leading supplier of cold chain solutions

 IQ/OQ Made Simple:
 Step by Step Instructions
 Comprehensive Software
 Overview
 Detailed Checkpoints
 Data Validation/Verification
 Free Technical Support
 Weeks of Time Savings
 FlashLink Data Manager
 

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 IQ/OQ Protocol for In-Transit FlashLink® Data Manager Software Helping
 Life Science Companies Achieve FDA 21 CFR Part 11 and cGMP Compliance

The In-Transit FlashLink series software and data loggers provide a significant cost savings to users who require convenient and cost effective “fail-safe” trip data collection and recording.

Customers with the new DeltaTRAK IQ/OQ (Installation Qualification / Operational Qualification) Protocol will appreciate the step-by-step guide to software validation and data management offered by the Data Manager Software because it eliminates the time consuming process of developing your own software validation protocol from scratch. With the DeltaTRAK IQ/OQ Protocol, the FlashLink Data Manager Software is assured with robust data categorization, validation and reporting in compliance with FDA 21 CFR Part 11 and cGMP (current Good Manufacturing Practice) requirements.

The In-Transit FlashLink Data Manager Software, with the IQ/OQ Protocol, greatly enhances the overall manageability and reporting capability of data gathered by the DeltaTRAK In-Transit FlashLink Data Loggers. This enables users to better meet data integrity and security requirements defined by FDA 21 CFR Part 11 and in support of their cGMP. Trip data and reports can now be compiled, analyzed, validated and presented in much simplified and guided ways not previously possible.

TABLE OF CONTENTS
DOCUMENT REVISION HISTORY
QUALIFICATION PROTOCOL SIGNOFF
INTRODUCTION
          Scope
          Electronic Data Logger Record Management Software
          Overview of FDA 21 CFR Part 11
          Effect of 21 CFR Part 11 on Electronic Data Logger Records
OBJECTIVES
PRODUCT DESCRIPTION
          Overview of Flashlink Data Manager
          Part11 Compliance Ready Checklist
QUALIFICATION TEAM AND RESPONSIBILITIES
MATERIALS AND EQUIPMENT
DOCUMENTATION
INSTALLATION QUALIFICATION
          Documentation Review (Attachment A)
          Standard Operating Procedures (Attachment B)
          Computer System Verification (Attachment C)
          Software Install (Attachment D)
          Software Verification (Attachment E)
OPERATIONAL QUALIFICATION
          Effective Download and Store of Logger Records (Attachment F)
          Authentication and Access Control (Attachment G)
          Electronic Signature & Manifestation (Attachment H)
          File Integrity Check (Attachment I)
          Audit Trail (Attachment J)
          Secure Backup (Attachment K)
          Exporting and Emailing Reports ((Attachment L)
          Functional Custom Messaging (Attachment M)
          Test Criteria (Attachment N)
ACCEPTANCE CRITERIA
ATTACHMENT A — DOCUMENTATION REVIEW
ATTACHMENT B — STANDARD OPERATING PROCEDURES
ATTACHMENT C — COMPUTER SYSTEM VERIFICATION
ATTACHMENT D — SOFTWARE INSTALL
ATTACHMENT E — SOFTWARE VERIFICATION
ATTACHMENT F — EFFECTIVE DOWNLOAD OF LOGGER RECORDS
ATTACHMENT G — AUTHENTICATION & ACCESS CONTROL
ATTACHMENT H — ELECTRONIC SIGNATURE & MANIFESTATION
ATTACHMENT I — FILE INTEGRITY CHECK
ATTACHMENT J — AUDIT TRAIL
ATTACHMENT K — SECURE BACKUP
ATTACHMENT L — EXPORT & EMAILING REPORTS
ATTACHMENT M — CUSTOM MESSAGING
ATTACHMENT N — TEST CRITERIA
ATTACHMENT O — SIGNATURE REFERENCE
ATTACHMENT P — TEST RESULTS SUMMARY SHEET