Description: eCRI - e-Compliance Requirements Initiative - ecri.tech
gxp (34) 21 cfr part 11 (23) e-compliance (2) annex 11 (2) 21cfr11 (2) 21 cfr 11 (1)
Although e-Compliance and data integrity requirements have been defined decades ago, the regulated pharmaceutical industry is still struggling with the accurate implementation of such requirements in the daily business activities.
There are several causes for this inappropriate situation: Difficulties for the regulated industry – pharmaceutical manufacturers – to spell out in the solution/system specifications (URS) e-compliance requirements accurately and consistently Inability for the solution providers – equipment manufacturers, software editors ... – to understand and interpret such e-compliance requirements and to take those into account by designing software solutions.
Searching for culprits is not today's goal.