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

Services

Data Integrity (DI)

ServicesComputerized SystemData Integrity (DI)

In recent years, with the widespread application of computerized systems, enterprises are facing dual challenges: on the one hand, regulatory agencies (such as FDA, EMA, NMPA) are increasingly strict in their review of electronic data, and a single data defect may lead to inspection failure, product slow sales, or even legal risks; on the other hand, due to insufficient technical knowledge and fragmented process management within the enterprise, data management often becomes "formalized," making it difficult to manage the data in a correct way and to meet dynamic compliance requirements.

With over 20 years of experience in the industry, gempex provides enterprises with comprehensive and practicable data integrity solutions. We not only precisely interpret domestic and international regulations related to data reliability (such as FDA 21 CFR Part 11, EU GMP Annex 11, and NMPA's "Data Management Standards"), but also possess the ability to integrate regulatory requirements into the actual operations of enterprises, assisting clients in building a compliant, efficient, and sustainable data governance system.



Service Advantage

CS+GMP expert team
The team comprises experts with both knowledge of computerized systems and GMP regulatory background, being able to deeply understand the compliance key points of data integrity in computerized systems and provide solutions that not only comply with regulations but also are technical feasibile.

Tailored solutions
We deeply understand your business needs and compliance goals, and provide highly customized service plans to ensure that every suggestion and measure aligns with the actual situation of the company and precisely addresses data management pain points.

Rich practical experience
We are familiar with the operational models and data management scenarios of various companies, accurately grasp the key compliance points of data integrity, and help enterprises efficiently identify risks, implement adjustments, and ensure continuous compliance with global regulatory requirements.

Full lifecycle coverage
From training to inspection, from document implementation to migration verification, we provide "one-stop" services for data integrity, significantly reducing the communication and management costs associated with multiple interfaces for companies.

advantage

Service Scope

We provide the following professional services around the entire data lifecycle:


1. Data integrity training

The trainings cover topics such as basic regulations, paper and electronic data management, data risk analysis, and inspection findings. This helps to improve the compliance awareness and practical skills among all employees.


2. Gap analysis

Through document review and system assessment, we comprehensively identify data risks in areas such as management procedures, operational processes, and computerized system controls within companies. We provide a detailed report on findings and a derived to-do-list and guide companies in implementing improvements.


3. Special audit

We conduct an in-depth analysis of six core areas, including quality, laboratory, production, facilities and equipment, materials, and packaging labels, across four levels: policy, operating procedures, execution, and records, to objectively assess the level of data management compliance.


4. Development of system documents for data integrity

We provide the following thematic document writing services, including:

  • Data integrity policy
  • Data lifecycle management
  • Data risk management
  • Electronic data management
  • System time accuracy management


5. Data risk assessment service

Based on business processes or specific computerized systems, we organize data flows and conduct risk assessments.


6. Data migration service

We provide one-stop support for GxP data and electronic data migration, including data analysis and classification, migration strategy development, risk assessment, verification of infrastructure or software, migration activity monitoring, data verification, and report writing.