MTMeiTian Software
Data Protection & DR

MeiTian Pharma GMP Backup Management

Compliant with FDA 21 CFR Part 11 and NMPA GMP Annex 11; auto-generates IQ/OQ/PQ validation reports and e-signatures.

FDA 21 CFR Part 11NMPA GMP Annex 11IQ / OQ / PQ reportsE-signatureAudit trailDomestic + UOS
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MeiTian Pharma GMP Backup Management — 合规仪表板：IQ/OQ/PQ 验证与 Part 11 合规
Overview

What MeiTian Pharma GMP Backup Management does

MeiTian Pharma GMP Backup Management targets compliant backup for pharma and life sciences. It complies with FDA 21 CFR Part 11 and NMPA GMP Annex 11, supports database, VM and file-level backup/restore, and auto-generates IQ/OQ/PQ validation reports and e-signatures — making data integrity and compliance auditable.

Part 11
FDA compliant
Annex 11
NMPA GMP
IQ/OQ/PQ
Validation reports
E-signature
Built-in
Capabilities

Built for real-world scenarios

01

Regulatory compliance

Meets FDA 21 CFR Part 11 and NMPA GMP Annex 11 electronic-record and e-signature requirements.

02

Automated validation reports

Auto-generates IQ (installation) / OQ (operation) / PQ (performance) reports to speed up CSV.

03

Data integrity

Follows ALCOA+ principles; audit trail and tamper-proof records keep data trustworthy and traceable.

04

Multi-object backup

Database, VM and file-level backup/restore covering key pharma information systems.

Product UI

See it in action

MeiTian Pharma GMP Backup Management — 合规仪表板：IQ/OQ/PQ 验证与 Part 11 合规
合规仪表板：IQ/OQ/PQ 验证与 Part 11 合规
MeiTian Pharma GMP Backup Management — 审计追踪：防篡改哈希链与电子签名
审计追踪：防篡改哈希链与电子签名
Why choose it

Key advantages

E-signatureBuilt-in Part 11-compliant e-signature workflow.
Audit trailComplete, tamper-proof operation audit records.
Validation docs deliveredIQ/OQ/PQ reports generated in one click, saving validation hours.
Domestic-readySupports Kylin, UOS and loong64.
FAQ

About MeiTian Pharma GMP Backup Management

Which regulations does MeiTian GMP Backup comply with?

It complies with FDA 21 CFR Part 11 and NMPA GMP Annex 11 for electronic records and e-signatures, following ALCOA+ data-integrity principles.

Can it auto-generate validation reports?

Yes — it auto-generates IQ (installation), OQ (operation) and PQ (performance) reports, greatly reducing computer-system-validation effort.

Which backup targets and domestic platforms are supported?

Database, VM and file-level backup/restore, with Kylin, UOS and LoongArch (loong64) support.

Learn more about MeiTian Pharma GMP Backup Management

Explore more capabilities, or browse the full MeiTian product matrix.

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