🍽️ The Data Dish #6: Accurate Data: No Room for Fluff

Hey there, data defenders! 👋

Welcome to your weekly serving of data integrity wisdom. This week, we’re diving into the A for Accurate in ALCOA. No shortcuts, no guessing games—accurate data is the heart of compliance, safety, and, let’s face it, your peace of mind.

You wouldn’t eyeball the salt when baking a soufflé, right? Same goes for your GMP activities. Accurate data is what keeps patients safe and auditors happy. Let’s get into it!

🍳 The Meat & Potatoes: What Accurate Really Means

Accurate data is data that’s error-free, truthful, and precise. In the world of GMP, that means no fudging numbers, no guessing values, and no sneaky tweaks. Accuracy builds trust in your processes and products—and the FDA has no tolerance for anything less.

Here’s how accuracy plays out across different settings, along with the FDA requirements that keep things in check:

🔬 Laboratory Example

Scenario: A lab technician uses HPLC to test raw material samples for identity, purity, and strength.
FDA Expectations in Action:

• Equipment must be calibrated and validated to ensure reliable readings (21 CFR 211.68).

• Test results must be documented immediately and reflect the actual observed values—no “guesstimates” (211.160).

• A second technician or automated system must verify test data and calculations (211.194).

• Audit trails must show no unauthorized changes to data (21 CFR Part 11).

✨ Lesson: In the lab, accuracy starts with calibrated equipment and ends with clear, tamper-free records.

🏭 Manufacturing Shop Floor Example

Scenario: An operator measures the volume of an API for a batch.
FDA Expectations in Action:

• Weighing and measuring equipment must be routinely calibrated (211.68).

• The operator must record the exact weight or volume, no rounding or editing (211.100).

• Any deviations must be documented, investigated, and resolved (211.192).

• Supervisors must verify the records for accuracy before batch approval (211.186).

✨ Lesson: Precision on the shop floor ensures every batch meets its intended quality—and protects patient safety.

📜 Paper Record Example

Scenario: A QC analyst documents stability test results on a paper form.
FDA Expectations in Action:

• Results must be written clearly and legibly—no white-out or creative cover-ups (211.186).

• Any corrections must include the original data, reason for the change, and initials of the person making the correction (211.194).

• A reviewer must verify the accuracy and completeness of the data (211.194).

• Forms must be stored securely to prevent tampering (211.68).

✨ Lesson: Paper records are like your grandma’s recipes—keep them clean, complete, and untouched by questionable edits.

💻 Electronic Record Example

Scenario: A technician logs batch test results into a LIMS.
FDA Expectations in Action:

• LIMS software must be validated to ensure accurate data entry and calculations (21 CFR Part 11).

• Audit trails must show timestamps for data entry, modifications, and approvals (21 CFR Part 11).

• Access to the system must be controlled, allowing only authorized personnel to modify data (211.68).

• Electronic records must include raw results, calculations, and all supporting data (211.194).

✨ Lesson: Electronic records don’t just store data; they tell a story. Make sure it’s an accurate one.

🍽️ The Data Dish Takeaway:

Whether you’re in the lab, on the shop floor, or managing records, accurate data is non-negotiable. The FDA’s expectations are clear:

1. Use validated systems and calibrated equipment.

2. Record data immediately and exactly as observed.

3. Protect data integrity with controlled access and audit trails.

Getting it right every time doesn’t just keep you compliant—it keeps patients safe and builds trust in your work.

Now that we’ve served up the full ALCOA course, you might be thinking, “What’s for dessert?” Well, here’s a little teaser for next week’s newsletter: ALCOA+.

What’s the “+,” you ask? It’s the extra garnish on your compliance sundae—the modern extensions to ALCOA that take data integrity to the next level. Think of it as the “chefs’ kiss” to your GMP practices. 😘

Stay tuned for next week’s edition, where we’ll explore what the + stands for, why it matters, and how it helps you go above and beyond in the world of data integrity.

Have a data accuracy dilemma or a scenario you’d like us to explore? Drop us an email, and we’ll cook up some answers in the next edition! 👩‍🍳

Stay accurate and awesome,
The Data Dish Team