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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.



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

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    2. INTRODUCTIONS

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

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

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

    1. GAMP® 5

      A Risk-Based Approach to Compliant GxP Computerized Systems

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    2. 21 CFR PART 11

      The Regulations and the Predicate Rules.

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    3. 21 CFR PART 820 (The Regulations)

      Quality Systems Regulations - The Law.

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    4. COMPLIANCE SOFTWARE

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

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    5. SOFTWARE VALIDATION DOCUMENTATION

      (1 Viewing)

      Questions about CSV Documentation list them here.

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      • Threads: 128
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    6. GOOD COMPUTER SYSTEM VALIDATION

      Best Practices - Worst Practices

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      • Threads: 171
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    7. SCADA & PLC's

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

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    8. CLOUD COMPUTING - REGULATED ENVIRONMENT

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

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  3. INFRASTRUCTURE QUALIFICATION Threads / Posts  Last Post

    1. NETWORK QUALIFICATION

      A robust network is also a well designed network!

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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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  4. GENERAL VALIDATION & CALIBRATION Threads / Posts  Last Post

    1. HVAC VALIDATION

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

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    2. GVP - GOOD VALIDATION PRACTICE

      Good Validation Practice - For Process and Equipment Systems

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    3. PURIFIED WATER VALIDATION

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

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    4. CALIBRATION & METROLOGY

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

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    5. PROCESS VALIDATION

      Process Validation

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    6. METHOD & ANALYTICAL VALIDATION

      (2 Viewing)

      Method & Analytical Validation

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    7. CLEANING VALIDATION

      Cleaning Validation - what are your methods

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    8. EQUIPMENT VALIDATION

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

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  5. RISK ASSESSMENT Threads / Posts  Last Post

    1. RISK ASSESSMENT

      (1 Viewing)

      How do you Evaluate Risk?

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  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.

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  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?

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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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    3. URS (USER REQUIRMENT SPECIFICATION)

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

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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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    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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    6. IQ (INSTALLATION QUALIFICATION)

      What type of checks do you include in your IQ

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    7. OQ (OPERATIONAL QUALIFICATION)

      What type of checks do you include in your OQ

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    8. PQ (PERFORMANCE QUALIFICATION)

      (1 Viewing)

      What type of checks do you include in your PQ

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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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    10. VSR (VALIDATION SUMMARY REPORT)

      (1 Viewing)

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

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  8. GxP & RELATED TOPICS Threads / Posts  Last Post

    1. cGMP - GOOD MANUFACTURING PRACTICE

      (6 Viewing)

      PART 211 - Current Good Manufacturing Practice

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    2. GAP - GOOD AUDITING PRACTICE - ISO 19011

      GAP - Good Auditing Practice Discussion Board

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    3. GCP - GOOD CLINICAL PRACTICES

      GCP - Good Clinical Practice Discussion Board

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    4. GDP - GOOD DOCUMENTATION PRACTICE

      GDP - Good Documentation Practice & Documentation Discussion Board

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    5. GEP - GOOD ENGINEERING PRACTICE

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      GEP - Good Engineering Practice Discussion Board

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    6. GLP - GOOD LABORATORY PRACTICE

      GLP - Good Laboratory Practice Discussion Board

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    7. QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000

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      Quality Management Systems - ISO 9001:2000

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  9. ASKABOUTVALIDATION BOOKS Threads / Posts  Last Post

    1. NEW RELEASES

      Get the scoop on AskAboutValidation's latest book releases!

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    2. FEEDBACK & REVIEWS

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

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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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  10. USEFUL VALIDATION STUFF Threads / Posts  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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    2. VALIDATION TEMPLATES

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

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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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    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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  11. SIX SIGMA Threads / Posts  Last Post

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

    1. BIOPHARMACEUTICAL FILL TO FINISH

      (Component preparation, Formulation, Sterile Filtration & Lyophilization)

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    2. BIOPROCESSING TECHNOLOGY & DESIGN ASPECTS

      (Process Trends, Disposables & Utility-Facility Design)

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    3. BIOANALYTICAL TECHNIQUES

      (HPLC,MALDI,Spectroscopy,Electrophoresis,Blotting)

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    4. REGULATORY TRENDS & QA

      (Regulatory Updates across globe and Quality assurance)

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    5. UPSTREAM & DOWNSTREAM PROCESSING

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

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  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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    2. GENERAL DISCUSSIONS

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

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