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SOFTWARE VALIDATION - SPONSORED BY PREMIER VALIDATION www.premiervalidation.com
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21 CFR PART 11
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The Regulations and the predicate rules.
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78 | 286 | |
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Quality Systems Regulations - The Law.
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29 | 85 | |
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Who has the best software - The pros and cons of what's out there. We want your honest opinions.
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45 | 192 | |
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SOFTWARE VALIDATION DOCUMENTATION
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URS/FDS/SDS - IQ/OQ/PQ - The correct document for the requirement at hand.
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98 | 365 | |
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Good Computer System Validation
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114 | 381 | |
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SCADA-PLC-Hardware Validation - Ladder Logic. classification, level of validation required.
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26 | 124 | |
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How to evaluate the risk involved with software validation.
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31 | 120 | |
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PROCESS VALIDATION
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GVP - GOOD VALIDATION PRACTICE
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Good Validation Practice - For Process and Equipment Systems
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304 | 1,020 | |
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METHOD & ANALYTICAL VALIDATION
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Method & Analytical Validation
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153 | 447 | |
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CLEANING VALIDATION
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Cleaning Validation - what are your methods
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307 | 1,132 | |
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Analytical Equipment Validation - Post here
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77 | 290 | |
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INFRASTRUCTURE QUALIFICATION - SPONSORED BY PREMIER INFRASTRUCTURE www.premierinfrastructure.com
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A robust network is also a well designed network!
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9 | 24 | |
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Servers are auditable components of a system, post a question to find out more!
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4 | 15 | |
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Workstations must be managed in a controlled fashion – they’re critical to the success of any business
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7 | 16 | |
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Servers can be sliced and diced and one physical machine can be multiple powerful virtual servers
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5 | 14 | |
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Fast network capabilities across sites provide for a massive amount of data, both disparate and consolidated.
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3 | 16 | |
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Picture a data centre full of all sorts of other large heavy things with flashing lights and fans blowing. Now qualify it. Where do you start?
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6 | 13 | |
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VALIDATION DOCUMENTATION
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How do you create your MVP, who reviews it, who owns it?
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8 | 30 | |
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FAT’s and SAT’s what is the difference between both of them. What details do you put in yours?
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3 | 22 | |
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This section has being created to discuss best practices for creating URS documents.
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10 | 42 | |
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Functional design specifications and how to create a successful one that meets all of the URS requirements.
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2 | 6 | |
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How do you set up your RTM documents, how long does it take you to create one from scratch? What do you trace in your RTM?
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2 | 4 | |
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What type of checks do you include in your IQ
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14 | 32 | |
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What type of checks do you include in your OQ
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11 | 22 | |
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What type of checks do you include in your PQ
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26 | 72 | |
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How do you record your deviations and discrepancies and how do you close them out?
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10 | 33 | |
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How detailed is your summary report, what details do you include in it?
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2 | 7 | |
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GxP & RELATED TOPICS
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GMP - GOOD MANUFACTURING PRACTICE
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GMP - Good Manufacturing Practice Discussion Board
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141 | 509 | |
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GLP - Good Laboratory Practice Discussion Board
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39 | 135 | |
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GDP - GOOD DOCUMENTATION PRACTICE
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GDP - Good Documentation Practice & Documentation Discussion Board
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42 | 199 | |
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Quality Management Systems - ISO 9001:2000
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33 | 103 | |
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GEP - GOOD ENGINEERING PRACTICE
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GEP - Good Engineering Practice Discussion Board
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50 | 169 | |
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GAP - Good Auditing Practice Discussion Board
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25 | 81 | |
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E-LEARNING | E-BOOKS & E-LEARNING MODULES
This forum is dedicated to the amazing E-Books, E-Learning Modules and Protocols developed by the Premier Validation and AskaboutValidation.com Team
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We are very proud to announce the release of out first e-book "An Easy to Understand Guide to Good Documentation Practices (GDP)"
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An Easy Understand Guide to Software Validation is a must read for anyone working in a regulated environment who works with computer systems on a regular basis
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1 | 1 | |
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DEFINITION & WHITE PAPER ZONE
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GENERAL VALIDATION DEFINITIONS
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Please add any useful validation definitions or acronyms that our community may find useful
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74 | 143 | |
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This thread is specially designed for our members to upload white papers of interest.
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52 | 103 | |
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GENERAL DISCUSSION FORUMS
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This forum is here for anything you want to discuss in general, about the site, general validation discussions, ways to improve the site, whats happeing in the indusrty right now.
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99 | 345 | |
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SIX SIGMA FORUM
(1 Viewing)
Six Sigma is a highly disciplined process that helps us focus on developing and delivering near perfect products and services
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32 | 98 | |
| What's Going On? | |
Currently Active Users: 16 (2 members and 14 guests)
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AskaboutValidation forum Statistics
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Threads: 1,973,
Posts: 6,697,
Members: 9,125,
Active Members: 489
Welcome to our newest member, KLEE
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