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 |