CS-Inventory

🚦 Do you really know which systems manage your critical data?

Most organizations are confident they do — until an auditor shows up and asks one simple question:

“Can I see your list of systems?”

Quite often, a system or two is missing from that list, along with several other oversights, and suddenly the questions about control start to snowball. This is actually the easiest way to spot the gaps — and see how well the “wallpaper sticks to the wall.”

According to EU Annex 11 and FDA 21 CFR Part 11, every organization operating under GxP requirements must maintain an up-to-date, complete, and reliable list of information systems that affect product quality, data integrity, and decision-making.

Yet in many places, this list is scattered across Excel files, with no clear ownership or ongoing maintenance.

💡 A few tips that can change everything:

1️⃣ Assign an owner to each system — QA, IT, and the business must share one agreed-upon source of truth.

2️⃣ For every system, record its validation status, risk level, and business/quality criticality.

3️⃣ Update changes only through a formal change control process.

4️⃣ Ensure the list supports periodic review and complete update tracking.

Because your list of computerized systems isn’t just a form — it’s your map of control in the world of information.

And that map must be based on knowledge, control, and the principles of #DataIntegrity.

📍 If you don’t yet have one — maybe it’s time to start.

✨️✨️✨️

And about the photo — it’s the order of utensils in a kitchen that’s not mine. But even in my own kitchen, I’m definitely not in charge. Let’s just say, in the words of some of my closest friends, “those who value their peace of mind, stay away.”

When it comes to organizing system inventory lists, though — that’s my specialty.

I’m absolutely here for you — just a WhatsApp away.