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.
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:
Topics: ELN, Electronic Lab Notebook, Quality Management System, Regulatory, QMS, Enterprise Document Management, ECM, SOP, standard operating procedure
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:
Topics: ELN, Diagnostics, QMS, electronic document management, edms, medical device
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:
Topics: ELN, Electronic Lab Notebook, Document Management, R&D, Quality Management System, Regulatory, QMS, Enterprise Content Management, Enterprise Document Management, FDA Regulations, Regulatory approval
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:
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
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:
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
Topics: ELN, Electronic Lab Notebook, Diagnostics, Quality Management System, QMS, FDA Regulations, Medical Devices, In Vitro Diagnostics, FDA
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).
Topics: Electronic Lab Notebook, Diagnostics, Quality Management System, Regulatory, QMS, FDA Regulations, FDA
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."
Topics: ELN, Electronic Lab Notebook, Quality Management System, Regulatory, QMS, FDA Regulations, Content Server, eNovator, Medical Devices, In Vitro Diagnostics, FDA, opentext, CE Mark
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.
Topics: ELN, Electronic Lab Notebook, Document Management, Diagnostics, Quality Management System, QMS, Medical Devices, ECM
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