Quality

Video tutorials on how to manage procedures electronically

Managing procedures can be a real challenge. This is especially true if your program is paper-based. But even if your procedures are electronic, if you don’t have the necessary document control practices in place, you are probably still challenged with keeping the correct versions up to date and chasing down approvals. ColumbiaSoft Solutions Engineer Dave Howell recently covered the subject [...]

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Record Attendance at FMMC Symposium

On May 6 and 7 I attended the Florida Medical Manufacturers Consortium (FMMC) symposium.   This year marked their 10th anniversary.   John Ray, Executive Director of FMMC told me membership had doubled in the past two years.  So it was no surprise attendance was a record.   The mission of FMMC is to promote networking, industry knowledge & expertise and advocacy [...]

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Transitioning to the eTMF: Part 2

A couple of weeks ago, I discussed the TMF Reference Model, how it came about, why it’s important. The level of organization is thorough and in depth. As someone who arranges the contents of their closet by color, sleeve length, and fabric weight, I find this extremely practical and spiritually fulfilling. Not kidding. That was all background, so that you [...]

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FMMC’s annual Florida Medical Device Symposium

The FMMC’s annual Florida Medical Device Symposium is just around the corner! I am attending the Florida Medical Device Symposium May 6th-7th in St. Petersburg.  We will be co-exhibiting with our partner in the Tampa area, Prism Plus Consulting.  This will be our third year as an exhibitor with Mary McCoy, President of Prism Plus Consulting.  FMMC has put together [...]

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Transitioning to the eTMF

Do you have a regulatory soul? A VP of Regulation & Compliance told me that I did, a few months ago, when I collaborated with them to build a repeatable folder structure that aligns with the updated eTMF Reference Model guidelines that the DIA released last year. Honestly, though, if you’re going to have valuable files that document a sensitive procedure [...]

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Medical device manufacturer Anspach saves with document control software

The Anspach Effort, a medical device manufacturer of high-speed power tools used in neurosurgery, spinal, and ENT surgery, recently deployed document control software and it turns out they are already seeing the value: A marked improvement in their ability to manage quality, engineering and manufacturing records while at the same time reducing costs. The gains were clearly demonstrated during [...]

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Quality Superhero goes to Bio International to talk Document Control

Truth and accuracy in document control is the message that ColumbiaSoft’s Quality Superhero will be bringing to world’s largest gathering of biotechnology leaders in Washington D.C. at the Bio International conference. Although he’s more a concept than a real caped comic-book character, Quality Superhero does illustrate ways firms in the highly-regulated biotech and pharmaceutical industries can improve quality management with [...]

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Document control reduces risk.

Automated workflows and precise versioning replace paper and manual processes in document control software. Everything from ECO’s, SOP’s, CAPA’s, NCR’s, Work Instructions… basically any process can be automated with workflows. Even better is the fact that detailed audit logs are captured, and it’s possible to reference version histories with ECO numbers. This short 2-minute video is a quick overview of [...]

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