.

0 (hodnocen0 x )

EB

ONLINE

Milwaukee, Wisconsin : ASQ Quality Press, 2019

1 online resource (278 pages) : illustrations

ISBN 9781951058470 (e-book)

ISBN 9780873899871

Print version: Rodriguez Perez, Jose, 1961- Data integrity and compliance : a primer for medical product manufacturers. Milwaukee, Wisconsin : ASQ Quality Press, 2019 278 pages ISBN 9780873899871

Includes bibliographical references and index

Data integrity and good documentation practices -- ALCOA : expectations and examples -- Regulatory expectations -- Regulatory enforcement -- Data life-cycle -- Integrating data integrity into the quality system -- Clinical data integrity -- Preventing data integrity problems -- Data governance and data integrity audit -- Good documentation practices and data integrity training -- Investigating and disclosing data integrity issues -- Data integrity for outsourced activities -- Maintaining integrity of electronic data.

002007627

full

(Au-PeEL)EBL6262214

(MiAaPQ)EBC6262214

(OCoLC)1159982754