LinkedIn·Thursday, 20 August 2026·6d ago
Validation has a lifecycle. Your system does too. Going live in a validated state is only the beginning. Changes happen. Access evolves.…
Scilife
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Validation has a lifecycle.
Your system does too.
Going live in a validated state is only the beginning. Changes happen. Access evolves. Suppliers update their services. Incidents occur. New risks emerge.
And that’s exactly why “validated” can’t be treated as a one-time milestone.
EU GMP Annex 11 expects computerized systems to remain under control throughout their lifecycle — with validation effort proportionate to intended use, complexity, and risk.
So the better question isn’t:
“Did we validate the system?”
It’s:
“Can we demonstrate that it remains validated?”
Swipe through for a practical look at what that means — and how Annex 11, GAMP 5, and 21 CFR Part 11 fit into the picture.
And if that leaves you wondering where Annex 11 actually covers, how it compares with GAMP 5 and FDA 21 CFR Part 11, or what the 2025 draft could change, we’ve gone deeper in our latest guide.
👉 Read the full article here: https://lnkd.in/eVSHWtmi
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