Kaye Validator AVS User manual

Validation
Kaye Validator ® AVS
User’s Manual
Kaye Validator User’s Manual

Kaye Validator ® AVS
Thermal Process Validation System
User’s Manual
M5100-EN Rev. A
May 2015

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Kaye Validator User’s Manual

Contents
Chapter 1. The Kaye Validator
1.1 Introduction....................................................................................................................1
1.2 Validator Benefits..........................................................................................................3
1.3 About this Manual .........................................................................................................4
1.4 The Kaye Validator System...........................................................................................5
1.4.1 The Validator Hardware .....................................................................................5
1.4.2 Sensor Input Modules (SIMs).............................................................................6
1.4.3 Plug-In Hardware Connections...........................................................................7
1.5 The Validator Software..................................................................................................8
1.5.1 User Access ........................................................................................................8
1.5.2 User Identification ..............................................................................................9
1.5.3 Electronic Data Requirements..........................................................................10
1.5.4 The Study Setup................................................................................................11
1.5.5 Sensor Calibration.............................................................................................12
1.5.6 The Qualification Study....................................................................................13
1.6 Using the Validator System..........................................................................................14
Chapter 2. The Validator Hardware
2.1 Introduction..................................................................................................................17
2.2 The Validator Instrument.............................................................................................18
2.2.1 Connection Ports...............................................................................................18
2.2.2 Symbol Identification .......................................................................................19
2.2.3 Side Port for Data Transfer...............................................................................20
2.2.4 The Console......................................................................................................21
2.2.5 Internal Memory...............................................................................................22
2.2.6 Backup Battery .................................................................................................24
2.3 Sensor Input Modules ..................................................................................................26
2.3.1 Wiring SIMs .....................................................................................................27
2.4 Kaye IRTD...................................................................................................................32
2.5 Temperature Reference................................................................................................33
2.5.1 Sensor and IRTD Installation ...........................................................................34
2.6 Connecting the System.................................................................................................36
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Contents
2.7 Setting the Validator Time and Date...........................................................................37
2.8 Preventive Maintenance ..............................................................................................37
2.8.1 Fuse Replacement ............................................................................................37
2.8.2 Calibration........................................................................................................37
2.9 Transporting and Shipping..........................................................................................38
Chapter 3. Creating User Accounts
3.1 Introduction.................................................................................................................39
3.2 Logging in as a Default System Administrator...........................................................40
3.2.1 Creating Your System Administrator Account ................................................41
3.3 Creating User Accounts............................................................................................... 44
3.4 Setting Preferences...................................................................................................... 46
3.5 Setting Policies............................................................................................................48
3.6 Setting Policies (cont.) ................................................................................................49
3.7 Online Help ................................................................................................................. 50
Chapter 4. Defining Equipment
4.1 Adding New Equipment..............................................................................................52
4.2 Checking Details for Existing Equipment................................................................... 53
Chapter 5. Defining Assets
5.1 The Asset Details Screen.............................................................................................57
5.2 The New Asset Screen ................................................................................................60
Chapter 6. Defining Study Setups
6.1 Create a Setup File ......................................................................................................64
6.2 Apply an Existing Setup..............................................................................................65
6.3 The Define Setup Screen.............................................................................................65
6.4 The Sensors Configuration Screen..............................................................................67
6.5 Understanding Groups.................................................................................................70
6.6 Assigning Sensors to Groups ......................................................................................71
6.7 Specifying Group Calculations....................................................................................73
6.8 Specifying Calibration Parameters..............................................................................74
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Contents
6.9 Specifying Qualification Study Conditions .................................................................76
6.10 Reviewing and Changing the Setup.............................................................................77
Chapter 7. Calibrating and Verifying Sensors
7.1 Introduction..................................................................................................................79
7.2 Loading a Setup into the Validator ..............................................................................80
7.3 Selecting Sensors .........................................................................................................82
7.4 Calibrating or Verifying Sensors..................................................................................83
7.4.1 Automatic, Semi-Automatic or Manual Mode .................................................84
7.4.2 Calculate Stability.............................................................................................85
