Data Integrity and ALCOA+: More Than a Policy—It’s How Trust Is Built
By Troy Fugate, Vice President, Compliance Insight
If you’ve worked in a GMP-regulated environment for any length of time, you’ve likely heard the term “ALCOA+” more times than you can count.
And yet—year after year — data integrity violations remain among the top reasons for FDA 483s, Warning Letters, and import alerts.
Why? Because organizations too often treat data integrity as an IT problem or a checklist, when in reality, it’s a cultural and behavioral discipline that must be embedded into every system, procedure, and person.
Let’s break it down — what ALCOA+ really means, and what it takes to make it real inside your organization.
What Is ALCOA+?
ALCOA+ is the global benchmark for data integrity expectations in regulated life sciences. The acronym stands for:
- Attributable – Who performed the action? When?
- Legible – Can the record be easily read and understood?
- Contemporaneous – Was it recorded at the time the activity occurred?
- Original – Is this the first-generation data or a verified true copy?
- Accurate – Is the data free from error and faithful to the process?
The “+” adds additional expectations that reflect regulatory evolution:
- Complete – All data is included, not just what supports the outcome
- Consistent – Time-stamped in expected sequence, with no unexplained gaps
- Enduring – Data is retained and protected throughout its lifecycle
- Available – Records are readily retrievable for review or inspection
Why ALCOA+ Matters
In regulated manufacturing, data is the product until the product is released.
You can build the perfect facility, run validated equipment, and train a top-tier team — but if the records supporting your release, deviation, or investigation are incomplete or questionable, your product—and your credibility—are at risk.
The FDA and EMA both consider data integrity a foundational pillar of GMP. It’s not just about documentation — it’s about demonstrating control, accountability, and transparency.
Common Pitfalls We See
At Compliance Insight, we’ve reviewed hundreds of data integrity systems across the industry. Here are some real-world gaps we encounter far too often:
- Operators writing results on scrap paper, then entering them later
- Audit trails turned on—but never reviewed
- Laboratory systems with shared logins or weak access controls
- Incomplete records for sample preparation or deviation handling
- Batch records with unexplained overwrites or backdated entries
- Lack of traceability in spreadsheets, instruments, or hybrid systems
Each of these signals to an inspector: “We don’t have control.”
What You Can Do
To move from policy to practice, here’s what we recommend:
- Assess, Don’t Assume
Perform a site-wide data integrity gap assessment. Look at both digital and paper systems. Map data flow from generation to storage. Check against ALCOA+.
- Simplify SOPs and Expectations
Too many procedures are vague or overly technical. Make your ALCOA+ expectations clear, visual, and role-specific. Reinforce in onboarding and annual training.
- Build Real-Time Oversight
Train QA and supervisors to spot data integrity signals on the floor—not just in audits. Engage in “quality on the floor” walkarounds that reinforce vigilance.
- Control Access and Review Audit Trails
No system is compliant if anyone can edit data without traceability. Enforce access restrictions, and review audit trails routinely — not just after an issue.
- Make It a Culture, Not a Campaign
This isn’t a one-time training or a slide deck. It’s about building habits, accountability, and courage to report concerns. Speak-up culture matters here.
Final Thought: Trust Is Earned in the Details
Data integrity isn’t about perfection. It’s about authenticity and accountability — knowing that what you document is what actually happened, and that you can explain it with confidence.
At Compliance Insight, we don’t just teach ALCOA+—we help your people live it. From lab audits and system reviews to SME coaching and inspection readiness, we make sure your records hold up — because your product, your patients, and your license depend on it.
If you’re not sure your team’s data integrity systems are inspection-ready, let’s talk.
The FDA won’t just look at your records — they’ll read your habits.