Data integrity and compliance : a primer for medical product manufacturers

Saved in:
Bibliographic Details
Main Author Rodríguez Pérez, José, 1961- (Author)
Format Electronic eBook
LanguageEnglish
Published Milwaukee, Wisconsin : ASQ Quality Press, [2019]
Subjects
Drugs > Standards > United States.
Computer security > Standards > United States.
Pharmaceutical industry > Standards > United States.
Quality control.
elektronické knihy
electronic books
Online AccessFull text
ISBN9781951058470
195105847X
9780873899871
0873899873
Physical Description1 online resource (xx, 253 pages)

Cover

Table of Contents:
  • 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.

Similar Items