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  1. FORUM NEWS Last Post

    1. NEWS & ANNOUNCEMENTS

      (2 Viewing)

      Consult this forum for the latest news concerning the askaboutValidation community.

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      • Threads: 25
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    2. POLLS

      Just submit any ideas you have about poll ideas and we'll make them active in this section.

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      • Threads: 3
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  2. CSV/SOFTWARE VALIDATION/THE REGULATED CLOUD Last Post

    1. 21 CFR PART 11

      (1 Viewing)

      The Regulations and the Predicate Rules.

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      • Threads: 99
      • Posts: 408

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    2. 21 CFR PART 820 (The Regulations)

      Quality Systems Regulations - The Law.

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      • Threads: 39
      • Posts: 124

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    3. COMPLIANCE SOFTWARE

      What Software do you use In-House. What are the Pros and Cons

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      • Threads: 55
      • Posts: 228

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    4. SOFTWARE VALIDATION DOCUMENTATION

      Questions about CSV Documentation list them here.

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      • Threads: 116
      • Posts: 433

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    5. GOOD COMPUTER SYSTEM VALIDATION

      Best Practices - Worst Practices

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      • Threads: 148
      • Posts: 503

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    6. SCADA & PLC's

      Is it Software ? Is it Firmware - The Debate goes on!

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      • Threads: 36
      • Posts: 153

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    7. CLOUD COMPUTING - REGULATED ENVIRONMENT

      The Cloud is Coming - Are you ready to Go-Live?

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      • Threads: 4
      • Posts: 11

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    8. RISK ASSESSMENT

      How do you Evaluate Risk?

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      • Threads: 44
      • Posts: 186

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  3. SUPPLIER QUALIFICATION Last Post

    1. SUPPLIER QUALIFICATION

      Assessing your suppliers is one of the key aspects of good validation practice. Post all supplier questions here.

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      • Threads: 1
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  4. PROCESS VALIDATION Last Post

    1. HVAC VALIDATION

      Confused about HVAC's, post all your questions here.

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      • Threads: 21
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    2. GVP - GOOD VALIDATION PRACTICE

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      Good Validation Practice - For Process and Equipment Systems

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      • Threads: 382
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    3. PROCESS VALIDATION

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      Process Validation

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      • Threads: 84
      • Posts: 264

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    4. METHOD & ANALYTICAL VALIDATION

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      Method & Analytical Validation

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      • Threads: 222
      • Posts: 709

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    5. CLEANING VALIDATION

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      Cleaning Validation - what are your methods

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      • Threads: 445
      • Posts: 1,630

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    6. EQUIPMENT VALIDATION

      Equipment Validation - PLC's, SCADA's, Laboratory Equipment, Balances, pH Meters

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      • Threads: 201
      • Posts: 735

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  5. VALIDATION DOCUMENTATION Last Post

    1. MVP & VP’s (MASTER VALIDATION PLAN & VALIDATION PLANS)

      How do you create your MVP, who reviews it, who owns it?

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      • Threads: 12
      • Posts: 46

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    2. FAT & SAT (FACTORY ACCEPTANCE TESTS & SITE ACCEPTANCE TESTING)

      FAT’s and SAT’s what is the difference between both of them. What details do you put in yours?

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      • Threads: 7
      • Posts: 37

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    3. URS (USER REQUIRMENT SPECIFICATION)

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      This section has being created to discuss best practices for creating URS documents.

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      • Threads: 21
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    4. FDS (FUNCTIONAL DESIGN SPECIFICATION)

      Functional design specifications and how to create a successful one that meets all of the URS requirements.

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      • Threads: 3
      • Posts: 18

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    5. RTM (REQUIREMENT TRACEABILITY MATRIX)

      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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      • Threads: 2
      • Posts: 9

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    6. IQ (INSTALLATION QUALIFICATION)

      What type of checks do you include in your IQ

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      • Threads: 26
      • Posts: 86

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    7. OQ (OPERATIONAL QUALIFICATION)

      What type of checks do you include in your OQ

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      • Threads: 21
      • Posts: 71

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    8. PQ (PERFORMANCE QUALIFICATION)

      What type of checks do you include in your PQ

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      • Threads: 59
      • Posts: 202

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    9. DEVIATION & DISCREPANCY HANDLING

      How do you record your deviations and discrepancies and how do you close them out?

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      • Threads: 19
      • Posts: 105

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    10. VSR (VALIDATION SUMMARY REPORT)

      How detailed is your summary report, what details do you include in it?

