Hello Guest! Log In or Register now. Lost Password? Click Here to Reset
You have items in your shopping cart
Proceed to checkout
our books
-
Writing & Executing a Software Validation Protocol: Plain and Simple
by Premier ValidationThis 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.
-
An Easy to Understand Guide to GDP
by Premier ValidationGDP is an essential skill you need to have when you’re working in the life science sector. GDP is not just about initials and dates (although it does play a big part of it) it’s about doing things the right way and making everything you do transparent. Honesty is the best policy and when you’re making medicinal products its essential you follow the rules.
-
An Easy to Understand Guide to Equipment Qualification
by Premier ValidationThis book describes how to perform the qualification assessment depending upon the impact of individual equipment on product quality. The risk based qualification assessment describes the qualification steps (RA,DQ, IQ, OQ, PQ etc.) required to qualify the equipment. This approach eliminates the duplication of effort and costly practices.
-
An Easy to Understand Guide to Validating Purified Water Systems
by Premier ValidationThis quick and easy guide describes how to design, build, and validate a purified water treatment system according to current quality regulations and standards. You will find this guide especially helpful if you are in the planning phase for a new purified water treatment system, interested in upgrading your current system and new to water treatment projects.
-
An Easy to Understand Guide to Supplier Qualification
by Premier ValidationNot all suppliers are the same, for example when you buy a car or a house, time and effort is dedicated into finding the best provider with the best product in terms of quality and reliability. The same methodology needs to be dedicated when choosing a vendor for your business. Not only will you be purchasing their products or services, but you will also be dealing with them on a regular basis hence your personal relationship most also be strong.
-
The Principles of a Software Validation Life Cycle
by Premier ValidationWriting a software validation test script can be a difficult task to someone who has never done it before. That’s why we felt it was about time we went back to basics and explained in simple terms the correct sequence of events. From gathering requirements to finally executing the test script, there are a number of steps in-between if followed will allow you to produce a quality test script with a minimum amount of errors.
-
An Easy to Understand Guide to Software Validation
by Premier ValidationSoftware validation simplified — seriously. You will be amazed and relieved to know there really is an easy way to learn about software validation. This book is for anyone working in a regulated environment that wants to learn more about software validation. Written in a clear concise manner, we can guarantee that this wonderful book will bring you up to speed very quickly.
-
An Easy to Understand Guide to HVAC Validation
by Premier ValidationThis book will provide an insight into the complexity of HVAC systems and their designs, and how these systems can be tested and verified. HVAC’s are present in every regulated environment from Biotechnology to Pharmaceutical so it is well worth putting a little time into finding out more about how they work.
-
An Easy to Understand Guide to Cleaning Validation
by Premier ValidationThis book describes how to comply with equipment cleaning validation regulations and guidelines successfully for activities related to or in support of the manufacture of drug products and substances (and their associated components produced for consumption by humans and animals).
-
An Easy to Understand Guide to Annex 11
by Premier ValidationThe usual reaction when someone brings up the term Annex 11 is that people just gloss over it and focus on what they deem more important, which is 21 CFR Part 11. However if you work in a facility that is not manufacturing product for the US market, but for the European market then Annex 11 is the regulation you must adhere to.
-
An Easy to Understand Guide to 21 CFR Part 11
by Premier ValidationThe usual reaction when someone brings up the term Annex 11 is that people just gloss over it and focus on what they deem more important, which is 21 CFR Part 11. However if you work in a facility that is not manufacturing product for the US market, but for the European market then Annex 11 is the regulation you must adhere to.
what readers says
-
A novel way to recap on the basics of 21 CFR Part 11!
Kelly Bruening | Axial Biotech
-
At last I can now test my software applications and actually understand the Part 11 sections.
Pearlie Stabler | BioBalance
-
Why couldn't the FDA write all their regulations like this!
Amie Schauwecker | BiPar Sciences
-
The guys at askaboutvalidation.com have done another amazing job, well done.
Fernando Whiddon | Carma Laboratories
-
What a life saver, for our software development company.
Roslyn Lunceford | Catalyst Biosciences
Also available on amazon
contact details