Case Study
ACHIEVING DATA INTEGRITY THROUGH STARLIMS
ACHIEVING DATA INTEGRITY THROUGH STARLIMS STANDALONE SCIENTIFIC DATA MANAGEMENT SYSTEM STARLIMS is now offering a standalone version of STARLIMS Scientific Data Management System (SDMS) to help clients achieve compliance with the data integrity expectations of the Food and Drug Administration (FDA) as well as other regulatory authorities. The acronym “ALCOA”, largely attributed to the FDA and later expanded to ALCOA+ by the European Medicines Agency, helps us remember the key concepts relevant to data integrity. The requirements are that data be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available 1 . These concepts must not only be applied to a paper environment but also the electronic world. Common data integrity issues include