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

Services

Computerized System Validation

ServicesComputerized SystemComputerized System Validation

As we all know, GMP-related computerized systems need to be validated to provide the documented evidence.Therefore, it helps to prove the application of the system which could effectively ensure the safety, quality and effectiveness of the drugs as well as the reliability and integrity of the data generated.

gempex experts have strong professional background and global project operation experience in computerized system validation. It can enable us to ensure the computerized system compliance and meet the intended use through system analysis and choosing appropriate validation strategies.

Service Advantage

A set of customizable validation documents package complying regulatory and client requirements (CN/EN/DE)

Professional guidance on CSV execution

Learning of knowledge and experience from CSV consultants

advantage

The Computerized System Common Service Contents

1. Validation of New project / New system

Validation of New project/system will be executed during the project phasereferring the GAMP methodology.Here we take the complex system for example, the following phases and documents can be covered:


①  Planning Phase

  • Define system objectives and assist in drafting or reviewing URS
  • Assist in drafting or reviewing quality project plan (if required)
  • Prepare the validation plan, including an initial risk assessment, according to the project schedule and validation requirements


②  Design Phase

  • Review design documents, such as DDS, HDS, SDS, etc.
  • Provide design qualification protocol, execution guidance and reports
  • Provide RA procedures and tools, organize detailed risk assessments based on requirements and design of complete reports.


③  Configuration, Installation and commissioning Phase

  • Assist in reviewing FAT protocol and report (if any)
  • Assist in reviewing SAT protocol and report (if any)


④  Validation Phase

  • Provide the IQ protocol, execution guidance and report
  • Provide the OQ protocol, execution guidance and report
  • Provide the PQ protocol, execution guidance and report


⑤  Report and release

  • Provide RTM document
  • Provide RA review report
  • Provide assessment report on Part 11 compliance  Provide validation summary report


2. Validation of old/existing system

Generally, we would suggest carrying out a gap analysis for the old system as the first step, which helps determining whether the system needs to be upgraded by considering the existing functions and management measures of the system.When we will provide the validation strategies considering the previous system using experience and performing the risk assessment and validation activities. gempex offers the following services:


  • Gap analysis and RA
  • CAPA and guidance
  • System experience report
  • Validation strategy establishment
  • Validation protocol, testing execution guidance and report

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