Calibration Services Keep Your Equipment Working Strong And Reliably The importance of calibration service cannot be undermined when it comes to bringing your machines and equipment back to their original working form. This process helps you align your machines with the original manufacturer’s specifications. By carrying out regular calibration checks, you can make sure that [...]
Uncertain About Your Calibration Uncertainty? One of the most commonly debated issues among accredited calibration professionals and often least understood by sensor users is the concept of measurement uncertainties. To the novice user, the manufacturer’s stated calibration is simply accepted as gospel. However, a closer inspection of the calibration certificate reveals that the calibration lab [...]
Calibration in the Cleanroom The importance of particle counting, testing of HEPA filters, etc. is widely known, but how important is the calibration of the associated instrumentation within a cleanroom environment? One of the most prevalent devices in a cleanroom environment is the Magnehelic gauge. These are used as an easy to read indicator for [...]
Understanding Flowmeter Performance and Calibration The importance of understanding your flow metering application and undertaking careful monitoring and maintenance of your flow meter system will ensure your flow readings continue to give repeatable and accurate readings. Having received thousands of flow meters for routine re-calibration, it is often the end users’ lack of knowledge of [...]
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 speedy resolution. Create a project plan in both narrative [...]
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. Given the pharmaceutical manufacturing industry’s relatively cautious approach to adopting electronic records-keeping systems, Schering-Plough’s decision to dispense with paper in the critical [...]
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 manufacturing companies operate is one that is very exacting and often subject to scrutiny by internal and corporate auditors, or by regulatory agencies. There [...]
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 submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit [...]
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 (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does [...]
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 performed during the manufacture of finished pharmaceutical products, are mandated within the FDA’s Code of Federal Regulations Part 211 (Current Good Manufacturing Practice For Finished [...]