Clinical Quality Management System
Even 20 years after the issuing of the ICH GCP Guidelines (ICH E6), the principles of GCP are still sound, and little can be criticized about them. The updates of the Guidelines and especially its Addendum [ICH E6(R2)] that in Europe became effective in 2017 have not fundamentally changed the content of this Guideline but introduced technology and approaches that were unknown when the GCP Guideline got issued for the first time. Twenty years ago clinical development was largely a paper-based process, and the Internet and even more so the Cloud were technology and tools only known to a few techies.
References and Further Reading
- Deming EW (1966) Some theory of sampling. Dover Publications, Mineola NY, USAGoogle Scholar
- Imai M (1986) Kaizen: the key to Japanese competitive success. McGraw Hill, New York, USAGoogle Scholar
- Lunau S et al (2006) Six sigma + lean toolset. Springer Verlag, Heidelberg, GermanyGoogle Scholar
- Spear SJ (2009) The high velocity edge. McGraw Hill, New York, USAGoogle Scholar