7.4.3 Calculate Deviation of Uncalibrated Sensors...................................................85
7.4.4 Calculate Deviation of Calibrated Sensors.......................................................85
7.4.5 Data Logging Complete at Setpoint..................................................................86
7.4.6 The Graph View................................................................................................86
7.5 Current Calibration and Hardware Connections..........................................................87
7.5.1 Reasons for Calibration Failure........................................................................88
7.5.2 Completing Calibration.....................................................................................88
Chapter 8. Viewing Live Data
8.1 Select Validator............................................................................................................89
8.2 Monitoring Live Data...................................................................................................91
8.3 Check Communications Connections ..........................................................................97
8.4 Select a Temperature Standard.....................................................................................98
8.5 Changing the IRTD Address........................................................................................98
Chapter 9. The Qualification Study
9.1 Introduction..................................................................................................................99
9.2 Load a Setup...............................................................................................................101
9.2.1 Select a Setup File...........................................................................................101
9.3 Viewing the Active Qualification Study....................................................................104
9.4 Graph Real-Time Sensor Readings and Calculations ................................................106
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Contents
Chapter 10. Generating Reports
10.1 Reports Overview .....................................................................................................109
10.2 Report Types .............................................................................................................110
10.2.1 Setup Report...................................................................................................110
10.2.2 Calibration Report..........................................................................................111
10.2.3 Qualification Reports......................................................................................111
10.2.4 Calibration Verification Report......................................................................114
10.2.5 Audit Trail......................................................................................................114
10.3 The Reports Hub .......................................................................................................119
10.4 The Report Analysis Screen......................................................................................120
10.5 The Reports Details Screen.......................................................................................121
10.6 The Performance Analysis Screen.............................................................................125
10.7 The Summary Analysis Screen .................................................................................129
10.8 The Report Template Screen.....................................................................................131
10.9 The Creating Cycles Screen ......................................................................................135
10.10 The Add Cycles Screen.............................................................................................140
10.14 The Report Screen.....................................................................................................145
10.15 The Graph Report Screen..........................................................................................146
10.16 The Customize Calculations Screen..........................................................................149
10.17 The Customize Groups Screen..................................................................................150
10.18 Report Options Screen ..............................................................................................152
Chapter A. Understanding Audit Trail Events
Appendix B. Environmental Compliance
B.1 Waste Electrical and Electronic Equipment (WEEE) Directive................................151
B.2 Battery Disposal........................................................................................................152
B.2.1 What do the Markings Mean?........................................................................152
B.2.2 The Risks and Your Role in Reducing Them ................................................153
Appendix C. Safety and Precautions
Appendix D. Service information
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Chapter 1. The Kaye Validator
Chapter 1. The Kaye Validator
1.1 Introduction
Figure 1: The Kaye Validator
The Kaye Validator® system is a validation system designed for thermal process validation
in the pharmaceutical and biotechnology industries. It features automated sensor calibration
and qualification reporting.
A complete Kaye® validation package, which lets you perform a fully automated sensor
calibration, includes:
One or more Kaye Validator
One or more Windows 8.1-based Consoles for programming and control
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Chapter 1. The Kaye Validator
Up to four Kaye Sensor Input Modules (SIMs) per Validator (each SIM supplies up to
12 sensors)
A Kaye high temperature reference (HTR 400), a Kaye low temperature reference
(LTR –90, LTR –25/140 or LTR –40/140), or a Kaye cold temperature reference
(CTR –40 or CTR –80) for sensor calibration and verification
A Kaye Intelligent RTD probe (IRTD)
Premium grade thermocouples
Additional temperature and non-temperature sensors for qualification studies (optional)
Adobe® Acrobat®, to convert report files and audit trail files to a Portable Document
Format (PDF) file (optional)
Users can select, and log in to, any Console to communicate with any Validator, monitoring
current studies and calibrations. All Assets, Studies, and Qualification data are visible across all
Consoles. While a Console can log in to one Validator at a time, multiple Consoles can log in to
the same Validator. Users can disconnect a Console after initiating a study or qualification; also,
any user with any Console can stop a calibration or study currently running on any Validator.
Both Consoles and Validators can be on a user's local network, and users can obtain software
upgrades for the Consoles.
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Kaye Validator User’s Manual

Chapter 1. The Kaye Validator
1.2 Validator Benefits
The Kaye Validator brings important benefits to the validation process:
Designed to help meet FDA guidelines for protecting electronic data (21 CFR Part 11)
Fully validated software, hardware, and firmware
Measures and adjusts internal voltage continuously
Flexibility to operate as standalone or with a PC during testing
Built-in USB flash drive interface for loading setups, collecting data, and upgrading
firmware
Plug-in Sensor Input Modules minimize sensor handling and save calibration time
More flexibility to set up your test—assign sensors to groups to perform independent
calculations, perform distribution and penetration tests at the same time, or qualify
multiple chambers
Test results are stored in secure data files that can only be accessed through the Validator
software
Generate easy-to-read, spreadsheet formatted reports from a single, protected file: raw data
is never modified
Greater portability over other validation systems—weighs 20 pounds and includes a
carrying case
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