Software validation can encompass a wide range of software applications ranging from very simple to very complex. In many regulated environments, both product software and software that could impact product software quality are expected to be validated. Product software ranges from embedded, real-time applications to desktop analysis applications, to web-based image processing applications. Boiled down, though, the intent is the same for all applications.

Who Should Read This Book?

At around 73 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about software validation protocols or want to brush up on your current knowledge this book is made for you! We’ve broken down this book into 9 key sections:

• Scope
• Documentation Infrastructure
• Getting Organized
• Protocol Development
• Preparing for and Executing the Protocols
• Recording Results
• Test Development Considerations
• Protocol Types
• Other Protocol Formats

Why Buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of Writing & Executing a Software Validation Protocol: Plain and Simple and you think it falls short of being everything you wanted, we’d like you to have your money back. Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling. What could be fairer than this?

About the Author

Don Hurd has over 30 years of experience in supporting development of real-time, embedded applications in regulated environments. He is an ASQ Certified Quality Auditor with diverse background providing a unique insight into achieving product quality and ensuring high productivity of development organizations. As VP Quality and Validation Services, he has ensured activities are always performed to meet product specifications and that all products and services delivered with the highest possible quality.

His pragmatic approach allows projects to adapt processes to best suit customer and project needs without sacrificing quality or compliance. Mr. Hurd holds a Bachelor of Science Degree in Computer Science from Texas A&M University, College Station, TX. He is an active member of the American Society for Quality (ASQ), holding leadership positions in both the Dallas/Fort Worth Biomedical Discussion Group and the Audit Special Interest Group (SIG).

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If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016 Looking forward to hearing from you!

The book will teach you all you need to know about Good Documentation Practices.The use of GDP is required in both the U.S. and Europe by governing bodies, including FDAs CFR and EMEAs Eudralex. Any documentation that is used in support of manufacturing, laboratory, distribution, and clinical practices must adhere to GDP

Controlled documents are legal documents used in regulated environments that must be signed by the document's author(s) and approved by the appropriate governing body. Document dates must have an appropriate meaning and those signing the documents must be qualified for the content they are approving. The integrity of controlled documents should never be under question. Control must be shown at all times so that the content can withstand legal scrutiny.

Who Should Read This Book?

At around 65 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about Good Documentation Practices or want to brush up on your current knowledge this book is made for you!

We’ve broken down this book into five key sections:

• The Starting Line
• General Rules
• Corrections
• Logbooks
• General Test Results

Why buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to GDP and you think it falls short of being everything you wanted, we’d like you to have your money back.

Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling.

What could be fairer than this?

About the Author

Don Hurd has over 30 years of experience in supporting development of real-time, embedded applications in regulated environments. He is an ASQ Certified Quality Auditor with diverse background providing a unique insight into achieving product quality and ensuring high productivity of development organizations. As VP Quality and Validation Services, he has ensured activities are always performed to meet product specifications and that all products and services delivered with the highest possible quality.

His pragmatic approach allows projects to adapt processes to best suit customer and project needs without sacrificing quality or compliance. Mr. Hurd holds a Bachelor of Science Degree in Computer Science from Texas A&M University, College Station, TX. He is an active member of the American Society for Quality (ASQ), holding leadership positions in both the Dallas/Fort Worth Biomedical Discussion Group and the Audit Special Interest Group (SIG).

Contact Us

If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016

Looking forward to hearing from you!

Upon the completion of this book you will be able to understand the basic difference between validation & qualification terms, discuss the principles of equipment qualification, understand regulatory requirements and expectations, understand impact based qualification need assessment approach, understand risk Based equipment qualification approach, understand equipment qualification documentation and much more…

Who Should Read This Book?

At around 70 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about equipment qualification or want to brush up on your current knowledge this book is made for you! We’ve broken down this book into 24 key sections:

• Terms Explained
• Qualification versus Validation
• What are the Benefits of Equipment Qualification?
• Qualification Planning
• Risk Based Impact Assessment - Qualification
• Need Assessment
• User Requirement Specification (URS)
• Risk Assessment
• What is FAT/SAT?
• Equipment Design Qualification (DQ)
• Equipment Installation qualification (IQ)
• Equipment Operational Qualification (OQ)
• Equipment Performance Qualification (PQ)
• Requalification
• Change Control

Why Buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to Equipment Qualification and you think it falls short of being everything you wanted, we’d like you to have your money back. Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling. What could be fairer than this?

