🍽️ The Data Dish #4: Let’s Get Original! 🧑‍🍳✨

🎉 Welcome back, Data Dishers! We hope your holidays were merry, bright, and full of compliant documentation. Now that the New Year is in full swing, we’re dishing out the fourth course in our ALCOA feast, focusing on Original—the "O" in ALCOA.

What’s Cookin’? Originality in Compliance

Being Original doesn’t mean your data has to win a creative writing contest—it means ensuring that the first record of your data is authentic and unaltered. Think of it like preserving the recipe card from your great-grandma: it’s the true source, and you don’t want anyone tampering with it.

Key Ingredients of Originality:

• Raw Data Preservation: Original records, whether electronic or paper, should remain intact and unedited.

• Audit Trails: Every change must leave breadcrumbs to track how, when, and why it was made.

• Source Documents: Copies or summaries can’t replace the real deal. Keep that raw data safe!

Here’s how "Original" plays out across different areas of GMP compliance, with real-life flavor added:

🧪 In the Lab: The Case of the Phantom Chromatogram

A lab analyst ran an HPLC test on a batch of active pharmaceutical ingredient (API). Instead of saving the original chromatogram, they printed the results, adjusted the baseline on the printed graph, and tossed the electronic file. This was a major no-no! The original electronic record (with its unedited peaks and valleys) is the authentic source and needs to be retained for audit and review.

🔑 Lesson: Always retain the raw data—the original chromatogram in this case. It’s the only way to prove the test results are accurate and untampered.

🏭 On the Manufacturing Floor: Batch Sheets Matter

During the production of a drug product, an operator forgets to record a key temperature reading on the batch manufacturing record (BMR). Realizing the oversight later, they "recreate" the missing data based on a verbal confirmation from another operator. The recreated data is now unauthentic—it’s not the original observation and violates data integrity principles.

🔑 Lesson: Record data at the time of the activity. If you miss it, document the omission and the reason—don’t "guess."

📝 Paper Records: That Time Someone Played White-Out Hero

In a facility using paper records, a quality control analyst accidentally records the wrong pH reading for a sample test. Instead of correcting it properly, they use white-out (yes, really) to fix the number. The result? A compromised original record with no trace of the initial error.

🔑 Lesson: Corrections to paper records must be made with a single line through the error, initialed and dated by the person making the correction.

💻 Electronic Records: When Audit Trails Tell All

An employee at a pharmaceutical company edits an electronic batch record after production is completed—without documenting the reason. The system’s audit trail flags the change, but the company cannot explain why the original data was altered. Regulatory inspectors smell trouble, and the company faces serious repercussions.

🔑 Lesson: Ensure your systems have robust audit trails and require justification for any data modifications. Always retain the original data, even after changes are made.

Upcoming Events & Training

Stay ahead of the compliance curve with these upcoming sessions:

HPLC Data Integrity
Date: January 22/23, 2025
Format: Live Online Training
Overview: This Live Online Training will deal with helping attendees understand the latest USP and DI requirements for the successful application of HPLC in a regulated GMP laboratory.

GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course
Dates: February 4–6, 2025
Format: Online Live
Overview: This course covers data integrity, electronic records and signatures, and the compliant operation of GxP computerized systems, providing tools and techniques to implement proper controls for data throughout its lifecycle.

Got a question or scenario about "Original"? Send it our way—we love serving up compliance insights with a side of practical advice! 🍴

Stay tuned next week for the final "A" in ALCOA+. You won’t want to miss it!

🍴 Don’t forget to subscribe or share this dish with your compliance crew!

Until next week, stay compliant and keep it original! 👨‍🍳✨