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An Easy To Understand Guide

An Easy to understand guide to good documentation practices (gop) is a no-nonsense approach to performing handwritten entries into formal, regulated documentation. The book was born after many years of complaining about inconsistencies about the documentation practices that we encountered as a company.

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157 views10 pages

An Easy To Understand Guide

An Easy to understand guide to good documentation practices (gop) is a no-nonsense approach to performing handwritten entries into formal, regulated documentation. The book was born after many years of complaining about inconsistencies about the documentation practices that we encountered as a company.

Uploaded by

dilic7
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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An Easy to Understand Guide

Good Documentation
Practices (GDP)

askaboutValidation
The Validation Specialists Connecting the Lifesciences
BLANK PAGE

An Easy to Understand Guide Good Documentation Practice


Good Documentation Practices

First Edition

© Copyright 2010 Premier Validation

All rights reserved. No part of the content or the design of this book maybe
reproduced or transmitted in any form or by any means without the express
written permission of Premier Validation.

Visit Premier Validation on the web at www.premiervalidation.com

ISBN 0111-2323232-44-5

An Easy to Understand Guide Good Documentation Practice


Forward by Mark Richardson
This book was born after many years of complaining about
inconsistencies about the documentation practices that we encountered as
a company both internally and externally. Being an organization that
provides services to primarily biotech and pharmaceutical companies across
the globe we found that it was nearly impossible to achieve a happy medium
of understanding documentation across the board.

We have internal procedures, so did our clients, nothing was consistent


and whilst everyone strived to be correct a lack of understanding would
inevitably arise, things were questioned. Of course, we weren't adverse to
things being challenged in the workplace – far from it and often (more often
than not) when things were challenged they we proven to be already correct
we still found that inconsistencies caused project delays.

A small group of us at Premier Validation decided that these


inconsistencies could be replaced with consistencies and that our moaning
could be replaced by happy chants of fulfilment if everyone (or at least a
proportion of people in the industry) was singing from the same hymn sheet,
or at least performing documentation entries in a consistent format that
would be understood by our neighbours at home as easily as our cousins
across the pond or from down-under; or even on Mars.

An Easy to Understand Guide Good Documentation Practice


The moaning was replaced with buzzing as a new project was born; a
small team of experts formed to develop the Premier Validation Good
Documentation Practices (GDP) eBook, which has subsequently been
transformed into this very book in your hands. This is a no-nonsense
approach to performing handwritten entries into formal, regulated
documentation; this non-fiction guide is useful for any regulated industry
and for life in general. If nothing else, a tidy mind helps to keep a tidy,
clutter-free life – something from which we all benefit.

The benefits of this book can even be felt outside of the office – even at
home, when one makes notes a letter – “just in case” only to discover 5 years
later when having a clear-out that: “Wait there, I wrote this – what on Earth
(or Mars) does this actually mean? Is this a date, a reference number, a time
for an appointment?” Sound familiar?

This book was written with the current regulations and practices of
performing handwritten entries at the forefront of the content and I
apologize now for any errors, omissions or for any content that is not longer
current and if you find any of these I would be more than happy to hear from
you, not least because you've taken the time to buy our very first book, but
for the fact you've read my preface and if you've got this far I'm hoping I have
at least made a half-decent effort, but all joking-aside we want this book to
be successful and our readers to be happy with the content and all
comments will be taken very seriously whether they're implemented or not.

An Easy to Understand Guide Good Documentation Practice


Being our first book, we went around the houses a bit to get to a state
that we felt that we had reached completion – our review, although
structured and included many experts could have been tabled to flow a little
more smoothly, a key lesson learned for the following software validation
book that is due out in September 2010, we got there in the end (we think)
and we hope that you will enjoy our book as much as we enjoyed putting it
together and that enjoy the benefits as well as the read.

An Easy to Understand Guide Good Documentation Practice


Acknowledgements
The position that we are currently in owes a lot of debt to Graham
O'Keeffe, the driving force behind the book and without his eye for graphics,
this book simply wouldn't be where it is today, also Darren Grant brought a
great practical insight into the usage of the book from a user point of view
that seen the removal of a lot of jargon and the simplification of many
technical terms. Mark Richardson was instrumental in the streamlining of
the content in conjunction with his objective reviewing based on a lifetime
of applying such Good Documentation Practices within the industry.

A special thank-you to the original content author Don Hurd for the
time and effort he put into producing the original transcript, although the
whole team will agree that the finished product is very different now, it was
Don who put the initial framework together capturing all of the critical
elements.

Finally, we are also indebted to our graphic designer Louis Je Tonno and
content author Anne-Marie Smith who went through the way the book was
written and made it read with consistency, using a fine tooth-comb Anne-
Marie meticulously went through our final draft and edited the language,
tone and flow of the book to make it into the product that you're reading
now.

An Easy to Understand Guide Good Documentation Practice


Table of Contents
The Starting Line
What is GDP? 2
Benefits of GDP 4
Why Should I Read This e-Book? 5

General Rules
Document Types 8
Signatures 9
Date and Time Formats 11
Language 13
Use Indelible Ink 15
Scraps and Post Its 16
Transcribing 17
Late Entries 18
Blank Fields 19
Additional Pages 20
Instrument Print Out 21
Ditto 22

An Easy to Understand Guide Good Documentation Practice


Corrections
Making Corrections 24
Draw a Line 25
Correction Tape and Fluids 26
Explanations for the Correction 27
Re-Verification 28
Multiple Corrections 29
Avoid Asterisks 30

Logbooks
What Are Logbooks and Why Use Them? 32
Elements of a Logbook 33
Assigning Logbooks 34
Reviewing Recorded Data 35
Retrieving Logbooks 36
Logbook Auditing 37
Signature Blocks 38
Page Numbering 39
Never Remove Pages 39
Avoid Gaps 40
Print Outs 42

An Easy to Understand Guide Good Documentation Practice


General Test Results
Protocol Generation 44
Variable Data 45
Errors Can Be Costly 46
Expected Results 48
Calculations or Formulas 49
Redline the Changes 51
Accountability 52
Rules of Thumb 53
Units of Measurement 54
Legal Factors (including similarity with ERES*) 55
* Electronic Records/Electronic Signatures

To Sum It Up
What You Learned 58

An Easy to Understand Guide Good Documentation Practice

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