LEADER 03125oam 2200505I 450 001 9910149367503321 005 20240501153410.0 010 $a1-315-36709-2 010 $a1-315-34997-3 010 $a1-4987-7326-5 024 7 $a10.1201/9781315367095 035 $a(CKB)3710000000933747 035 $a(MiAaPQ)EBC4732239 035 $a(OCoLC)962305511 035 $a(EXLCZ)993710000000933747 100 $a20180420d20172017 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 10$aData integrity in pharmaceutical and medical devices regulation operations $ebest practices guide to electronic records compliance /$fOrlando Lopez 205 $a1st ed. 210 1$aBoca Raton :$cCRC Press/Taylor & Francis,$d[2017]. 210 4$dİ2017 215 $a1 online resource (395 pages) $cillustrations, tables 225 0 $aProductivity Press Book 311 08$a1-4987-7324-9 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $a1. Introduction -- 2. Inspection trends -- 3. Electronic records life cycle -- 4. Electronic records related definitions -- 5. Electronic records handling : 21 CFR part 211 -- 6. Electronic records handling : EMA annex 11 -- 7. Relevant worldwide GMP regulations and guidelines -- 8. Trustworthy computer systems -- 9. MHRA guidance -- 10. Electronic records governance -- 11. Procedural controls for handling E-records -- 12. Electronic record controls : supporting processes -- 13. Electronic records controls : records retained by computer storage -- 14. Electronic record controls : during processing -- 15. Electronic record controls : while in transit -- 16. Electronic records and contract manufacturers -- 17. Electronic records and Cloud computing -- 18. Self-inspections -- 19. Electronic records remediation project -- 20. Summary. 330 $aData integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years' experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved. 606 $aMedical informatics 606 $aPharmacy informatics 606 $aMedical instruments and apparatus industry$xQuality control 615 0$aMedical informatics. 615 0$aPharmacy informatics. 615 0$aMedical instruments and apparatus industry$xQuality control. 676 $a610.285 700 $aLopez$b Orlando$0886634 801 0$bFlBoTFG 801 1$bFlBoTFG 906 $aBOOK 912 $a9910149367503321 996 $aData integrity in pharmaceutical and medical devices regulation operations$91979884 997 $aUNINA