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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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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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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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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Chapter 1. The Kaye Validator
1.3 About this Manual
This manual is intended to provide overview information on the Validator, instructions on
getting started with the software, and step-by-step instructions on using the Validator in
standalone mode.
The first part of this manual provides an overview of the Validator hardware, instructions for
creating user accounts and entering asset and equipment information, and an overview on
using the Validator software. The second part of this manual covers using the Validator in
standalone mode, including calibrating sensors, running qualification studies, and verifying
sensor calibration.
The following is a brief description of each section of this user's guide:
Chapter 1 provides an overview of the Validator system.
Chapter 2 explains the Validator hardware and provides instructions for connecting the
system.
Chapter 3 provides instructions for creating user accounts.
Chapter 4 provides instructions for entering Kaye equipment into the system.
Chapter 5 provides instructions for entering customer assets into the system.
Chapter 6 provides instructions for creating setups.
Chapter 7 provides instructions for performing calibration or verification in standalone
mode.
Chapter 8 provides instructions for displaying live data on the Console.
Chapter 9 provides instructions for performing a qualification study in standalone mode.
Chapter 10 provides instructions for creating reports.
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Chapter 1. The Kaye Validator
1.4 The Kaye Validator System
The Kaye Validator system integrates hardware and software, and gives you the flexibility to
design and run studies in the way you find most productive. This section provides an
overview of the system and its use.
1.4.1 The Validator Hardware
The Validator is a self-contained instrument, incorporating high-accuracy sensor
measurement hardware with secure data recording capability. It accepts programming and
control from one or more Windows 8.1-based Consoles. The Validator provides standalone
functionality when calibrating sensors and running qualification studies.
Figure 2: The Validator Unit
The Validator accepts up to 48 inputs in any combination of thermocouple, voltage or
current inputs and 24 RTD inputs. The instrument is equipped with a universal power supply
(100-240 VAC) and connections for two Kaye temperature standards (although only one
standard can be used at any given time), one Kaye temperature reference, a USB cable and a
contact output for signaling a PLC or other device
The Validator includes a built-in USB flash drive interface for collecting data after the
completion of a study and a tablet PC for viewing data.
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Chapter 1. The Kaye Validator
1.4.2 Sensor Input Modules (SIMs)
The Validator uses Sensor Input Modules to provide secure connection of sensors to the
Validator while protecting the electronics from draft, dust, humidity, electrical noise and
mechanical shock. SIMs are designed to be wired once and used repeatedly. You can wire
SIMs yourself, or buy pre-wired SIMs to reduce preparation time. Once the SIMs are wired,
you can calibrate multiple harnesses at the same time and store them for later use.
Figure 3: Sensor Input Module
The Validator can be configured for up to 4 SIMs. Each SIM has:
•12 sensor input connections
•A memory chip to store calibration offsets, SIM serial number, slot location, and the serial
number of the Validator measurement board where calibration was performed
•A cold junction reference RTD to maintain measurement accuracy in different
environmental conditions
Using 4 SIMs, you can attach up to 48 inputs in any combination of thermocouples, voltage,
or current inputs. A dedicated 4-20 mA SIM is also available with 12 4-20 mA inputs and
one connection for an external power supply.
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Chapter 1. The Kaye Validator
1.4.3 Plug-In Hardware Connections
The Validator has connectors on the back of the unit for easy plug-in of SIMs, temperature
standards, temperature references, a USB cable, and a USB memory card on the left side of
the instrument. An icon indicating the type of device identifies each connector.
Figure 4: Validator Connections
For a more complete description of the hardware, see Chapter 2, The Validator Hardware.
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Chapter 1. The Kaye Validator
1.5 The Validator Software
The Validator software provides everything you need to perform validation testing. Using the
Validator software, you:
•Create user accounts and assign user IDs, passwords and permission levels.
•Create validation study setups that can be run standalone on the Validator or from a
Console. When calibrating sensors and running qualification studies from the Console,
the Validator software features expanded tools for graphing study data.
•Generate reports from secure data files that contain original calibration and
qualification data recorded during the study. Use the reporting utility to generate
reports containing only the results you need to document your study.
1.5.1 User Access
You can set user access to the Validator to match the way your company works. The
Validator software is designed user level has specific permissions that define system access.
Permissions can also be customized for each user.
1.5.2 User Identification
Each user is assigned two distinct levels of identification, user ID and password, which are
used to uniquely identify an authorized Validator user. Each user ID is associated with a
unique user name to provide traceability during the validation process.
The Validator requires users to enter their user ID and password whenever they:
•Create, modify, or move a setup
•Change the setup stored in the Validator
•Calibrate sensors or verify sensor calibration
•Manually start or stop a qualification study or exposure cycle
•Change preferences
Whenever an action occurs that requires a user ID and password, the user name associated
with that user ID and a time stamp are written to the file along with a description of the
action.
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Chapter 1. The Kaye Validator
1.5.3 Electronic Data Requirements
The Validator is designed to help you meet the guidelines for electronic signatures as
specified in FDA Regulation 21 CFR part 11, Electronic Records; Electronic Signatures.
