CHAPTER 12: The Hybrid System Problem Check Access

Hybrid systems are computerised systems that generate electronic records with signed paper printouts. They are very common in regulated analytical laboratories as suppliers do not design adequate systems and users do not press for better solutions. Their use presents several problems such as traditional reliance on the paper printouts as the raw data, most hybrid systems are standalone workstations unconnected to a network, allowing deletion of records and time travelling as well as the difficulty in synchronising the electronic and paper records throughout the record retention period. Even systems that can work electronically are often operated in a hybrid mode as laboratories are very conservative and unwilling to change working practices. In short, hybrid systems are THE WORST possible solution for ensuring data integrity in a regulated laboratory. The simple answer is to replace them with electronic solutions wherever possible but this requires suppliers to deliver better applications for controlling analytical instruments. As the market is driven by user requests will users of these systems see the light and demand changes to the architecture and way hybrid systems work?