Comply or Perish: Maintaining 21 CFR Part 11 Compliance
The biggest challenges of Life Sciences companies today are maintaining a robust product pipeline and reducing time to market while complying with an increasing and evolving multitude of Federal and international regulations. In this paper,
we discuss the particular requirements of rule 21 CFR Part 11 and describe how OpenText Regulated Documents built on OpenText Content Server – the leading collaborative knowledge management software from OpenText, enables Life
Sciences companies to comply with 21 CFR Part 11.