• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

Services

CS Compliance Audit

ServicesComputerized SystemCS Compliance Audit

Faced with increasingly complex system structure and stricter regulations from various countries (such as FDA 21 CFR Part 11, EU Annex 11, and relevant appendices of NMPA), companies often find it difficult to independently and systematically identify all problems in CS management, including key issues such as the discrepancy between strategy and execution, loss of control over configuration permissions, lack of audit trails, and inadequate management of the electronic data lifecycle.

gempex provides professional compliance audit services for computerized system, aiming to provide companies with objective, in-depth, and executable compliance assessments. Our audit team has both in-depth knowledge of authority regulations and profound experience in technical implementation. Our team is able to identify potential compliance gaps from various perspectives, including system management, process implementation, and data integrity. From beginning, we have helped leading global pharmaceutical companies, local innovative companies, and supply chain partners effectively identify and control CS compliance risks, improve system reliability and audit responsiveness, and provide support for the establishment of a digital quality system.

Service Advantage

CS+GMP expert team
The team consists of experts with both computerized system knowledge and GMP regulatory background, who can deeply understand the system structure and collaborate efficiently with the technical team of the customer to provide companies with practical compliance solutions.

Audit experience in various industries and with various systems
Our service network covers various industries such as pharmaceuticals, medical devices, and cosmetics. We have audit experience in various complex systems such as ERP, MES, LIMS, and CDS, enabling us to support companies in smoothly dealing with audits conducted by domestic and foreign regulatory authorities and customers.

Cross-border audits
Leveraging our international team and project experience, we are able to provide multinational companies with cross-regional, cost-effective remote or on-site audit services, significantly reducing the cost and time involved in their multinational audits.

Tailored service
We take our customers’ requirements into account comprehensively and create customized audit plans to ensure that the audit content covers all key risk points and compliance requirements.

advantage

Service Scope

We provide comprehensive and multi-scenario CS compliance audit services, covering the following main types:


  • Comprehensive CS audit
    We conduct an in-depth audit of six core areas, including quality, laboratory, production, facilities and equipment, materials, and packaging labels, across four levels: guidelines, operating procedures, execution, and records, to objectively assess the level of compliance regarding CS management which results in a detailed audit report.


  • Special audit for specific reasons
    We provide special audits for specific reasons or changes (such as the addition of key systems like ERP, MES, and LIMS, or the occurrence of significant data deviation or warning letters), to assist companies to manage the compliance tasks.


  • Follow-up audit for improvement
    We re-examine the effectiveness of the corrective measures for audit findings to ensure that corrective and preventive actions (CAPA) are effectively implemented, systemic issues are fundamentally solved, and a fully compliant management system is established.


Service Workflow