K-Patents PR-23 for K-Patents - Manual (Page 4)

Document/Revision No. IM-GB-PR23-ACP: Rev. 1.0 Effective: December 15, 2011
4
Appendix to the Instructions Manual PR-23
Section 6 Complying with Documentation and Validation Regulations ....................................... 31
6.1 Documentation ............................................................................................................. 31
6.2 Qualification ................................................................................................................. 31
6.3 Protocol Acceptance by Customer and List of Tests Performed ................................. 32
6.4 Electronic Data Management and Data Storage ......................................................... 32
6.5 Electronic Signatures/Audit Trail .................................................................................. 32
6.6 Record Keeping ........................................................................................................... 32
6.7 Security ........................................................................................................................ 32
6.8 System Validation ........................................................................................................ 33
6.9 K-Patents Refractometer System Adherence to Part 11 ............................................. 33
Section 7 Onsite Qualification Protocols and Records: Installation Qualification ..................... 35
7.1 Authorization and responsibilities ................................................................................ 35
7.1.1 Documents and procedures ............................................................................ 35
7.1.2 Authorized officiator ......................................................................................... 36
7.1.3 Execution ......................................................................................................... 36
7.2 System ......................................................................................................................... 36
7.2.1 Qualifying the system ...................................................................................... 36
7.2.2 Manufacturers and suppliers ........................................................................... 37
7.3 IQ Protocol ................................................................................................................... 37
7.3.1 Scope of delivery ............................................................................................. 37
7.3.2 Damage ............................................................................................................ 38
7.4 Documentation ............................................................................................................. 38
7.5 Operating environment ................................................................................................ 39
7.6 Installation .................................................................................................................... 39
7.7 Setting up the system components and devices ......................................................... 40
7.8 Electrical connections and wiring ................................................................................ 41
7.9 Ethernet connection ..................................................................................................... 42
7.10 Initial check and switching the device on ................................................................... 42
7.11 Installation Qualification Summary Report .................................................................. 43
Section 8 Onsite Qualification Protocols and Records: Operational Qualification .................... 45
8.1 Individual module and system components check ...................................................... 45
8.2 Installation Qualification has been performed successfully ........................................ 45
8.3 Test procedure ............................................................................................................. 46
8.4 Authorized officiator ..................................................................................................... 46
8.5 System qualification ..................................................................................................... 47
8.6 Setting up the system components and devices ......................................................... 47
8.7 Instrument verification with Sample holder and Refractive Index Liquids ................... 48
8.8 Instrument verification with Laboratory Test Cuvette for Static sampling and
Refractive Index Liquids............................................................................................... 49
8.9 Operational Qualification Summary Report ................................................................ 50