“I go checking out the reports, digging up the dirt. You get to meet all sorts, in this line of work”. Once famous lyrics from the Dire Straits song “Private Investigations”. When I was digging further into the oceans of lab data of a leading pharmaceutical company recently, as part of a comprehensive data integrity project, the words stuck with me. Contrary to the business Knopfler and friends referred to, we find our jobs a lot less depressing. In fact, we love it enough to dedicate this blog to it.
The project in question is in its final stage and comprises some 70 shop floor and lab systems. In order to make them all data integrity proof, not just for now but for years to come, we not only looked at the technology and procedures in use, but included documentation and configuration matters in the investigation as well. One of the priorities was to make sure that no record can be altered unnoticed. Any change to a record must be logged in an audit trail and reviewed regularly. Some data, such as date and time, can no longer be changed at all. In order to safeguard retrieval of data in the long run, all relevant data are now stored centrally and are backed-up automatically and at fixed intervals.
Documentation issues include determining and clearly defining the different roles that may be assigned to specific users. These specific roles must then be configured adequately and transparently to establish a segregation of duties and avoid conflicts of interest. To enhance transparency even more, user options are limited to an absolute minimum. This particularly applies to supervisors who are authorized to change parts of the production processes or even the recipe. Last but not least, we implemented some improvements in reporting. These were, in some cases, way to general in nature. Producing more specific reports allows for easier and faster retrieval and analysis of the modified records.
We are proud to say that our client passed the subsequent audits with flying colors. With inspectors becoming ever more literate in IT skills, this is a growing challenge. If your organization wants to stay out of ‘dire straits’, you know what to do. We are just a call or email away.