About the Author

Joginder Mittal M.Sc (Microbiology); MBA, is a pharmaceutical GMP Expert with years of extensive experience in cGMP aspects required during designing and setting up of Manufacturing Plants / Laboratories / R & D units. He has been involved in various projects for qualification activities, setting up of Quality Management System, GMP Audits and GAP Analysis.

He has handled the projects for Multi Product Oral Solid Dosage Manufacturing Facility, Large Volume Parenteral Facility, Small Volume Parenteral Facility and Consumer Healthcare Product Facility. His validation experience includes development of Facility Risk Management Plan, Validation Master Plans, Risk based Equipment Qualification, Validation Protocols Package for Facility, Process, Utilities and Computer System Validation (GAMP 5).

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If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016 Looking forward to hearing from you!

This quick and easy guide describes how to design, build, and validate a purified water treatment system according to current quality regulations
and standards. This guide begins at the incoming water into a facility, which should be of drinking quality, and ends with the distribution points of the purified water system. and much more…

Who Should Read This Book?

At around 110 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about purified water validation or want to brush up on your current knowledge this book is made for you! We’ve broken down this book into 9 key sections:

• Applicable Regulations, Standards, and Guidelines
• Planning
• Design Basics
• Component Procurement System
• System Quality
• Validation
• System Turnover Package
• Change Control
• Maintenance and Service

Why Buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to Validating Purified Water Systems and you think it falls short of being everything you wanted, we’d like you to have your money back. Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling. What could be fairer than this?

About the Author

Annelie has a background in Chemical Engineering (4-year upper secondary school) and has been working within the Biotech and Pharmaceutical industry for 15 years and has a long experience of international clean utility projects as QA, Validation Manager and Project Manager.

She has been working with Project Management, Design reviews, Procurement specifications, Receiving inspections, Mechanical inspections and testing, Validation protocols and execution.
She also trained and supervised other groups (Validation engineers, Electrical engineering, Automation, etc) in Good Automation Manufacturing Procedure, GDP and testing performance.

Published article: Practical guidelines for qualifying Purified water systems in the Magazine Pharmaceutical Technology Europe, Vol 19 Issue 12, 2007.

Contact Us

If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016 Looking forward to hearing from you!

Upon the completion of this book you will be able to understand the basic difference between validation & qualification terms, discuss the principles of equipment qualification, understand regulatory requirements and expectations, understand impact based qualification need assessment approach, understand risk Based equipment qualification approach, understand equipment qualification documentation and much more…

Who Should Read This Book?

At around 35 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about equipment qualification or want to brush up on your current knowledge this book is made for you! We’ve broken down this book into 7 key sections:

• Identify Your Suppliers
• Determine if Supplier Affect Quality
• That Potentially Impact Quality, Determine the Risk
• Based on Risk, Determine the Level of Qualification Needed
• Determine Qualification Criteria
• Perform Qualification Activities
• Select Supplier(s) Based on Qualifications

Why Buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to Supplier Qualification and you think it falls short of being everything you wanted, we’d like you to have your money back. Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling. What could be fairer than this?

About the Author

Don Hurd has over 30 years of experience in supporting development of real-time, embedded applications in regulated environments. He is an ASQ Certified Quality Auditor with diverse background providing a unique insight into achieving product quality and ensuring high productivity of development organizations. As VP Quality and Validation Services, he has ensured activities are always performed to meet product specifications and that all products and services delivered with the highest possible quality.

His pragmatic approach allows projects to adapt processes to best suit customer and project needs without sacrificing quality or compliance. Mr. Hurd holds a Bachelor of Science Degree in Computer Science from Texas A&M University, College Station, TX. He is an active member of the American Society for Quality (ASQ), holding leadership positions in both the Dallas/Fort Worth Biomedical Discussion Group and the Audit Special Interest Group (SIG).

Contact Us

If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016.

