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:
- I need to write a formal functional requirements spec.
- Said spec needs to survive the approval challenge.
- I need to buy the new server
- Initiate purchase request
- have purchase request approved by several people
- wait until budget allocation has been done
- wait until order is ready for ordering
- get someone to initiate the order
- 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.
- 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.
- Initiate a change request, discuss the proposal with change request committee (with a detailed action list) and get approval for change.
- 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, …
- 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.
- Initiate document review workflows to let different deparments review said documents.
- Validate those documents with a witness, by reinstalling and reconfiguring said server according to the instructions written down in the manuals.
- Perform actual installation on the production network, fill in all the manuals as proof of execution.
- Have validation perform a funtional validation, based on the initial requirments.
- Update the network drawings
- Gather all the evidence and documentation of everything that was changed, scan it, and attach it to the change request workflow
- 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.