TABLE OF CONTENTS What are the electronic records generated and maintained in a chromatography data systems? Why do we need to change our approach to managing electronic records compared with paper ones? The discussion in this chapter focuses on the definition of electronic records produced by a CDS and this is influenced by the way you use the system as defined in your URS.
It is debatable if this chapter should be in the section before the operational release of the system or after. I have chosen to place it in the operational section as the way the system will be used will usually change over time and therefore the electronic records generated by the system will reflect this change.
Electronic records definition:
any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system17
Part 2 Definition of Part 11 Records18:
Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format . We recommend that you determine, based on the predicate rules, whether specific records are part 11 records. We recommend that you document such decisions.
Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record...
