and change control chapters; export-friendly.

Domestic stack and MLPS Level 3

In production

Kylin V10, Huawei Ascend, and domestic databases adapted end to end; MLPS Level 3 documentation shipped with the product.

Compliance document downloads

Full whitepapers and mapping tables are in final review.

GMP computerized system validation whitepaper

PDF · download opening shortly

21 CFR Part 11 mapping table

PDF · download opening shortly

Domestic-stack compatibility whitepaper

PDF · download opening shortly

MLPS Level 3 conformance statement

PDF · download opening shortly

Need an early look? Contact sales — we can share a redacted sample under NDA.

Want a redacted electronic batch record sample?

Contact sales; the full version is available after NDA.

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