Process mapping involves a step by step walk through of existing (or proposed) activities considering inputs, outputs, decisions and possible sub processes on which the area of interest may be dependant. As such, process mapping is not only important for determining the scope of a LIMS project,
Overheard in the ABC Pharmaceuticals QC lab, "He understands the regulatory benefits of LIMS, but my boss also wants to see a tangible return on investment. Help!"
A major driver for implementing LIMS in regulated industries is the increasing focus of the MHRA, FDA & HPRA on the hot topic of data integrity. Failure to present a quality system that meets the requirements reflected in the ALCOA acronym ( data must be attributable, legible (permanent), contemporaneous, original and accurate) could lead to a loss of licence and result in a devastating impact on revenue.
GxP compliance in the pharmaceutical industry is a hot topic. With increasing numbers of drugs coming onto the worldwide market, it is important for pharmaceutical companies to make sure they operate within industry guidelines from development to production. Many companies use a Laboratory Information Management System - or LIMS - to facilitate compliance and ensure they have everything in place during regulatory body audits.