I have done an FDA related project for a huge pharma company. It was an extremely laborious process to generate the documentation required for the requirements for the application, functional specification, design specification and then on the installation, maintenance, operations and process control documents. For a very simple product, Citrix License Server, it took me months (MONTHS!!!) to create all the necessary documentation. I then had to legally sign each document meaning if there ever was an FDA investigation, I could be held legally liable for what I put in the documents I created as the primary author.
The license server was then forever tied to a specific VM configuration, specific OS version and update level and specific product version and update level. NOTHING could ever be changed on the server was it was installed, configured and validated. Thanks Webster -----Original Message----- From: [email protected] [mailto:[email protected]] On Behalf Of Mark Liechty Sent: Monday, November 16, 2015 9:24 AM To: [email protected] Subject: Re: [NTSysADM] Blocking Java, Google, Adobe automagic updaters On Nov 16, 2015, at 6:33 AM, Richard Stovall <[email protected]> wrote: > > Understood. I totally get that there are valid reasons to retain old > versions of Java for some very specific use cases. But Reader/Acrobat? > Chrome? And heaven forbid, Flash? > ######### I worked with a medical device company a few years ago that was very specific about the Adobe Reader version. They have very complex QA around any changes to the processes of any kind. Rules come from the FDA, Legal Department and lots of other strangeness that It cannot, and should not, control. It seems that at one point the PDF documents that were generated by some other process did not display properly when looked at by the newest version ##.### of Adobe but were perfect when using version YY.YYY since opening these documents was required for each device as it came from assembly (had testing results) we could not use the latest versions. Added to that ANY change at any point in the process required a complete end-to-end revalidation\certification that was a very detailed process. So we stayed with the old versions and moved on. My last contact was 5 years later and they still had not been able to change. What they had worked and there was no motivation to upgrade for the sake of being “new and shiny”
