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
Hello good people of the world! Today’s post covers some of the “golden rules” on aseptic biopharmaceutical manufacturing facility design. Please add yours in the comments below! Continue reading Golden Rules for Aseptic BioPharmaceutical Manufacturing Facility Design
Hello good people of the world! Today’s post is about Piping and Instrumentation Drawing (P&ID) verification. Of course, the P&ID is one of the most important design documents for a given system, detailing piping configuration and class, major component location and details, instrumentation, and control points, and thus is an important part of any commissioning and qualification effort. Continue reading Considerations in P&ID Verification