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AskaboutValidation forum

Welcome to the AskaboutValidation forum.

  1. GENERAL VALIDATION Threads / Posts  Last Post

    1. Use this thread to post any questions you have about calibration and metrology.

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      • Threads: 22
      • Posts: 62
    2. CLEANING VALIDATION

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      Cleaning Validation - what are your methods

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      • Threads: 600
      • Posts: 2,184
    3. Equipment Validation - PLC's, SCADA's, Laboratory Equipment, Balances, pH Meters

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      • Threads: 361
      • Posts: 1,259
    4. Good Validation Practice - For Process and Equipment Systems

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      • Threads: 424
      • Posts: 1,580
    5. Confused about HVAC's, post all your questions here.

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      • Threads: 68
      • Posts: 236
    6. Ask about validation of lab equipment and the methods used.

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      • Threads: 334
      • Posts: 1,147
    7. PROCESS VALIDATION

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      Process Validation

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      • Threads: 171
      • Posts: 487
    8. Applicable Regulations, Standards, and Guidelines, Planning, Design Basics

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      • Threads: 24
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    9. How do you Evaluate Risk?

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      • Threads: 55
      • Posts: 208
    10. Assessing your suppliers is one of the key aspects of good validation practice. Post all supplier questions here.

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      • Threads: 7
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    11. 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: 44
      • Posts: 136
    12. Anything that doesn't fit in the main forum, please post it here.

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      • Threads: 367
      • Posts: 1,055
    13. Discuss the latest technologies, takeovers and turn of events in the life science world.

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      • Threads: 269
      • Posts: 279
    14. (Regulatory Updates across globe and Quality assurance)

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      • Threads: 168
      • Posts: 199
  2. CSV/SOFTWARE VALIDATION/THE REGULATED CLOUD Threads / Posts  Last Post

    1. The Regulations and the Predicate Rules.

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      • Threads: 125
      • Posts: 484
    2. Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

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      • Threads: 1
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    3. The Cloud is Coming - Are you ready to Go-Live?

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      • Threads: 5
      • Posts: 18
    4. What Software do you use In-House. What are the Pros and Cons

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      • Threads: 69
      • Posts: 247
    5. A Risk-Based Approach to Compliant GxP Computerized Systems

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      • Threads: 8
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    6. Best Practices - Worst Practices

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      • Threads: 185
      • Posts: 612
    7. NETWORK QUALIFICATION

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      A robust network is also a well designed network!

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      • Threads: 11
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    8. At the heart of SAP functionality are approximately 10,000 data tables....need to know about the validation aspect?

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      • Threads: 4
      • Posts: 45
    9. Servers are auditable components of a system, post a question to find out more!

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      • Threads: 7
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    10. Is it Software ? Is it Firmware - The Debate goes on!

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      • Threads: 42
      • Posts: 165
    11. Questions about CSV Documentation list them here.

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      • Threads: 133
      • Posts: 490
  3. VALIDATION DOCUMENTATION Threads / Posts  Last Post

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

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      • Threads: 23
      • Posts: 70
    2. 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: 9
      • Posts: 43
    3. This section has being created to discuss best practices for creating URS documents.

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      • Threads: 28
      • Posts: 87
    4. Functional design specifications and how to create a successful one that meets all of the URS requirements.

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      • Threads: 4
      • Posts: 19
    5. 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: 4
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    6. What type of checks do you include in your IQ

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      • Threads: 30
      • Posts: 96
    7. What type of checks do you include in your OQ

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      • Threads: 31
      • Posts: 98
    8. What type of checks do you include in your PQ

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      • Threads: 88
      • Posts: 321
    9. How do you record your deviations and discrepancies and how do you close them out?

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      • Threads: 24
      • Posts: 118
    10. How detailed is your summary report, what details do you include in it?

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      • Threads: 6
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  4. GxP & REGULATORY TOPICS Threads / Posts  Last Post

    1. Anything you need to ask about the FDA.

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      • Threads: 5
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    2. CFR - Code of Federal Regulations Title 21

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      • Threads: 348
      • Posts: 1,071
    3. GAP - Good Auditing Practice Discussion Board

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      • Threads: 34
      • Posts: 121
    4. GCP - Good Clinical Practice Discussion Board

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      • Threads: 28
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    5. GDP - Good Documentation Practice & Documentation Discussion Board

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      • Threads: 64
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    6. GEP - Good Engineering Practice Discussion Board

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      • Threads: 74
      • Posts: 259
    7. GLP - Good Laboratory Practice Discussion Board

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      • Threads: 65
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    8. Quality Management Systems - ISO 9001:2000

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      • Threads: 49
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    9. Quality Systems Regulations - The Law.

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      • Threads: 43
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  5. LEARNABOUTGMP.COM Threads / Posts  Last Post

    1. All questions answered!

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      • Threads: 15
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  6. USEFUL VALIDATION STUFF Threads / Posts  Last Post

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

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      • Threads: 79
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    2. This section is available to post any useful templates that other members may find useful in their own projects

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      • Threads: 65
      • Posts: 220
    3. This thread is specially designed for our members to upload white papers of interest.

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      • Threads: 79
      • Posts: 147
    4. 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: 9
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  7. FORUM NEWS Threads / Posts  Last Post

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

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      • Threads: 27
      • Posts: 54
    2. Consult this forum for the latest news concerning the askaboutValidation community.

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      • Threads: 52
      • Posts: 111

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