Per a discussion on the Apple Support Communities there is a bug within iOS 6 that may cause unexpected behavior when declining a meeting request from your device, whether it be iPad, iPhone or iPod. Upon declining the meeting request you may actually send a cancellation to all invite recipients. If you really don't want the meeting to happen, this is an awesome way to override the organizers wishes. However, given that this is happening within your Corporate messaging system, please heed the following recommendation.
For now, use your Corporate workstation to accept or decline meeting invitations.
Having this issue? Let me know.
In mid-July, the FDA released a draft guidance document to assist manufacturers with varying questions. The Draft Guidance on Mobile Medical Applications limits the FDAs focus on mobile applications to those that have either traditionally been considered medical devices or those that affect the performance/functionality of current regulated medical devices. It is highly suggested that evaluations be performed on mobile applications to determine if they fall into the medical application category. The FDA has defined a Mobile Medical Application as those meeting the following criteria:
• Meets the definition of a device as defined in Section 201(h) of the Food Drug & Cosmetic Act. In other words the device is:
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
• Is used as an accessory to a regulated medical device
• Transforms a mobile platform into a regulated medical device
The FDA believes that mobile medical applications that meet the above criteria pose a similar potential risk to public health as currently regulated devices, if they fail to function as intended. Given this, the FDA will apply its regulatory oversight to ensure that mobile medical applications do not adversely affect public health.
Listed below are examples of mobile medical application functions that have already been deemed by the FDA as qualifying as a medical device. Those functions include:
• Viewing of medical images to perform an analysis or process for diagnosis
• Analyzing, assessing or interpreting electrocardiogram or electroencephalogram data
• Input of a patient-specific information along with reference material to automatically diagnose a disease or condition
Mobile devices will continue to evolve and advance health care well into the future. Developers of mobile applications who use a sound quality management system to create the applications will fare much better under FDA scrutiny than those that don’t.
Do you agree or disagree? Let me know!
Interphase Systems will be exhibiting at the 2011 PDA/FDA Joint Regulatory Conference on September 19-20, at the Renaissance Hotel in Washington, D.C.
The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes. Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance. You won’t find this level of direct information exchange with FDA at any other conference!
Interphase Systems provides cost effective software products and solutions to meet your regulatory needs. Our risk based validations approach saves you time and money. Showcased products include Ready-CAPA (Corrective and Preventative Action software to track issues, observations, incidents and improvements to meet regulatory requirements) and XLAuditTrail (to make your MS Excel spreadsheets 21CFR Part11 compliant)
Come check us out at Booth #64!
Yesterday, I returned to work after a couple of days recovering at home and I, as I’ve been told today, “pushed myself too hard.” When I woke up this morning I knew there was no way I’d survive the hour long drive to the office because I can’t even get out of bed. However, I have a ton to do and really can’t afford to be out for another full day. My challenge? No laptop! I left my machine at work. My other challenge? Reference the prior “can’t get out of bed” comment.
Normally this would not be an issue for me. I could sit in front of my iMac and connect to our VMware View infrastructure to do whatever I need to do, securely. However the iMac is not made for my lap so I had to figure out another plan. Voilà! We have an old IBM Thinkpad that hasn’t been powered on for at least a year. This laptop is at least 8 years old, but I’ll say it’s 10 to add some effect.
Problem number 1… is this laptop going to power on? Thanks to IBM, Microsoft and all the wonders that are Windows XP, it did. With that minor issue resolved, and a power cord in hand, I crawled back to bed. I then took the following steps:
1. Plugged in Laptop
2. Downloaded the VMware View 4.5 client
3. Installed the client, although I’d rather use the ThinApp
4. Entered connection server name
5. Entered my credentials
6. Launched my Windows 7 VM
How long did all of this take? Less than 5 minutes, which is way less than it took for me to write this post. Honestly, I don’t know why more organizations have not jumped on the Desktop Virtualization train because I just proved that the BYOPC concept works, again. I guess you’re wondering about performance? I don’t notice a difference, seriously. Keep in mind that I’m using SharePoint, CRM, Office 2010, Acrobat, etc., etc… I’m not a video editor. Today I’m a cross between a knowledge worker and power user.
Do you have a different opinion? Let me know!
Interphase Systems, Inc. to Present at the PACT- Next Generation Architecture Summit: Cloud Computing on the Rise
Cloud computing will dominate technology delivery in five years.
With so many issues to explore and evaluate, Business Executives and Technology Decision Makers cannot afford to miss The Next Generation Architecture: Cloud Computing on the Rise.
Learn how cloud computing works and what specific benefits clouds bring to a company’s competitive strategy, data management practice, and profitability.
Join Interphase and other PACT Partners for a full day of breakout sessions and open Q&A. Also stop by our booth location to learn more about Interphase Systems, Inc. and how we can help you achieve your technical and business needs.
To learn more about this event and to register please click on the following link:
We look forward to seeing you there!
Interphase Systems will be exhibiting at the 2010 PDA/FDA Joint Regulatory Conference on September 13-14, at the Renaissance Hotel in Washington, D.C.
Take part in three dynamic learning tracks:
• Foundations: Get back to quality basics in times of change! Sessions will discuss CAPA, inspection management, recalls and quality unit responsibilities.
• Quality Today: Talk about the challenges facing today’s quality professionals including supply chain management, knowledge management and biologics.
• Merging and Emerging Issues: Focus on global regulations, merging quality systems, regulatory communication and foreign inspection practices.
Interphase Systems provides cost effective software products and solutions to meet your regulatory needs. Our risk based validations approach saves you time and money. Showcased products include Ready-CAPA (software to track issues, observations, incidents and improvements to meet regulatory requirements) and XLAuditTrail (to make your spreadsheets 21CFR Part11 compliant)
Come check us out at Booth #31!
Click here for more information on the PDA/FDA Joint Regulatory Conference or if you would like to Register
Check out the view from our seats...