Hello Guest! Log In or Register now. Lost Password? Click Here to Reset

Ask About Validation

Loading
Writing & Executing a Software Validation Protocol: Plain and Simple

Writing & Executing a Software Validation Protocol: Plain and Simple


This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results.

While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.



AskaboutValidation forum

Welcome to the AskaboutValidation forum.

  1. FORUM NEWS Threads / Posts  Last Post

    1. NEWS & ANNOUNCEMENTS

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

      Forum Actions:

      Forum Statistics:

      • Threads: 42
      • Posts: 89

      Last Post:

    2. INTRODUCTIONS

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

      Forum Actions:

      Forum Statistics:

      • Threads: 23
      • Posts: 43

      Last Post:

    3. POLLS

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

      Forum Actions:

      Forum Statistics:

      • Threads: 6
      • Posts: 15

      Last Post:

  2. CSV/SOFTWARE VALIDATION/THE REGULATED CLOUD Threads / Posts  Last Post

    1. 21 CFR PART 11

      (1 Viewing)

      The Regulations and the Predicate Rules.

      Forum Actions:

      Forum Statistics:

      • Threads: 112
      • Posts: 452

      Last Post:

    2. 21 CFR PART 820 (The Regulations)

      (1 Viewing)

      Quality Systems Regulations - The Law.

      Forum Actions:

      Forum Statistics:

      • Threads: 40
      • Posts: 135

      Last Post:

    3. COMPLIANCE SOFTWARE

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

      Forum Actions:

      Forum Statistics:

      • Threads: 63
      • Posts: 255

      Last Post:

    4. SOFTWARE VALIDATION DOCUMENTATION

      Questions about CSV Documentation list them here.

      Forum Actions:

      Forum Statistics:

      • Threads: 127
      • Posts: 476

      Last Post:

    5. GOOD COMPUTER SYSTEM VALIDATION

      (1 Viewing)

      Best Practices - Worst Practices

      Forum Actions:

      Forum Statistics:

      • Threads: 170
      • Posts: 565

      Last Post:

    6. SCADA & PLC's

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

      Forum Actions:

      Forum Statistics:

      • Threads: 38
      • Posts: 155

      Last Post:

    7. CLOUD COMPUTING - REGULATED ENVIRONMENT

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

      Forum Actions:

      Forum Statistics:

      • Threads: 5
      • Posts: 17

      Last Post:

  3. INFRASTRUCTURE QUALIFICATION Threads / Posts  Last Post

    1. NETWORK QUALIFICATION

      A robust network is also a well designed network!

      Forum Actions:

      Forum Statistics:

      • Threads: 11
      • Posts: 34

      Last Post:

    2. SERVER QUALIFICATION

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

      Forum Actions:

      Forum Statistics:

      • Threads: 7
      • Posts: 28

      Last Post:

  4. GENERAL VALIDATION & CALIBRATION Threads / Posts  Last Post

    1. HVAC VALIDATION

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

      Forum Actions:

      Forum Statistics:

      • Threads: 37
      • Posts: 161

      Last Post:

    2. GVP - GOOD VALIDATION PRACTICE

      (4 Viewing)

      Good Validation Practice - For Process and Equipment Systems

      Forum Actions:

      Forum Statistics:

      • Threads: 403
      • Posts: 1,520

      Last Post:

    3. PURIFIED WATER VALIDATION

      Applicable Regulations, Standards, and Guidelines, Planning, Design Basics

      Forum Actions:

      Forum Statistics:

      • Threads: 9
      • Posts: 18

      Last Post:

    4. CALIBRATION & METROLOGY

      (2 Viewing)

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

      Forum Actions:

      Forum Statistics:

      • Threads: 10
      • Posts: 21

      Last Post:

    5. PROCESS VALIDATION

      Process Validation

      Forum Actions:

      Forum Statistics:

      • Threads: 139
      • Posts: 412

      Last Post:

    6. METHOD & ANALYTICAL VALIDATION

      Method & Analytical Validation

      Forum Actions:

      Forum Statistics:

      • Threads: 285
      • Posts: 980

      Last Post:

    7. CLEANING VALIDATION

      (4 Viewing)

      Cleaning Validation - what are your methods

      Forum Actions:

      Forum Statistics:

      • Threads: 522
      • Posts: 1,916

      Last Post:

    8. EQUIPMENT VALIDATION

      (1 Viewing)

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

      Forum Actions:

      Forum Statistics:

      • Threads: 269
      • Posts: 939

      Last Post:

  5. RISK ASSESSMENT Threads / Posts  Last Post

    1. RISK ASSESSMENT

      How do you Evaluate Risk?

