Healthcare Regulatory SAS Project
Please find under a summary covering project details and feedback. The innate facts are kept as they are, private information is amended.
Introductory information
Can you prepare a brief description of your organisation?
We are a very big software developer organisation and software manufacturer. We have 4,000 employees. Our centre is on business analytics software at a high level.
What is your role and responsibilities?
You can ponder of me as a project director. I work in the consulting structure as a project director.
Desired goal
What were your organisation’s business goals for this particular project?
In general, we use Pinnacle a lot. We use them a lot to do the installations and configurations of our software. They’re very good at that.
I named on Pinnacle to help out behind they did the installation of a SAS method. We needed to reinstall the software in a validated environment for pharmaceutical companies that are developing drugs. This project required installation of both the hardware and software. Everything they do needs to be documented very well for the FDA, and there’s a structured process to do what’s named IQ/OQ/PQ so Installation Qualification, Performance Qualification, or Operational Qualification and Performance Qualification – IQ/OQ/PQ, 21 CFR Part 11 bylaws.
Provided solution
What was your process for selecting Pinnacle Solutions for this project?
I have worked with them on dozens of projects. Pinnacle has at littleest one or two individuals that are excellently good at knowledge the federal requirements and precisely what needs to be done. I without got Pinnacle implicated.
Can you draw the project in more detail and what parts Pinnacle Solutions was implicated in?
There are specific rules that the FDA requires for methods to be installed and managed when they’re developing drugs to be approved by the FDA. That’s a very specific expertness set that not many nation know how to do, but Pinnacle does. They scoped it out, and completed the project successfully.
Can you prepare a perception of the start in dollar provisions?
We’re talking $60,000 to $70,000 for this little project. The business that we’re intercourse with is a little to midsize business, so see dollar counts.
Results achieved
How did Pinnacle Solutions accomplish during the project?
They’re just fantastic, probably one of the best vendors I deal with.
What is sole or particular almost them compared to some of the other vendors that you worked with?
They’re exceptionally good with client labor. They don’t rely on SAS. Sometimes, it can be very tricky to instrument SAS software. They aspect it out on their own. They’re very keen and can aspect it out. I ponder they have good experience outside of SAS with Unix and Linux.
Is there any area that you ponder they could better upon or you would do differently?
No. Not veritably.
