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Choosing your cloud provider – 3 things to consider

Posted by John Bennett on Oct 18, 2016 9:23:18 AM

I’ve been working with a Top 100 Telecoms organization on their cloud strategy so I was interested to see PwCs findings on the Top 25 Fastest growing cloud companies.* I thought it was a great overview of what can make a cloud partnership successful.

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Topics: QMS, ECM, PPM

6 Advantages of an EDMS for Medical Device Companies

Posted by Katherine Austin on Jul 22, 2013 3:49:00 PM

Top 6 Advantages of an Electronic Document Management System (EDMS) for Medical Device and Diagnostic Companies (Final - Part 6, Document Management Series)

As a company expands or a product moves from early R&D toward regulatory approval, the number of documents required seems to expand exponentially. This week’s post on the advantages of electronic document management systems (EDMS) versus paper is the sixth and final in a series based on an interview I did with Frances Kennedy, MBA, owner and principal consultant for P7 Management Consulting. These posts are focused around:

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Topics: ELN, Electronic Lab Notebook, Electronic Lab Notebook, Quality Management System, Regulatory, QMS, Enterprise Document Management, ECM, SOP, standard operating procedure

Where to Start? EDMS for Medical Device and Diagnostic Companies

Posted by Katherine Austin on May 21, 2013 7:00:00 AM

Where to Start? Electronic Document Management Systems (EDMS) for Medical Device and Diagnostic Companies (Part 5, Document Management Series)

As a company expands or a product moves from early R&D toward regulatory approval, the number of documents required seems to expand exponentially. What’s the best way to manage it all? And how do you decide where to start? This week’s post on deciding where to start in building an electronic document management system (EDMS) is the fifth in a series based on an interview I did with Frances Kennedy, MBA, owner and principal consultant for P7 Management Consulting. These posts are focused around:

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Topics: ELN, Diagnostics, QMS, electronic document management, edms, medical device

Top 6 Ways to Avoid EDMS Problems, for Medical Device and Diagnostic Companies

Posted by Katherine Austin on Apr 16, 2013 7:00:00 AM

Top 6 Ways to Avoid Problems When Implementing an EDMS, for Medical Device and Diagnostic Companies (Part 4, Document Management Series)

As a company expands or a product moves from early R&D toward regulatory approval, the number of documents required seems to expand exponentially. What’s the best way to manage it all? And where should you watch out for trouble? This week’s post on potential problems with implementing an electronic document management system (EDMS) is the fourth in a series based on an interview I did with Frances Kennedy, MBA, owner and principal consultant for P7 Management Consulting. These posts are focused around:

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Topics: ELN, Electronic Lab Notebook, Document Management, R&D, Quality Management System, Regulatory, QMS, Enterprise Content Management, Enterprise Document Management, FDA Regulations, Regulatory approval

Top 5 Essential Software Tools for Medical Device and Diagnostic Companies

Posted by Katherine Austin on Apr 4, 2013 7:00:00 AM

Top 5 Essential Software Tools for Medical Device and Diagnostic Companies (Part 3, Document Management Series)

As a company expands or a product moves from early R&D toward regulatory approval, the number of documents required seems to expand exponentially. What’s the best way to manage it all? And where’s the best place to start, if your company has limited resources? This week’s post on essential software tools is the third in a series on electronic document management, based on an interview I did with Frances Kennedy, MBA, owner and principal consultant for P7 Management Consulting. These issues are focused around:

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Topics: Electronic Lab Notebook, R&D, Diagnostics, Quality Management System, Regulatory, QMS, Enterprise Content Management, Enterprise Document Management, FDA Regulations, Regulatory approval, Medical Devices, In Vitro Diagnostics, CE Mark

Best Practices for Choosing an EDMS for Medical Device and Diagnostic Companies

Posted by Katherine Austin on Apr 2, 2013 7:00:00 AM

Best Practices for Choosing an Electronic Document Management System, or EDMS, for Medical Device and Diagnostic Companies (Part 2, Document Management Series)

Beginning with my last post and continuing for the next few weeks, I’ll be discussing a number of document-management issues with Frances Kennedy, MBA, owner and principal consultant for P7 Management Consulting. These issue are focused around:

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Topics: ELN, Electronic Lab Notebook, Document Management, R&D, Diagnostics, Quality Management System, QMS, Enterprise Content Management, Enterprise Document Management, Content Server, eNovator, Medical Devices, In Vitro Diagnostics, ECM, Records Management

Glossary of Regulatory Terms - Diagnostics and Medical Devices

Posted by Katherine Austin on Feb 21, 2013 4:03:00 PM


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Topics: ELN, Electronic Lab Notebook, Diagnostics, Quality Management System, QMS, FDA Regulations, Medical Devices, In Vitro Diagnostics, FDA

Companion Diagnostics: Meet the FDA

Posted by Katherine Austin on Feb 12, 2013 7:00:00 AM

Companion diagnostic: An in vitro diagnostic test or device that provides information essential for the safe and effective use of a corresponding therapeutic product (e.g., a drug).

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Topics: Electronic Lab Notebook, Diagnostics, Quality Management System, Regulatory, QMS, FDA Regulations, FDA

What does FDA Section 522 mean for Medical Device Companies?

Posted by Katherine Austin on Jan 21, 2013 7:00:00 AM

“Section 522”: FDA Can Order Extra Studies from Medical-Device Companies in Special Cases 

Medical devices can cause adverse effects that weren’t anticipated either by the manufacturers or by regulatory agencies. High-profile cases have included metal-on-metal hip replacements and transvaginal surgical mesh. According to the Government Accountability Office, there were about 3,500 medical device recalls from 2005 to 2009. Many of these were ranked as “Class I” recalls—in other words, they involved a defect serious enough to create a "reasonable probability of adverse health consequences or death."

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Topics: ELN, Electronic Lab Notebook, Quality Management System, Regulatory, QMS, FDA Regulations, Content Server, eNovator, Medical Devices, In Vitro Diagnostics, FDA, opentext, CE Mark

Safer Medical Devices and Diagnostics: New FDA Regulations

Posted by Katherine Austin on Jan 8, 2013 1:52:00 PM

Safer Medical Devices and Diagnostics: New FDA Regulations for Post-Market Tracking

Introduction

Welcome to the Modern Age of Medicine. New, smaller, faster, and more complex diagnostic kits and medical devices are coming to market almost daily, driving an industry now worth over $100 billion a year. Given how much the landscape has changed, combined with the increased complexity of these products and concerns raised by several high-profile recalls—the FDA has recognized that it’s time to update the laws that regulate medical devices and in vitro diagnostics.

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Topics: ELN, Electronic Lab Notebook, Document Management, Diagnostics, Quality Management System, QMS, Medical Devices, ECM

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