Data integrity in pharmaceutical and medical devices regulation operations : best practices guide to electronic records compliance / Orlando Lopez.

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.