Design consulting and verification services

V model and validation

The V model is a ladder model for software development and testing. It begins with the upper left corner of the branch: the first step is to develop a User Requirement Specification (URS) by the prospective user of the system. URS is commonly referred to as "user requirements" in German. The next step is the system designer to develop a "functional specification", also known as "functional design standards (Functional Specification, FS)", which describes how the user requirements into the system.

The technical specification (TS) describes in detail the process of incorporating user requirements into the system, and TS is the link between the system consultant and the software developer. Software developers on the basis of the system programming and configuration, after the initial test. After completing these steps, the trend of the V model is turned up: the test phase begins. The risk analysis identifies the content to be tested. In the range regulated by GMP, at least all important functions related to GMP should be tested. Functional testing is first performed by the system vendor. After this phase (including the risk of troubleshooting) after the end of the user acceptance test, the two tests are to check the various functional blocks. The next step is to check the integrity of the business case in the integration test, for example, which processes run through the production planning, ordering, arrival, shipping the whole process. In addition, the test range also includes permission testing and data migration testing. Only after completing all the tests (except for a few risk-free failures) and having other prerequisites (such as training for users) can the system be put into use. Delivery requires formal formalities.

Verification system

Endeavor"s GMP Consulting and Verification Team is composed of a group of professionals with a background in the pharmaceutical industry and experts from home and abroad. It has a deep understanding and rich practical experience in domestic and foreign GMP regulations and guidelines. Can provide you from the design audit, VMP preparation, DQ to follow-up IQ / OQ / PQ and other verification services, as well as the provision of pharmaceutical quality management system and file system consulting and guidance, gap analysis and simulation checks and other GMP consulting service.