e-Compliance Requirements Initiative
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:
Searching for culprits is not today's goal.
Furthermore, the aim is to help the regulated pharmaceutical industry and its suppliers to implement regulatory requirements, including e-Compliance requirements, consistently and efficiently.
Purpose and objectives
The purpose of the e-Compliance Requirements Initiative – eCRI – is to propose a discussion and working platform to enable regulatory knowledge sharing between industry and suppliers.
The main objective is to build task forces dedicated to the elaboration of different sets of e-Compliance requirements (URS) for the various types of system and solution.
Compliance requirement mythos
A solution will never efficiently implement regulatory e-Compliance requirements if the related URS states, for instance:
> Regulated user duty
It is regulated user duty to spell out requirements in a way requirements are understandable, usable, testable, and complete.
> Supplier duty
It is supplier duty to take over such requirements into the design of the developed solutions.
It is supplier duty to be able to challenge and to improve these compliance requirements for achieving a reliable and efficient implementation.
It is supplier duty to educate and to train its personnel in order to improve implementation expertise and excellence.
Proposed approach – e-Compliance by Design
The e-Compliance Requirements Initiative proposes to build task forces for elaborating the e-Compliance relevant parts of URS for a specific system type, e.g.:
In order to enable concurrent work, the relevant e-Compliance topics will be assigned to different task forces with the mission to cover comprehensively the specific topic; e.g.:
The primarily focus will be put on the technical implementation (features) of Annex 11 to European GMP, 21 CFR 11, and data integrity (ALCOA+).
How to ...
Every volunteer is welcome.
The main objective of the Initiative is to bring together:
The volunteers could be from:
The work will consist of:
The task forces will work based on phone conferences and e-mails, as well as, if appropriate, face-to-face.
The documents will be written in English and they will be freely available (public domain).
If you are interested to participate, you should send an e-mail to: firstname.lastname@example.org.
Because e-Compliance represents a real added-value and efficiency improvement!