TABLE OF CONTENTS This section is only applicable for the initial validation of a new CDS system. However, as you will be using a new system for up to 10 15 years, you will need to be confident that the selected system meets your requirements and the CDS will do the job you ask of it.
PIC/S Guide Section 9.331:
The URS, although independent of the supplier should be understood and agreed by both user and supplier.
This has a link to a footnote at the bottom of the page.
Note: This is straightforward for a bespoke system. However, for marketed proprietary systems or configurable packages then it is for prospective users, integrators and suppliers to discuss and review proposed user requirements, versus package functionality. It is essential to determine the degree of fit and then control any necessary configuration work, modification, coding, testing and validation requirements in line with this guidance.
Section 11.3: Supplier and developer reputations and trading histories for the software product provide some guidance to the level of reliability that may be assigned to the product supplied.
The pharmaceutical regulated user therefore should have in place procedures and records that indicated how and on what basis suppliers were selected.
Does a commercial CDS match your existing or proposed ways of working? If not will you make any compromises either in the way that you will work or the way the new CDS will be used? The rationale for...