      Forum Actions:

      Forum Statistics:

      • Threads: 52
      • Posts: 187

      Last Post:

  6. SUPPLIER AUDIT / QUALIFICATION Threads / Posts  Last Post

    1. SUPPLIER AUDIT / QUALIFICATION

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

      Forum Actions:

      Forum Statistics:

      • Threads: 6
      • Posts: 11

      Last Post:

  7. VALIDATION DOCUMENTATION Threads / Posts  Last Post

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

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

      Forum Actions:

      Forum Statistics:

      • Threads: 22
      • Posts: 68

      Last Post:

    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?

      Forum Actions:

      Forum Statistics:

      • Threads: 7
      • Posts: 37

      Last Post:

    3. URS (USER REQUIRMENT SPECIFICATION)

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

      Forum Actions:

      Forum Statistics:

      • Threads: 26
      • Posts: 83

      Last Post:

    4. FDS (FUNCTIONAL DESIGN SPECIFICATION)

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

      Forum Actions:

      Forum Statistics:

      • Threads: 4
      • Posts: 19

      Last Post:

    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?

      Forum Actions:

      Forum Statistics:

      • Threads: 3
      • Posts: 15

      Last Post:

    6. IQ (INSTALLATION QUALIFICATION)

      What type of checks do you include in your IQ

      Forum Actions:

      Forum Statistics:

      • Threads: 29
      • Posts: 92

      Last Post:

    7. OQ (OPERATIONAL QUALIFICATION)

      What type of checks do you include in your OQ

      Forum Actions:

      Forum Statistics:

      • Threads: 26
      • Posts: 81

      Last Post:

    8. PQ (PERFORMANCE QUALIFICATION)

      (1 Viewing)

      What type of checks do you include in your PQ

      Forum Actions:

      Forum Statistics:

      • Threads: 70
      • Posts: 252

      Last Post:

    9. DEVIATION & DISCREPANCY HANDLING

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

      Forum Actions:

      Forum Statistics:

      • Threads: 23
      • Posts: 114

      Last Post:

    10. VSR (VALIDATION SUMMARY REPORT)

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

      Forum Actions:

      Forum Statistics:

      • Threads: 6
      • Posts: 21

      Last Post:

  8. GxP & RELATED TOPICS Threads / Posts  Last Post

    1. cGMP - GOOD MANUFACTURING PRACTICE

      (15 Viewing)

      PART 211 - Current Good Manufacturing Practice

      Forum Actions:

      Forum Statistics:

      • Threads: 339
      • Posts: 1,040

      Last Post:

    2. GAP - GOOD AUDITING PRACTICE - ISO 19011

      (2 Viewing)

      GAP - Good Auditing Practice Discussion Board

      Forum Actions:

      Forum Statistics:

      • Threads: 34
      • Posts: 121

      Last Post:

    3. GCP - GOOD CLINICAL PRACTICES

      (1 Viewing)

      GCP - Good Clinical Practice Discussion Board

      Forum Actions:

      Forum Statistics:

      • Threads: 27
      • Posts: 31

      Last Post:

    4. GDP - GOOD DOCUMENTATION PRACTICE

      GDP - Good Documentation Practice & Documentation Discussion Board

      Forum Actions:

      Forum Statistics:

      • Threads: 60
      • Posts: 296

      Last Post:

    5. GEP - GOOD ENGINEERING PRACTICE

      (1 Viewing)

      GEP - Good Engineering Practice Discussion Board

      Forum Actions:

      Forum Statistics:

      • Threads: 70
      • Posts: 249

      Last Post:

    6. GLP - GOOD LABORATORY PRACTICE

      GLP - Good Laboratory Practice Discussion Board

      Forum Actions:

      Forum Statistics:

      • Threads: 62
      • Posts: 208

      Last Post:

    7. QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000

      Quality Management Systems - ISO 9001:2000

      Forum Actions:

      Forum Statistics:

      • Threads: 48
      • Posts: 191

      Last Post:

  9. ASKABOUTVALIDATION BOOKS Threads / Posts  Last Post

    1. NEW RELEASES

      Get the scoop on AskAboutValidation's latest book releases!

