Hello good people of the world! So every project needs to track open items and that is typically done with a punchlist. You may have seen a punchlist in a Microsoft Excel spreadsheet, with one person as the owner, or even worse, on pen and paper.
A punchlist is a collection of data, and any good data collection is:
Continue reading Free Offer! Track Punchlist Items in Real-time with Your Mobile Device
Hello good people of the world! Today’s post is on the FDA’s guidance on Mobile Medical Applications, which can be found here. Mobile apps are becoming more and more a part of everyday life, and it only makes sense that they will be used in healthcare more as well. What are the FDA’s concerns around mobile apps? Continue reading The FDA on Mobile Apps
Hello good people of the world! On May 15, 2016, the World Health Organization released its draft Guidelines on Validation. It is available on the WHO website for download here.
This post covers my review of the guidance. Continue reading WHO’s Draft Guidelines on Validation May 2016
Hello good people of the world! This post is the first in a series on tracking C&Q (Commissioning and Qualification) deviations in a SharePoint site. This implementation assumes approvals are still done with wet signatures so there are no 21CFR11/Annex 11 compliance concerns.
An important consideration when using any software to replace existing paper methods is records management. This is especially true in regulated environments, where laws may enforce requirements around record retention, control, and auditing. This post covers records management in SharePoint Online. Continue reading Records Management in SharePoint Online
SharePoint is an off-the-shelf configurable software solution that has been offered by Microsoft since 2001. It is popular in many industries (including Biotech, Pharmaceutical, and Medical Device) for document management, local Intranet, and many other applications. However, if SharePoint is being used for any GxP purpose, you better believe it is subject to 21CFR11 and/or Annex 11. Continue reading Can SharePoint Online be Compliant?
Hello good people of the world! Today’s post is on the commissioning and qualification of instruments used in process measurement and control. Instruments may be used to measure such things as flow, temperature, pressure, level, weight, conductivity, etc. In use, many of these parameters may be quality critical, so proper commissioning and qualification is key! Continue reading Commissioning and Qualification of Process Instrumentation