Documentation and paperwork

I haven’t had the time to write up anything interesting this week because I had to replace a fileserver on my network. Rplacing the server itself and restoring the data took only a couple of hours, but I am still working on the paperwork. You see, working in the pharmaceutical industry means paperwork and bureaucracy. Lotas and los of both.

By the time I am ready I am ready with everything, I will have wasted a square meter of rainforest worth of paper, AND those trees will have had the time to grow back. Installing new equipment is certainly a challenge. Let’s see if I can give a short overview:

  1. I need to write a formal functional requirements spec.
  2. Said spec needs to survive the approval challenge.
  3. I need to buy the new server
    1. Initiate purchase request
    2. have purchase request approved by several people
    3. wait until budget allocation has been done
    4. wait until order is ready for ordering
    5. get someone to initiate the order
    6. wait until the actual order has been approved at several levels. this depends on the total price. For anything more expensive than a ham sandwich, this road can be long and treacherous.
    7. wait for delivery. During this process, the supplier calls every now and again to see if something is wrong because it is taking so long.
  4. Initiate a change request, discuss the proposal with change request committee (with a detailed action list) and get approval for change.
  5. server arrives, I have to figure out how to install and configure it, and how to perform all normal maintenance. This includes backup and recovery, user management, …
  6. write down detailed installation manuals that explain exactly how end up with a fully configured system, and how to configure and perform backup, recovery, management, … And by ‘detailed’ I mean that every single mouseclick or checkbox selection has to be written down.
  7. Initiate document review workflows to let different deparments review said documents.
  8. Validate those documents with a witness, by reinstalling and reconfiguring said server according to the instructions written down in the manuals.
  9. Perform actual installation on the production network, fill in all the manuals as proof of execution.
  10. Have validation perform a funtional validation, based on the initial requirments.
  11. Update the network drawings
  12. Gather all the evidence and documentation of everything that was changed, scan it, and attach it to the change request workflow
  13. Have change request appected and signed.

Working on a pharmaceutical process control network, I understand that there is no other option but to do things formally at every level. But this sadly also means that ‘just installing a fileserver’ is something that cannot be done.

Leave a Reply

Your email address will not be published. Required fields are marked *