Introduction

Whether your system is based on Good Manufacturing Practice or ISO 9000 or both, proper documentation is the cornerstone of your quality system. Documentation Systems: Clear and Simple shows you, step-by-step, how to develop, distribute, and maintain your specifications, protocols, procedures, and other functional documentation.

Frequently asked questions, factoids, a glossary, an appendix of examples, and references complete this valuable resource for QA/QC, Regulatory, and other professionals concerned with training and/or understanding, organizing, managing, and maintaining an efficient and effective documentation system.

Preface

"If it isn't written down, it's just a rumor."

That quote, repeatedly given by FDA and quality assurance professionals, is the underlying reason for this book: to be in a state of control, instructions and requirements must be formally written down. Records that can help someone reconstruct an event or decision need to be properly prepared.

Documentation is the cornerstone of a quality system, whether the system is based on Good Manufacturing Practices or ISO-9000. Not only do you need to have documents like specifications, protocols, and procedures, these functional documents must be developed, distributed, and maintained using a formalized process that is carefully controlled.

If you've been lucky to be audited by a governmental revenue agency (like the United States Internal Revenue Service or Revenue Canada), you probably have experienced their expectations for records. Well organized, detailed receipts are a taxpayer's best friend during an audit. If it isn't written down, you have no way to show it really happened. The same holds true for records in developing, manufacturing, and testing medical devices, drugs, and biologicals. These documents must clearly explain what was done and justify the release of the product into the marketplace.

This was a difficult book to write. Or, more precisely, it was difficult figuring out what not to write in this book. The subject of documentation and record keeping, as it applies to the pharmaceutical and medical device industries could easily consume several volumes. This book is based on a workshop that I have given to firms and groups throughout the United States, Canada, Asia, and Europe. In many of these courses, I have had the opportunity to collaborate with two friends and colleagues, Art Mlodozeniec and Farrow Beacham. Each time we have given the workshop, we've covered a core set of content, but then, based on the participants and their desires, we go off in a variety of directions, covering things from LIMS systems to the role of management in documentation programs.

This book is written for:

• People new to the area of documentation;

• People new to the pharmaceutical, medical device, and biologics industries;

• People who are not documentation specialists but need to audit such areas; and

• Practitioners in the field who require a reference.

The selection of content was made with an emphasis on the systems aspect of documentation and record keeping that can be applied in the widest number of situations.

As you read, you may discover two biases of mine. First, that documentation and record keeping are not and should not be viewed as a pain in the neck. Rather, they are things that should help the organization accomplish its goals. The second bias is that functional documents, particularly procedures and methods, need to be created with thought given at the outset to training.

One caution with this book -- it is the same caution we give to the workshop participants. You will not find any magic answers here. You won't find ways to cut your document library by one-half, or reduce the number of documentation coordinators at your firm by 40 percent. You may in fact discover you need more procedures or that more people have to be involved in the process. Since documentation systems are one of the most complex components of your firm's quality system, this must be expected. Your goal, however, must be constantly kept in mind: to help capture the knowledge of your firm and replace rumors with facts.

Jim Vesper
July 1997

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