Data integrity in pharmaceutical and medical devices regulation operations : best practices guide to electronic records compliance / Orlando Lopez.
نوع المادة : نصاللغة: الإنجليزية الناشر:Boca Raton : CRC Press/Taylor & Francis, 2017وصف:xxii, 372 pages : illustrations ; 26 cmنوع المحتوى:- text
- unmediated
- volume
- 9781498773249 (hardback : alk. paper)
- R858 .L66 2017
نوع المادة | المكتبة الحالية | رقم الطلب | رقم النسخة | حالة | تاريخ الإستحقاق | الباركود | |
---|---|---|---|---|---|---|---|
كتاب | UAE Federation Library | مكتبة اتحاد الإمارات General Collection | المجموعات العامة | R858 .L66 2017 (إستعراض الرف(يفتح أدناه)) | C.1 | Library Use Only | داخل المكتبة فقط | 30020000118767 | ||
كتاب | UAE Federation Library | مكتبة اتحاد الإمارات General Collection | المجموعات العامة | R858 .L66 2017 (إستعراض الرف(يفتح أدناه)) | C.2 | المتاح | 30020000118766 |
Includes bibliographical references and index.
Inspection trends -- Electronic records life cycle -- Electronic records related definitions -- Electronic records handling : 21 CFR part 211 -- Electronic records handling : EMA annex 11 -- Relevant worldwide GMP regulations and guidelines -- Trustworthy computer systems -- MHRA guidance -- Electronic records governance -- Procedural controls for handling E-records -- Electronic record controls : supporting processes -- Electronic records controls : records retained by computer storage -- Electronic record controls : during processing -- Electronic record controls : while in transit -- Electronic records and contract manufacturers -- Electronic records and Cloud computing -- Self-inspections -- Electronic records remediation project.