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 would...
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 a...
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 like...
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 a...
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 effective...
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 how...
ColumbiaSoft is engaged in developing document management solutions for Fortune 500 companies
Im not sure what surprised me most in this video by CBS News: Copy Machines, a Security Risk? That so many people are not aware that MFP's (multi-function printers) keep a copy of what you copy; Or, the fact that someone paid just a few hundred dollars for a copier that looks similar to a white elephant we lease for...
Part 5 - A Viable Solution Realizing the benefits of effectively organizing and indexing documents is only the tip of the iceberg when you consider the possibilities provided by a fully-featured document management system. I have witnessed how companies have successfully refocused their employees from performing unproductive roles like constantly searching lost documents into roles that directly derive revenue for the...
In these uncertain economic times, most companies are faced with the challenge of how to maximize returns on tighter margins. It’s a do-more-with-less strategy that requires business operations be optimized now to meet current economic realities. One area to consider for improving the bottom line is to look at how information is managed in the organization. This includes all the content,...
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