      Forum Actions:

      Forum Statistics:

      • Threads: 11
      • Posts: 11

      Last Post:

    2. FEEDBACK & REVIEWS

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

      Forum Actions:

      Forum Statistics:

      • Threads: 1
      • Posts: 4

      Last Post:

    3. QUESTIONS ABOUT BOOKS

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

      Forum Actions:

      Forum Statistics:

      • Threads: 3
      • Posts: 9

      Last Post:

  10. USEFUL VALIDATION STUFF Threads / Posts  Last Post

    1. GENERAL VALIDATION DEFINITIONS

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

      Forum Actions:

      Forum Statistics:

      • Threads: 79
      • Posts: 167

      Last Post:

    2. VALIDATION TEMPLATES

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

      Forum Actions:

      Forum Statistics:

      • Threads: 53
      • Posts: 172

      Last Post:

    3. WHITE PAPERS

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

      Forum Actions:

      Forum Statistics:

      • Threads: 79
      • Posts: 147

      Last Post:

    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

      Forum Actions:

      Forum Statistics:

      • Threads: 9
      • Posts: 28

      Last Post:

  11. SIX SIGMA Threads / Posts  Last Post

    1. SIX SIGMA FORUM

      (2 Viewing)

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

      Forum Actions:

      Forum Statistics:

      • Threads: 42
      • Posts: 130

      Last Post:

  12. BIOTECHNOLOGY & BIOPROCESSING Threads / Posts  Last Post

    1. BIOPHARMACEUTICAL FILL TO FINISH

      (Component preparation, Formulation, Sterile Filtration & Lyophilization)

      Forum Actions:

      Forum Statistics:

      • Threads: 5
      • Posts: 12

      Last Post:

    2. BIOPROCESSING TECHNOLOGY & DESIGN ASPECTS

      (Process Trends, Disposables & Utility-Facility Design)

      Forum Actions:

      Forum Statistics:

      • Threads: 3
      • Posts: 9

      Last Post:

    3. BIOANALYTICAL TECHNIQUES

      (HPLC,MALDI,Spectroscopy,Electrophoresis,Blotting)

      Forum Actions:

      Forum Statistics:

      • Threads: 4
      • Posts: 7

      Last Post:

    4. REGULATORY TRENDS & QA

      (Regulatory Updates across globe and Quality assurance)

      Forum Actions:

      Forum Statistics:

      • Threads: 124
      • Posts: 147

      Last Post:

    5. UPSTREAM & DOWNSTREAM PROCESSING

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

      Forum Actions:

      Forum Statistics:

      • Threads: 3
      • Posts: 6

      Last Post:

  13. COMMUNITY CENTER Threads / Posts  Last Post

    1. INDUSTRY NEWS

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

      Forum Actions:

      Forum Statistics:

      • Threads: 205
      • Posts: 212

      Last Post:

    2. GENERAL DISCUSSIONS

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

      Forum Actions:

      Forum Statistics:

      • Threads: 360
      • Posts: 1,043

      Last Post:

Mark Forums Read | View Forum Leaders

What's Going On?

Currently Active Users

There are currently 49 users online. 1 members and 48 guests

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

  1. Hanks

Today's Birthdays

  1. Today's Birthdays —
  2. bk320679 (35)

AskaboutValidation forum Statistics

Threads
4,236
Posts
13,650
Members
24,868

Welcome to our newest member, sigem555

SITE MAP

Useful Information

Our Network

Get In Touch with AskaboutValidation

© 2006 - 2012 askaboutvalidation. All Rights Reserved
Single Sign On provided by vBSSO