Missed an edition of The Data Dish?
No worries—we’ve packed up every newsletter like leftovers from a Michelin-starred meal.
Welcome back, Data Diners! 🍽️
We’ve covered ALCOA, but now it’s time to zoom out and look at the bigger picture—the entire lifecycle of data. Just like a dish moves from ingredients to plating, your data follows a structured journey from creation to its final archive.
The question is: Do you know where your data goes after it’s "served"? If not, you might have a compliance gap bigger than an overcooked soufflé.
Your data isn’t just born, used, and forgotten—it moves through distinct stages, each with its own risks and compliance requirements.
📌 What Happens? Data is first generated, whether it’s a batch record, lab result, or equipment log.
🔍 Risk: If data isn’t recorded completely and correctly at this stage, errors multiply downstream.
✅ Best Practice: Ensure real-time, attributable entries and use templates or automation to minimize errors.
📌 What Happens? Data is analyzed, reviewed, and approved. Lab results go through calculations, manufacturing records get verified, and deviations are assessed.
🔍 Risk: Data that is manually transcribed or modified without traceability can lead to regulatory trouble (hello, FDA Warning Letters! 👀).
✅ Best Practice: Implement audit trails and ensure electronic systems track every modification.
📌 What Happens? Approved data is stored for future reference, regulatory checks, and trending. This can be paper-based (archives) or digital (validated electronic systems).
🔍 Risk: Lost, damaged, or altered records can land you in hot water faster than a prize lobster handpicked for the plate!
✅ Best Practice: Store records in validated, secure systems with controlled access and backup measures.
📌 What Happens? Auditors, QA teams, or investigations might require past data. Can you retrieve it quickly?
🔍 Risk: Poor organization or missing metadata makes retrieval a nightmare during inspections.
✅ Best Practice: Index data systematically with unique identifiers to find and retrieve it in minutes (not hours).
📌 What Happens? After regulatory-required retention periods, data is either archived or destroyed.
🔍 Risk: If data is deleted too early, it’s a compliance violation. If kept too long, it clutters systems.
✅ Best Practice: Follow official retention schedules and ensure destruction is documented and controlled.
Grab a whiteboard, sticky notes, or a digital mapping tool like Lucidchart or Microsoft Visio. Outline:
✔️ How data is created in your process
✔️ How it’s reviewed and approved
✔️ Where it’s stored and for how long
✔️ Who accesses it and when
✔️ How it’s retired or destroyed
💡 Pro Tip: Map one critical document (like a batch record) and see if you can trace its entire journey. At every step along the way, apply the five main ALCOA principles and look for gaps.
If any step has a gap, that’s a potential compliance risk.
We’ll be diving into Data Governance—setting the table for integrity. If your workplace lacks support for data integrity, lack of ownership or a poor GMP culture, then navigating a successful Data Integrity program may have some serous hurdles to jump!
Stay tuned, and keep your data fresh and audit-ready! 🚀
Bon appétit,
The Data Dish Team 🍽️
Email: [email protected]