In our latest blog we explained how Petrik Cuijpers executed a comprehensive data integrity project for an important Vivenics customer. At the same time, just a few doors down the hall, one of his Vivenics colleagues, Rob van Gammeren, was going through his own ocean of data for another one. Whereas Petrik focused on aligning already existing procedures with new data integrity regulations, Rob was following a more system-driven approach.
Rob, who used to work for renowned chemical organizations such as Akzo Nobel, started working for Vivenics early 2016. With extensive ICT project management experience in data processing and data visualization at a pharmaceutical company, the project was just the job for Rob. Says Rob: “The assignment started with assessing all automated lab systems with regard to data integrity using a comprehensive checklist covering all data integrity requirements. Based on the outcome, I drew up action plans for each individual system of what needed to be addressed in order to make each system 100% data integrity proof. As in recent years vendors of lab systems have started to improve 21 CFR Part 11, EU Annex 11 and data integrity compliance of their software, this meant that for several systems hardware and software upgrades were the way to go to. Alternatively a protective software shell and/or procedural solutions are implemented to further strengthen data integrity performance.”
New way of working
“Building on an already well-developed DI culture, we also ‘educated’ users on how to further improve dealing with raw, electronic data for DI purposes. As some lab staff were still used to working with paper records, execution of the data integrity remediation program also implied changes in their way of working, for instance (if possible remotely) reviewing electronic data, including audit trails, directly on the system. Obviously, change management skills had to be applied to overcome some understandable resistance. In the meantime the program is well on its way for completion.”
“Basically, the approach I adopted is more system-driven than the one Petrik follows which is driven by procedures. The system-driven approach may be more suitable in an environment where DI gaps are mostly system-related and investments in new equipment and software is being considered first. As a result, the required updating of procedures will follow automatically. The approach to start with aligning procedures may be the preferred option in an area where most of the DI gaps are resulting from the procedural corner. DI proving the procedures may require to upgrade some of the systems as a result.
Either approach or a combination of the two may work for organizations, depending on their individual situation and degree of data integrity compliance.”