Looking forward to hearing from you!

This guide has been developed to provide a basic overview of a simple software validation life cycle detailing the clear correlation between user requirements and how they can be tested in a validation protocol. This introductory guide will help anyone new to the life science validation field and those who want to recap on their skills.

Who Should Read This Book?

At around 40 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about a software validation life cycle or want to brush up on your current knowledge this book is made for you! We’ve broken down this book into 8 key sections:

• Requirement Gathering
• Develop a User Requirement Specification (URS)
• Develop a Functional Design Specification (FDS)
• Test the application before developing your script
• Develop the Test Script
• Dry Run the Test Script
• Execute the Test Script
• Reports the Results

Why Buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of The Principles of a Software Validation Life Cycle and you think it falls short of being everything you wanted, we’d like you to have your money back. Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling. What could be fairer than this?

Contact Us

If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016 Looking forward to hearing from you!

This book addresses how software validation can be applied to any computerised systems used in a regulated environment, and how you can apply a solid validation process. The validation procedures in this book address software that is vendor-supplied, commercial off the shelf (COTS), internally developed software or a hybrid (customized COTS software). Software validation can be a complicated subject, but we’ve managed to break it down so anyone can learn about the principles and how to apply them.

Our easy to understand guide is just that, and we’re confident that after reading this book you will be more than capable to take on a software validation project with ease.

Who Should Read This Book?

At around 100 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about software validation or want to brush up on your current knowledge this book is made for you!

We’ve broken down this book into five key sections:

• Planning for Validation
• Validation Protocols
• Validation Execution
• Maintaining the Validated State
• Special Considerations

Why buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to Software Validation and you think it falls short of being everything you wanted, we’d like you to have your money back.

Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling.

What could be fairer than this?

About the Author

Don Hurd has over 30 years of experience in supporting development of real-time, embedded applications in regulated environments. He is an ASQ Certified Quality Auditor with diverse background providing a unique insight into achieving product quality and ensuring high productivity of development organizations. As VP Quality and Validation Services, he has ensured activities are always performed to meet product specifications and that all products and services delivered with the highest possible quality.

His pragmatic approach allows projects to adapt processes to best suit customer and project needs without sacrificing quality or compliance. Mr. Hurd holds a Bachelor of Science Degree in Computer Science from Texas A&M University, College Station, TX. He is an active member of the American Society for Quality (ASQ), holding leadership positions in both the Dallas/Fort Worth Biomedical Discussion Group and the Audit Special Interest Group (SIG).

Contact Us

If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016

Looking forward to hearing from you!

Environmental control is a very important part of any life science facility. The Heating, Ventilation & Air Conditioning (HVAC) system helps to ensure proper environmental conditions for your processes—whether in production, quality control, or research and development.

The greater your cleanliness requirements, the greater the importance of the HVAC system. The HVAC system also plays a large part in providing a comfortable working environment, with desired temperature and an influx of fresh air.

Who Should Read This Book?

At around 85 pages, this book is an easy read. As you move through the book, you will quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about HVAC validation or want to brush up on your current knowledge this book is made for you!

We’ve broken down this book into twelve key sections:

• HVAC System Basics
• HVAC System Design Requirements
• Design Considerations
• Drawings
• Your Design and Risk Assessment
• Design Review
• What to Verify
• Prerequisites
• Preparing a Test Protocol
• Requirements Traceability Matrix (RTM)
• Verification Procedures
• Verification of Performance

Why buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to Cleaning Validation and you think it falls short of being everything you wanted, we’d like you to have your money back.

Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling.

What could be fairer than this?

Contact Us

If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016

Looking forward to hearing from you!

Upon the completion of this book you will be able to, discuss the principles of cleaning validation, understand regulatory requirements and expectations, understand validation requirements, decide which equipment and process require validation, review testing methods used for cleaning process validation, understand different sampling methods, determine cleaning validation acceptance criteria, develop cleaning validation protocols for cleaning processes, create validation reports and understand the need to maintain a validated status.

Who Should Read This Book?

At around 82 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about cleaning validation or want to brush up on your current knowledge this book is made for you!

