I have been around long enough to remember (just about) before computers and for many years was highly suspicious of computerized systems. Today I have undergone a 180 degree turn and firmly believe that ONLY FULLY computerized systems – carefully designed, implemented, validated and with a program for maintenance and ongoing monitoring, can provide the answers we are looking for regarding data integrity.
As an example: weight printouts. I always thought those were the ultimate answer to data integrity. You weigh, you have a printout, you stick it in the notebook and sign – half on, half on the page so you would see if it was removed. A client pointed out that the analyst can quite easily change the date and time on the balance so that if they don’t like the weight or the result is “just a little out of specification, ” they can make a new printout with a different weight. Now that might seem like something really deceitful – but if you need to get out to pick up the little kid from nursery and you are really close to the “right” result – in a company where the opportunity exists, you might make a bad choice. However, in a company with a LIMs system where the balance feeds directly into an electronic notebook, there is no opportunity to do this.
There is a Bible commandment saying to “not to place a stumbling block before the blind” – computerized systems can prevent the opportunities. Although as an industry we are not very proactive in our computerized systems. When I benchmark on electronic notebooks in QC labs – I rarely get hands raised at all in a group of 2-300 people. This makes it abundantly clear that the pharma industry still has a way to go.