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      • Threads: 4
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  6. BIOTECHNOLOGY & BIOPROCESSING Last Post

    1. BIOPHARMACEUTICAL FILL TO FINISH

      (Component preparation, Formulation, Sterile Filtration & Lyophilization)

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      • Threads: 4
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    2. BIOPROCESSING TECHNOLOGY & DESIGN ASPECTS

      (Process Trends, Disposables & Utility-Facility Design)

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      • Threads: 3
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    3. BIOANALYTICAL TECHNIQUES

      (HPLC,MALDI,Spectroscopy,Electrophoresis,Blotting)

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      • Threads: 2
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    4. REGULATORY TRENDS & QA

      (Regulatory Updates across globe and Quality assurance)

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      • Threads: 34
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    5. UPSTREAM & DOWNSTREAM PROCESSING

      (Handling lab,Pilot, Scale-up and Manufacturing operations)

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      • Threads: 3
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  7. GxP & RELATED TOPICS Last Post

    1. GAP - GOOD AUDITING PRACTICE - ISO 19011

      GAP - Good Auditing Practice Discussion Board

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      • Threads: 34
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    2. GCP - GOOD CLINICAL PRACTICES

      GCP - Good Clinical Practice Discussion Board

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      • Threads: 27
      • Posts: 30

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    3. GDP - GOOD DOCUMENTATION PRACTICE

      GDP - Good Documentation Practice & Documentation Discussion Board

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      • Threads: 55
      • Posts: 271

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    4. GEP - GOOD ENGINEERING PRACTICE

      (2 Viewing)

      GEP - Good Engineering Practice Discussion Board

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      • Threads: 68
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    5. GLP - GOOD LABORATORY PRACTICE

      GLP - Good Laboratory Practice Discussion Board

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      • Threads: 58
      • Posts: 197

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    6. GMP - GOOD MANUFACTURING PRACTICE

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      GMP - Good Manufacturing Practice Discussion Board

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      • Threads: 293
      • Posts: 930

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    7. QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000

      Quality Management Systems - ISO 9001:2000

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      • Threads: 44
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  8. INFRASTRUCTURE QUALIFICATION Last Post

    1. NETWORK QUALIFICATION

      A robust network is also a well designed network!

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      • Threads: 11
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    2. SERVER QUALIFICATION

      Servers are auditable components of a system, post a question to find out more!

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      • Threads: 7
      • Posts: 26

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  9. ASKABOUTVALIDATION BOOKS Last Post

    This forum is dedicated to the amazing E-Books, E-Learning Modules and Protocols developed by the Premier Validation and AskaboutValidation.com Team

    1. NEW RELEASES

      Get the scoop on AskAboutValidation's latest book releases!

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      • Threads: 7
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    2. FEEDBACK & REVIEWS

      Read an AskAboutValidation book lately? Let us know what you thought of it!

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      • Threads: 1
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    3. QUESTIONS ABOUT BOOKS

      Got a question about an AskAboutValidation book? Post it here, and you might just get an answer from the author!

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      • Threads: 2
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  10. USEFUL VALIDATION STUFF Last Post

    1. GENERAL VALIDATION DEFINITIONS

      (2 Viewing)

      Please add any useful validation definitions or acronyms that our community may find useful

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      • Threads: 75
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    2. VALIDATION TEMPLATES

      (1 Viewing)

      This section is available to post any useful templates that other members may find useful in their own projects

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      • Threads: 40
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    3. WHITE PAPERS

      This thread is specially designed for our members to upload white papers of interest.

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      • Threads: 76
      • Posts: 143

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    4. PRESENTATIONS

      If you have any presentations that you think would be useful to other members, please feel free to post them in this section

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      • Threads: 5
      • Posts: 16

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  11. COMMUNITY CENTER Last Post

    1. INTRODUCTIONS

      Welcome to the AskaboutValidation Community! Introduce yourself here so we can get to know you better.

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      • Threads: 4
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    2. INDUSTRY NEWS

      Discuss the latest technologies, takeovers and turn of events in the life science world.

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      • Threads: 79
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    3. GENERAL DISCUSSIONS

      (2 Viewing)

      Anything that doesn't fit in the main forum, please post it here.

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      • Threads: 323
      • Posts: 953

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    4. SIX SIGMA FORUM

      Six Sigma is a highly disciplined process that helps us focus on developing and delivering near perfect products and services

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      • Threads: 39
      • Posts: 125

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What's Going On?

Currently Active Users

There are currently 41 users online. 3 members and 38 guests

Most users ever online was 420, 04-24-2011 at 07:55 PM.

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