Seven-module pharmaceutical quality suite from Akso, a Chongqing software vendor founded in 2020, built on a zero-code configuration layer the vendor classifies as GAMP 5 Category 4. Its regulatory compliance white paper is published without a form and carries a clause-by-clause 21 CFR Part 11 mapping. All documented deployments are in mainland China.
Akso eGxP (branded eGMP through 2025; both marks still appear on the vendor's site) is an integrated quality suite for pharmaceutical manufacturers, published by a Chongqing vendor founded in 2020. It comprises seven separately purchasable modules: QMS, covering deviation, change control, CAPA, OOS/OOT investigation, audit, supplier management, product release, and complaint and recall; DMS for the document lifecycle; TMS for role-based training; AMS for controlled-record archives; QRS for annual product quality review; ERS for configurable electronic records replacing paper GMP forms; and a module for marketing authorisation holders overseeing contract manufacturers.
The suite runs on Akso Gaia, a zero-code configuration layer the vendor markets as "ISPE GAMP5-Compliant Category 4" in English and 0代码纯四类可配置 in Chinese. Under GAMP 5, Category 4 covers configured products and carries a lighter validation burden than Category 5 custom code. The vendor publishes no rationale for the classification, and no supplier assessment or third-party audit accompanies it.
A regulatory compliance white paper on the vendor's site, accessible without a form, contains a clause-by-clause 21 CFR Part 11 mapping, five validation deliverables identified by document number, and a description of an audit trail the vendor states is exportable for FDA inspection. The QMS and other module pages do not reference the white paper and carry no clause-level compliance material.
The vendor states that the system is hosted on Alibaba Cloud. A 2026 CEPREI certificate covers full-stack operation on Hygon CPUs, Kylin OS and a Kingbase database, the configuration required under China's state-owned-enterprise IT substitution programme, which runs to the end of 2027. No hosting region or data-residency option outside mainland China is documented, and no deployment, office, reseller or partner outside mainland China was found. All named customers are mainland-China entities, including the two multinational subsidiaries among them, Eisai China and Sekisui Medical Technology (China).
Core Capabilities
FDA & GxP Compliance
International Standards
Security Certifications
Data Integrity & Validation
The vendor's white paper states that the system is hosted on Alibaba Cloud, with firewalling, distributed protection, intrusion prevention and web-application protection. No other cloud provider, region or residency option is documented in either language.
A 2026 product compatibility certificate from CEPREI, the MIIT-affiliated China Saibao laboratory, certifies full-stack operation on Hygon CPUs, Kylin OS and a Kingbase database. That combination is the one required under SASAC Document No. 79, which directs central state-owned enterprises to complete domestic IT substitution by the end of 2027.
Separate test, validation and production environments are described. On-premise and private deployment are referenced alongside cloud, but no first-party page sets out a deployment matrix, so none is recorded here rather than one inferred. Integration is by open standard REST APIs, with stated connectivity to ERP, LIMS, MES, CRM and PLM, including automated cross-system workflow triggers. Interfaces are available in Chinese and English.
The vendor asserts HTTPS end to end, data encryption, multi-factor authentication, long-term audit-log retention, a high-concurrency high-availability architecture, and backup and restore under a named internal procedure with periodic restoration testing. No attestation beyond company-level ISO/IEC 27001 accompanies these. Recovery time objective, recovery point objective, encryption specifications in transit or at rest, disaster-recovery site and strategy, and business-continuity activation are not published.
No pricing is published in any form: no list price, no band, no per-user figure, no indicative deal size and no pricing model. No Chinese- or English-language source supports even a range, so none is estimated here.
The licensing model is also undisclosed. Whether the suite is sold by subscription, by perpetual licence or per module is not stated anywhere, and the modular purchasing visible in the case studies indicates nothing about how each module is priced.
A free trial and a product demonstration are both offered. Both route to lead-capture form handlers rather than self-serve signup, and no page states whether the trial is self-serve or arranged through sales. Contact routes are direct: a Chongqing landline, a mobile number, an email address and a WeChat official account. No partner or reseller channel was found.
No implementation timeline is published: no typical duration, no phasing and no effort estimate for a manufacturer of any size. The vendor states a 100% project go-live rate and a high repurchase rate; both are self-reported and unaudited, and no methodology accompanies either.
Delivery is in-house. No implementation partner, systems integrator or reseller network was found, and two service lines are named, customer success management and training. The company reports 20-99 staff, and in mid-2026 content more than 200 customers across the seven modules. Its open implementation-consultant postings recruit management trainees from graduates within two years of leaving university, at ¥5,000-8,000 a month, for pharmaceutical quality digitalisation project delivery. The seniority and validation experience of the team assigned to a GMP deployment are not stated.
Two repurchases are published with the customer named: Boan Biotech extended from QMS to QDT in April 2026, and Sinopharm Taiji extended a 2024 subsidiary project into a group-wide agreement.
PharmaSpotter assessment from published vendor and third-party sources. No user reviews are on file for this product.
Strengths
No review platform lists this product, so nothing below is aggregated from users. Each item is drawn from a first-party page or an independent source. The vendor publishes a regulatory compliance white paper without a form, containing a clause-by-clause 21 CFR Part 11 mapping, five validation deliverables identified by document number, and an audit trail stated to be exportable for FDA inspection. The GAMP 5 Category 4 classification is stated by the vendor itself rather than inferred from the architecture. The chairperson has thirty years in pharmaceutical quality, including GSK and the CDMO Porton Pharma Solutions, and the co-founder came from a software career. Seven modules are documented, one of them covering marketing authorisation holder oversight of contract manufacturers. Customer evidence includes a signed testimonial from the named QA head of Eisai China describing a competitive selection process, two repurchases published with the customer named, and a go-live announcement published independently by Shandong Xinhua Pharmaceutical. ISO 9001 and ISO/IEC 27001 are both held at company level.
Limitations & Open Questions
Hosting is on Alibaba Cloud in mainland China, with no other region or residency option documented. The certified stack is Hygon CPU, Kylin OS and Kingbase, and no deployment, office, reseller or partner outside mainland China was found. All named customers are China entities, including the two multinational subsidiaries. No GDPR statement, privacy policy, data processing agreement or subprocessor list appears on either the Chinese or the English site. The clause-level Part 11 material appears only in the white paper, which the QMS page does not reference. EU Annex 11 and ALCOA+ are asserted on the ERS module page without an accompanying mapping. No pre-validated edition is offered. Whether the named IQ and OQ documents are supplied to every customer or priced separately, who performs PQ, and how upgrades are handled in a validated environment are not stated. There is no SOC 2 and no trust centre; company-level ISO/IEC 27001 is the only security attestation, and no certificate number is published. Recovery time objective, recovery point objective, encryption specifications, disaster-recovery strategy and business-continuity procedures are not published. No pricing, licensing model, implementation timeline, migration path or data-export documentation is published. The company reports 20-99 staff supporting more than 200 customers across seven modules, with delivery entirely in-house and no partner network. No third-party review or analyst coverage was found. The vendor's claim to a top-three position in China's pharmaceutical QMS market cites a 191-company digitalisation survey, which measures IT budgets, digitalisation goals and system selection rather than market share. Coverage that appears independent is largely vendor-authored: the CSDN blog is a vendor account, and the Sohu article is bylined AksoeGMP and carries an AI-content disclosure.
Help the community
Share your experience with Akso eGxP anonymously. Your insights help pharmaceutical professionals make better software decisions.
Contribute Anonymous FeedbackPublicly disclosed pharmaceutical and biotech organizations
Jump to section