Author: Marcus McNeely

  • RP-6: Calibration Quality Systems for the Healthcare Industry

    As many of you know, I’ve long been involved with NCSL International (NCSLI) in a number of capacities; one of which has been the upkeep of one of the organization’s guidance documents, Recommended Practice – 6 (RP-6). My first activity with the document was on the third edition in 2008. Most recently, I have played […]

  • Measuring-up my Metrology Foundation

    I find that as I continue on in my career, I increasingly reflect on the foundations. I think about the great mentorship that’s fostered my body of knowledge, the challenges I’ve faced and the rewards for my enthusiasm to continue to learn and develop myself. One of the strongest foundations is NCSLI (which is a […]

  • Battling the Mandate: ERP Module versus EAM / CMMS Software

    In our previous blog, Randy highlighted the trends driving management to mandate the use of ERP modules for maintenance and calibration. At the root of all of the trends is management’s need to gain a deeper perspective of the organization. In order to achieve this, corporations are looking to leverage an Enterprise Resource Planning system […]

  • Contract Laboratory Qualification

    I’m happy to have the chance to update the site with another editorial, and amazingly, it still takes little time to think of another topic to pencil in for posting. There are so many to choose from. Finding the time to write them can be another story, but here I am. I’m on yet another […]

  • Pipettes in a Regulated Environment

    For me, all of this started not with pipettes, but with automatic burettes. We were in fact not allowed to use pipettes in that laboratory, in favor of class ‘A’ volumetric glassware. The sample preparation deliveries supported HPLC test methods, and I can’t say I blamed the scientific director for disallowing their use, due to […]

  • Bound by Overly Stringent Process Tolerences in Calibration Management

    Welcome, Metrologists, QA Personnel, Regulated Personnel and otherwise, Where to start? This being the first of a series of editorials on life in the field of calibration in regulated environments; I ponder the genre of materials that I could contribute, should contribute, in addition to things I would like to blog, but probably shouldn’t… What […]

  • Harmonization of Calibration, Maintenance and Validation

    Have you ever seen a pharmaceutical facilities department with four heads?  It’s the stuff of fireplace folklore. Long, long ago, swamps once untouched by man thrived with these beasts, until such time as their reclamation, making way for the pharmaceutical and biotech companies now in their place. This forever displaced the beings long indigenous to […]

  • MSC Conference – Global Economic Challenges Drive Operation Change in Metrology

    Greetings to all my colleagues once again. I have a few ‘Metrological Retreats’ every year, where I find myself with more old friends than I can count. I can also say that I never leave without a sizeable amount of new knowledge to take away, and if you haven’t had a chance to attend an […]