Validation can wait!?
Picture it …
Problems occur in production which need to be fixed immediately, because the supply chain will stumble or need to be stopped at worst. All other work must be shunted to a later time until the problem is solved. Finally, you made it and the daily work needs your intention back. Suddenly - you are in a good mood to work through your mails - the validation guy calls. He asks you for the review of the document that lays on your desk for almost several weeks. Your signature is necessary right now. He reminded you several times. Thus, you cannot blame him for it.
Does this look familiar to you?
You push your mails aside and perform the document review - in record time. Everything seems to be fine. You sign it and send it back to the validation colleague.
Suddenly you realize that there are a few more documents to review and sign. You panic: ‘When should I do that?’ The wave of postponed validation issues tower up in front of your desk. Dark clouds appear over this huge pile. It is getting darker and darker in your office. The wind raises and is getting stronger and stronger. And suddenly heaven opens its gates. The validation angel descends!
I know it appears exaggerated!
But sometimes it feels exactly like this. And it shows that heaven can wait, but validation cannot !
For a regulated company it is an essential part of the daily work, not only for the validation team but for each colleague in your company.
Therefore, validation has to be adapted to your business, production and working processes.
Validation has to be precise for your computerized systems.
And validation has to be tailormade for your company to ensure patient safety, product quality and data integrity.
This is CSVapt!