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100   $a20091008d2010      uy             0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 10$aManaging the documentation maze$b[electronic resource] $eanswers to questions you didn't even know to ask /$fJanet Gough, David Nettleton
205   $a1st edition
210   $aHoboken, N.J. $cWiley$dc2010
215   $a1 online resource (486 p.)
300   $aIncludes index.
311   $a0-470-46708-8 
320   $aIncludes bibliographical references and index.
327   $aMANAGING THE DOCUMENTATION MAZE; CONTENTS; INTRODUCTION; ABOUT THE AUTHORS; CHAPTER 1 UNDERSTANDING THE REGULATIONS; CHAPTER 2 PEOPLE, PROCESS, AND DOCUMENTATION; CHAPTER 3 PRINCIPLES OF DOCUMENT MANAGEMENT; CHAPTER 4 DECIDING TO GO ELECTRONIC AND FINDING A VENDOR; CHAPTER 5 MAKING THE TRANSITION FROM HYBRID TO VALIDATED E-SYSTEM; CHAPTER 6 PART 11 COMPLIANCE; CHAPTER 7 STANDARD OPERATING PROCEDURES; CHAPTER 8 NONCLINICAL RECORDS; CHAPTER 9 CLINICAL AND SUBMISSION RECORDS; CHAPTER 10 CONSISTENCY AND READABILITY IN DOCUMENTS; CHAPTER 11 MAINTAINING THE SYSTEM
327   $aCHAPTER 12 MAINTAINING INSPECTION READINESSCHAPTER 13 RESOURCES; APPENDIX; FEDERAL REGISTER; GUIDANCE FOR INDUSTRY; INDEX
330   $aThe accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment's notice. Written in a user-friendly Q&A style for quick reference, Managing the Doc
606   $aMedical records$xAutomation
606   $aMedical records$xData processing
615  0$aMedical records$xAutomation.
615  0$aMedical records$xData processing.
676   $a610.285
700   $aGough$b Janet$0878482
701   $aNettleton$b David$f1963-$0878483
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910140606303321
996   $aManaging the documentation maze$91961400
997   $aUNINA