Planning and Remediation of Systems for Part 11 Compliance By Stephen Robert Goldman In order to perform remediation planning, it is best to have a plan that details what is to be done, who is to do it and the time frames necessary to affect a…

Paperless at Schering-Plough Article written by: Editor in Chief Tom von Gunden, Pharmaceutical Online Schering-Plough has made the transition to a paperless system for managing instrument calibration records. Frankly, I applaud this initiative….

The Evolution of Paperless Calibration Management Software It’s been Evolution, Not Revolution in the calibration software field as manufacturers continue a never-ending quest for greater functionality. The environment in which many…

Guidance for Industry(1) Part 11, Electronic Records; Electronic Signatures — Scope and Application DRAFT GUIDANCE – This guidance is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be…

Guidance for Industry Computerized Systems Used in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC) This guidance represents the Food and Drug Administration’s…

Compliant Paperless Calibration for Pharmaceutical Manufacturing Kevin J. Daubert Facilities Engineer & Bernard J. Williams Prime Technologies, Inc The calibration of instrumentation, devices and equipment, along with many other functions…

PA Compliant Calibration Program By Pharmaceutical Technical Services (PTS) The terms used in this paper are examples and are used throughout this document as points of reference. CHARACTERIZATION AND CLASSIFICATION All…

Calibration Management in the ISO/IEC 17025-Accredited Facility The right software can simplify and strengthen your quality practices. by Bernard Williams Know & Go Calibration is not just another maintenance activity; it’s more…