Maintaining a Calibration Management Software System in a Regulated Environment

by Walter Nowocin

Maintaining a Calibration Management Software System is a critical process for a calibration laboratory, especially in a bio-medical regulated environment. However, there are few examples or documents that explain this process from a user’s perspective. The objective of this paper is to explain the software system maintenance process, provide examples of the documentation used, and to pass along lessons that were learned. The following topics will be discussed: Maintenance Process Overview, Change Control, Configuration Management, and System Operation. The Maintenance Process is the longest running phase of the System Development Life Cycle (SDLC) and therefore requires careful planning, design, and documented procedures. It is the intent of this paper to help users more effectively maintain their Calibration Management Software System.

Read the Full Article (PDF)