Many organizations, especially those involved in manufacturing, engineering, and production, must develop and adhere to strict standards to ensure the output of what they produce meets quality and safety expectations. Quality control guidelines take a considerable amount of forethought and planning. It’s an ongoing process that requires continual evaluation and adjustment to ensure processes run smoothly and output expectations are...
I've been a quality professional since 1981, and during my career I’ve held positions as a lead auditor, quality manager, director of quality, an independent ISO Consultant and a registrar auditor for ISO 9001, AS 9100, ISO 14000 and ISO 13485. As an auditor, 80% of audit findings were document control issues. That’s why it’s so important that your method for...
Over a million companies are ISO-9001 certified. ISO-9001 is the worldwide standard for maintaining a Quality Management System (QMS). Document control software helps organizations meet these standards with greater ease and effectiveness. Managing the documentation for ISO-9001 compliance is no small undertaking. In the very early days of ISO-9001, document control was accomplished with a typewriter and a three-ring binder. Today...
When it comes to maintaining compliance with standards and regulations, a comprehensive document control software solution can be extremely valuable. When compared to paper-based solutions, or manual file management in a shared server environment, document control software has extreme advantages. It has built in intelligence that not only ensures files are managed properly by the appropriate users, but it also...
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 of...
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 for...
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...
