Validation service

Ideal sets up a specialized validation service team, which is in charge of validation work of pharmaceutical water equipment, preparation process system and clean pipe distribution system.

Validation life cycle starts from URS, going through design stage, construction stage, installation qualification, operational qualification, and confirm whether URS is complete by final performance qualification.

Validation is used to create written evidence, ensuring to meet quality features predetermined by clients. Validation life cycle V-model diagram is as follows:

Validation test items:

Design Qualification: Operational qualification OQ  Automatic control system qualification IQ&OQ 
1)Supplier qualification  1)Personnel verification  1)Personnel verification
2)Personnel verification 2)IQ completion status verification IQ 2)Verification of test instrumentation calibration 
3)Design documents/drawings verification  3)SOP verification 3)System documentation verification
4)Main equipment/components/key instrumentation verification  4)Verification of test instrumentation calibration  4)Hardware installation verification 
5)Construction procedures verification  5)I/Otest   5)Software installation verification 
6)System function verification  6)HMI interface verification   6)Power verification
Installation qualification: 7)Alarm and interlock verification  7)I/O verification
1)Personnel verification  8)Password verification  8)Process parameters design verification 
2)DQ completion status verification 9)Data security verification  9)Failure confirm and power recovery verification 
3)System documentation verification  10)Running test verification 
4)Verification of test instrumentation calibration  11)Leak test verification 
5)Manual and parameter verification  12)Operation parameters verification 
6)Certificates verification  13)Water quality verification 
7)P&ID process and instrumentation diagram verification P&ID 14)Circulation capability verification 
8)Components verification  15)CIP verification  
9)Welding verification  16)SIP verification  
10)Slope verification  17)Cleaning verification 
11)Dead ends verification  18)Stirring verification 
12)Low emissions verification  19)Weighing verification
13)Electrical components verification 
14)Circuit diagram verification 
15)Installation environment and utilities verification