We’ve broken down this book into 24 key sections:

• What is Cleaning Validation?
• Regulatory Requirements
• The Scope of Cleaning Validation
• The Cleaning Validation Sequence
• Pre-requisites
• Cleaning Validation Strategy, Plan & Policy
• Sampling
• Recovery Studies
• Analytical Method Selection and Development
• Analytical Method Validation
• Acceptance Criteria
• Cleaning Method Development
• Validation Master Plan
• Cleaning Validation Plan
• Cleaning Process Standard Operating Procedures (SOP)
• Cleaning Validation Protocols
• Protocol Execution
• Deviations
• Clean and Dirty Hold Times
• Validation Report
• Post Validation Monitoring
• Maintaining the Validated Status
• Retrospective Cleaning Validation

Why buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to Cleaning Validation and you think it falls short of being everything you wanted, we’d like you to have your money back.

Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling.

What could be fairer than this?

Contact Us

If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016

Looking forward to hearing from you!

This book examines the released final version of Annex 11 for computerized systems and provides my recommendations to implement Annex 11. There are many other ways to implement the same requirements. For the purpose of bringing up to the reader additional information, it is referenced relevant regulations/guidelines.

The purpose of this book is not to find gaps between Annex 11 and the referenced regulations. Some descriptions are based on listed guidelines with judicious editing were necessary to fit the context of this book.

Who Should Read This Book?

At around 76 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about Annex 11 or want to brush up on your current knowledge this book is made for you!

We’ve broken down this book into 17 key sections:

• Risk Management
• Personnel
• Suppliers and Service Providers
• Validation
• Data
• Accuracy Checks
• Data Storage
• Printouts
• Audit Trails
• Change and Configuration Management
• Periodic Evaluation
• Security
• Incident Management
• Electronic Signatures
• Batch Release
• Business Continuity
• Archiving

Why buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to Annex 11 and you think it falls short of being everything you wanted, we’d like you to have your money back.

Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling.

What could be fairer than this?

About the Author

Orlando López has over 25 years of software quality assurance experience and more than 18 years in QA and Compliance in the Food and Drug Administration and EU regulated environment. He is a member of the Pharmaceutical Engineering Editorial Review Board.

His special interest is the GMP compliance issues applicable to computer systems.

Orlando is the author of 2 books: “21 CFR Part 11 - A Complete Guide to International Compliance,” published by Sue Horwood Publishing Limited, www.crcpress.com; and “Computer Infrastructure Qualification for FDA Regulatory Industries” published by Davis Healthcare International Publishing, www.euromed.uk.com.

Contact Us

If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016

Looking forward to hearing from you!

The book will teach you all you need to know about 21 CFR Part 11.21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration's (FDA) guidelines on using electronic records (e-recs) and electronic signatures (esigs).

Part 11, as it's commonly called, defines the criteria under which electronic records and electronic signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. Currently, the scope of this regulation is all FDA program areas.

Who Should Read This Book?

At around 72 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about 21 CFR Part 11 or want to brush up on your current knowledge this book is made for you!

We’ve broken down this book into ten key sections:

• The Starting Point
• E-Sigs and E-Recs Explained
• General Rules of System Access
• E-Signatures
• Documentation and Regulatory Controls
• The Difference between Open and Closed Systems
• Computer System Validation
• Audit Trails
• E-Records
• Hybrid and Legacy Systems

Why buy from AskaboutValidation?

Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to 21 CFR Part 11 and you think it falls short of being everything you wanted, we’d like you to have your money back.

Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling.

What could be fairer than this?

About the Author

Orlando López has over 25 years of software quality assurance experience and more than 18 years in QA and Compliance in the Food and Drug Administration and EU regulated environment. He is a member of the Pharmaceutical Engineering Editorial Review Board.

His special interest is the GMP compliance issues applicable to computer systems.

Orlando is the author of 2 books: “21 CFR Part 11 - A Complete Guide to International Compliance,” published by Sue Horwood Publishing Limited, www.crcpress.com; and “Computer Infrastructure Qualification for FDA Regulatory Industries” published by Davis Healthcare International Publishing, www.euromed.uk.com.

Contact Us

If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016

Looking forward to hearing from you!