CHAPTER 13: Get Rid of Paper: Why Electronic Processes are Better for Data Integrity Check Access

Following on from the problems with hybrid systems that we discussed in Chapter 12, I now want to focus on how to resolve these problems by their replacement. In Chapter 1, we discussed that data integrity is a bigger programme of work compared with the Year 2000 and 21 CFR 11 remediation projects combined. The issue with these two earlier projects is that typically there was little or no business benefit obtained when systems were remediated. In this chapter, we consider the longer-term solutions of systems and processes to deliver business improvement and benefits for the time and money spent. This is essentially a move away from paper records to automated laboratory processes designed to ensure data integrity with transparent data capture and processing and with minimal manual data input from laboratory staff. This approach could be viewed as a second attempt to get the intent of 21 CFR 11 regulations right. Not all processes can move to electronic working either because there is not an application available or it is not cost effective to do so. However, most work within a regulated analytical laboratory can be automated – are organisations willing to invest and make their laboratories more efficient and effective?