This column revisits the topic of raw data and electronic records for a chromatography data system (CDS) in light of recent
updates in regulations and guidance issued by regulatory agencies and industry bodies. We look at the ways to define what
raw data are for a CDS and pose the question: Is it still possible to define paper records as chromatographic raw data?
In this Questions of Quality column I want to return to a topic that I have discussed twice before in the past few years: What are the raw data and/or
electronic records for a chromatography data system (CDS)? In December 1996 I published the first Questions of Quality on raw data (1) and, with the timing that snatched defeat out of the jaws of victory, I was in print before the final rule
on electronic records and electronic signatures was issued by the FDA in March 1997 (2). Therefore in 2000, I returned to
the subject of raw data in light of industry and my experience with Part 11 to discuss and define the scope of electronic
records that you could have with a CDS (3). More recently, in 2011, there was the revision of EU GMP Annex 11 on computerized
systems (4) and Chapter 4 on documentation (5) that I reviewed in this column last year (6). Although the Questions of Quality column focused on Annex 11, there were significant changes to Chapter 4 on documentation that I want to focus on in this
column. This is the new requirement to define raw data for systems involved in making quality decisions (5). As a CDS will
be used to release raw materials, finished products and stability testing, it will be involved in making quality decisions
and the raw data needs to be defined. Therefore what should we do for a CDS? Has anything changed since I wrote the first
article on this topic over fifteen years ago?
To give you an idea of what we will be discussing I have presented the regulations, regulatory guidance and industry guidance
documents to be discussed in Figure 1. First we'll look back and I'll give you a summary of the points from the Questions of Quality columns from 1996 and 2000 (1, 3), the latter article being greatly influenced by the publication of 21 CFR 11 regulations
(2). Then we'll begin by looking at the FDA Guidance on Part 11 Scope and Application published in 2003 (7), which was expanded
with the FDA interpretation published in 2004 (8) for electronic versus paper records for a CDS.
Next, we will look in more detail at the specific EU GMP requirements for raw data from the new version of Chapter 4 on documentation
(5). However, as Chapter 4 does not give a definition of raw data, we will look at the definitions in the US GLP regulations
(9) and a Swiss GLP Guidance (10). Finally, we'll end with a look at what is said in the FDA's Compliance Programme Guide 7346.832 on Pre-Approval Inspections (11) and the second edition of the GAMP
Good Practice Guide: RiskBased Approach to GxP Compliant Laboratory Computerized Systems (12).
Figure 1: Outline of this month’s column on raw data.