Software Installations on laptops by group other than Information Technology

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Essentially our IT group builds the base laptop (which is considered qualified), deployes the laptop (with local admin rights) to the user (biostatistics employee) where someone from biostats will install all of the remaining software.

Fundamentally I have issues with them having admin rights and installing their own software. I am trying to get an SOP into place for software installations on qualified desktops/laptops where you install it once test it, install it a second time on a diff. machine and test it and if results are the same it can be considered qualified and then just installed from there on any machine in that department. These machines are used for SAS programming and dataset creation.

Is there anything in the regs that point to who should handle the installation of software, admin rights to machines etc.?

Any help / guideance would be appreciated.

2

Good question, in relation to the regs off the top of my head I’m not sure what actual reg this would apply to.

It would be standard practice that IT do all installations.

Couple of questions:

  1. What can’t IT install the SAS program for the Stats guys.
  2. How will you know if the install is done correctly.
  3. Where do they get the software from, is it your companies license.
  4. Are there different SAS modules or different SAS guys.
  5. How are other Software Applications installed and why is this situation different?

Regards