•Two levels of identification - user ID and password
•Uniqueness of each user ID
•Users create their own passwords
•User ID and password required whenever an action affects the security or integrity of the
data
•Electronic signature identifies the user, and includes the date and time of the action
•If the data is tampered with, the entire data file becomes inaccessible
•Password expiration feature allows you to set a password expiration
•System Administrators can set a minimum-password length requirement
•Option to disable a user account if there are three consecutive login failures for the
user ID
•Secure audit trail files provide a complete listing of events that affect the integrity of the
Validator program and the Validator instrument. Audit trail files contain all events and
identify the type of action performed, the date and time the action occurred, the name of
the responsible operator, and any additional information required to understand the action
taken.
1.5.4 The Study Setup
The study setup defines everything required to calibrate sensors and run a qualification study.
When you create a setup, you:
•Define the sensors you are going to use in the study
•Assign sensors to groups and specify group calculations
•Define group events to be monitored during the qualification study
•Specify calibration setpoints, temperature stability, and deviation criteria for sensor
calibration
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Chapter 1. The Kaye Validator
•Specify start and stop conditions for the qualification cycle and the exposure cycle
•Specify how often to scan sensors
•Define the output relay
After you have created and saved your setup, you run the study by loading the setup into the
Validator via connection from your Console to the Validator. See the Validator online Help for
instructions on setting up a study.
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Chapter 1. The Kaye Validator
1.5.5 Sensor Calibration
The Validator provides both pre-qualification sensor calibration and post-qualification
calibration verification.
Before you perform a qualification study, you should calibrate the temperature sensors to
correct raw temperature readings to a traceable temperature standard. You can perform a one-
point calibration, a two-point calibration, or a two-point calibration and a one-point check.
Sensors that do not meet the pre-qualification calibration test criteria are marked as failed and
are not calibrated. Sensors that fail calibration cannot be used in a qualification study.
After the qualification study, you can perform a post-qualification verification to verify that
the sensor readings are still within the calibration criteria. You can perform a one-point,
two-point or three-point post-qualification verification. If a sensor fails post-qualification
verification, the sensor is noted as failed but the readings are still reported. Calibration
offsets are not changed during post-qualification verification.
You can calibrate temperature sensors in standalone mode or from the Console using the
Validator software. If your validation system includes a Kaye temperature reference and a
Kaye IRTD, you can perform fully automatic pre-qualification and post-qualification
calibrations. If you do not have a Kaye temperature reference you can manually set your
reference.
IMPORTANT: Standalone calibration requires a Kaye temperature reference and a Kaye
IRTD.
For instructions on sensor calibration, see Chapter 7, Calibrating and Verifying Sensors.
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Chapter 1. The Kaye Validator
1.5.6 The Qualification Study
During a qualification study, the Validator performs calculations and compiles data for your
reports. You can run the qualification study in standalone mode or from the Console using the
Validator software.
For instructions on running a standalone qualification study, see Chapter 9, The Qualification
Study. For Console-controlled qualification studies, see the Validator online Help.
1.5.6a Report Generation
The purpose of qualifying equipment is to document its performance, either to satisfy
regulatory requirements or to perform studies of your production processes. The Validator
software includes a comprehensive reporting utility that allows you to access original study
data to generate easy-to-read reports to document the specifics of your validation study. All
reports are generated from secure data files that can only be read by the Validator software.
You can create four different report types:
•Setup Report
•Calibration Report
•Qualification Report
•Calibration Verification Report
Each report is traceable to the original study data. You create reports each time from the
secure data files. If a secure data file is tampered with, it is no longer readable by the software
and you will not be able to generate reports.
For a more complete description of report generation, see the Validator online Help.
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Chapter 1. The Kaye Validator
1.6 Using the Validator System
The Validator system allows you the flexibility to design your qualification procedures to fit
your workplace requirements. To perform a typical qualification study, it is recommended to
follow the following steps in order:
1. Use the Validator software to create a setup.
A setup defines the type of sensors and the validation parameters specific to your production
process. If you have pre-wired SIMs, assign your sensor locations according to the SIM
configuration.
2. Print the Setup Report.
Use the Setup Report to verify your validation parameters and as a reference for connecting
your sensors.
3. If you do not have pre-wired sensors, wire your thermocouples and auxiliary sensors to
the SIMs as based on the Setup Report.
4. Connect the hardware and confirm connections.
Once the hardware is connected, use the Validator software to display a graphical
representation of your validation equipment to verify hardware and communications
connections.
5. Load the setup into the Validator to calibrate sensors and run your study standalone, or
you can calibrate sensors and run your study directly from your Console.
IMPORTANT: The Validator is designed to run either as a standalone instrument or
Console-controlled. When calibrating sensors and running
qualification studies, all major actions should be consistent. If the
Console is connected, you should control sensor calibration and your
qualification study from your Console. During sensor calibration and
the qualification study, you can use the Console to view data and track
your progress.
6. With your hardware configured for the validation study:
•Calibrate sensors against the temperature standard
•Run the qualification study
•Run post-qualification calibration verification
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