Cradle to Grave LIMS in an FDA-regulated Industry

摘要

The LIMS benefits have persuaded many pharmaceutical companies to abandon their paper notebooks and Excel spreadsheets and start evaluating LIMS applications. Some have had great successes while others have failed. Successful LIMS implementation is a doable task, but it needs discipline, accountability, responsibility, leadership and control. It is important that the plan is set forth clearly and all its components are well-communicated to the staff. The staff needs comprehensive training, or it might be necessary to bring in consultants or to hire experienced LIMS staff. It is easy to forget that our paper system of information management has been around for 6,000 years, while our software system has been around for only 25 years. Additional thought and control need to be in place to increase the odds of success for LIMS.