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AskaboutValidation forum

Welcome to the AskaboutValidation forum.

  1. FORUM NEWS Threads / Posts  Last Post

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

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      • Threads: 49
      • Posts: 106
    2. Welcome to the AskaboutValidation Community! Introduce yourself here so we can get to know you better.

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      • Threads: 26
      • Posts: 51
  2. 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: 19
      • Posts: 56
    2. CLEANING VALIDATION

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      Cleaning Validation - what are your methods

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      • Threads: 581
      • Posts: 2,130
    3. EQUIPMENT VALIDATION

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

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      • Threads: 332
      • Posts: 1,166
    4. Good Validation Practice - For Process and Equipment Systems

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      • Threads: 419
      • Posts: 1,568
    5. HVAC VALIDATION

      (3 Viewing)

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

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      • Threads: 58
      • Posts: 213
    6. Ask about validation of lab equipment and the methods used.

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      • Threads: 309
      • Posts: 1,089
    7. Process Validation

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      • Threads: 161
      • Posts: 460
    8. Applicable Regulations, Standards, and Guidelines, Planning, Design Basics

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      • Threads: 21
      • Posts: 45
  3. RISK ASSESSMENT Threads / Posts  Last Post

    1. RISK ASSESSMENT

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      How do you Evaluate Risk?

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      • Threads: 55
      • Posts: 207
  4. CSV/SOFTWARE VALIDATION/THE REGULATED CLOUD Threads / Posts  Last Post

    1. The Regulations and the Predicate Rules.

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      • Threads: 121
      • Posts: 474
    2. Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

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

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      • Threads: 5
      • Posts: 17
    4. COMPLIANCE SOFTWARE

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

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      • Threads: 68
      • Posts: 243
    5. A Risk-Based Approach to Compliant GxP Computerized Systems

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      • Threads: 6
      • Posts: 30
    6. Best Practices - Worst Practices

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      • Threads: 179
      • Posts: 595
    7. 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
    8. Is it Software ? Is it Firmware - The Debate goes on!

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

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      • Threads: 131
      • Posts: 482
  5. INFRASTRUCTURE QUALIFICATION Threads / Posts  Last Post

    1. A robust network is also a well designed network!

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      • Threads: 11
      • Posts: 34
    2. SERVER QUALIFICATION

      (1 Viewing)

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

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      • Threads: 7
      • Posts: 29
  6. SUPPLIER AUDIT / QUALIFICATION Threads / Posts  Last Post

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

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      • Threads: 7
      • Posts: 13
  7. 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: 69
    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: 7
      • Posts: 38
    3. This section has being created to discuss best practices for creating URS documents.

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      • Threads: 28
      • Posts: 85
    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
      • Posts: 24
    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: 29
      • Posts: 90
    8. What type of checks do you include in your PQ

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      • Threads: 83
      • Posts: 287
    9. How do you record your deviations and discrepancies and how do you close them out?

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      • Threads: 24
      • Posts: 117
    10. How detailed is your summary report, what details do you include in it?

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      • Threads: 6
      • Posts: 21
  8. GxP & REGULATORY TOPICS Threads / Posts  Last Post

    1. PART 211 - Current Good Manufacturing Practice

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      • Threads: 351
      • Posts: 1,075
    2. GAP - Good Auditing Practice Discussion Board

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

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      • Threads: 28
      • Posts: 32
    4. GDP - Good Documentation Practice & Documentation Discussion Board

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      • Threads: 64
      • Posts: 308
    5. GEP - Good Engineering Practice Discussion Board

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      • Threads: 73
      • Posts: 258
    6. GLP - Good Laboratory Practice Discussion Board

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      • Threads: 64
      • Posts: 212
    7. Quality Management Systems - ISO 9001:2000

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      • Threads: 49
      • Posts: 194
    8. Quality Systems Regulations - The Law.

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      • Threads: 42
      • Posts: 140
  9. LEARNABOUTGMP.COM Threads / Posts  Last Post

  10. 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
      • Posts: 167
    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: 64
      • Posts: 215
    3. This thread is specially designed for our members to upload white papers of interest.

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      • Threads: 79
      • Posts: 147
    4. PRESENTATIONS

      (2 Viewing)

      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
      • Posts: 28
  11. SIX SIGMA Threads / Posts  Last Post

    1. 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: 135
  12. BIOTECHNOLOGY & BIOPROCESSING Threads / Posts  Last Post

    1. (Component preparation, Formulation, Sterile Filtration & Lyophilization)

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      • Threads: 5
      • Posts: 12
    2. (Process Trends, Disposables & Utility-Facility Design)

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      • Threads: 3
      • Posts: 9
    3. (HPLC,MALDI,Spectroscopy,Electrophoresis,Blotting)

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      • Threads: 4
      • Posts: 7
    4. (Regulatory Updates across globe and Quality assurance)

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      • Threads: 163
      • Posts: 190
    5. (Handling lab,Pilot, Scale-up and Manufacturing operations)

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      • Threads: 3
      • Posts: 7
  13. COMMUNITY CENTER Threads / Posts  Last Post

    1. INDUSTRY NEWS

      (1 Viewing)

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

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      • Threads: 268
      • Posts: 278
    2. Anything that doesn't fit in the main forum, please post it here.

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      • Threads: 363
      • Posts: 1,050

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