Category Archives: Computer Systems Validation

Records Management in SharePoint Online

Records Management

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

Can SharePoint Online be Compliant?

Microsoft_SharePoint_2010_Foundation

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?

Considerations in SaaS Validation

SaaS Qualification

Hello good people of the world! Today’s post is about qualifying Software as a Service (SaaS), also known as “cloud-based” or “hosted” software. Simply, SaaS is any computer system in which any server is not hosted by the system owner. Here are some key considerations in qualifying SaaS computer systems:

Continue reading Considerations in SaaS Validation