Are Good Documentation Practices (GDP) the Same As ALCOA+?

By: Roy R. Bearry

In working in the MedTech arena for over 25+ years, I still get the question “Are Good Documentation Practices (GDP) the same as ALOCA+?

The short answer: Good Documentation Practices (GDP) are the broad, system‑level rules for how regulated organizations must create, manage, and maintain documentation. ALCOA+ is the data‑integrity standard that defines what makes each individual data entry trustworthy.

GDP is the framework. ALCOA+ is the quality standard applied to each record within that framework.

🔍 Core Difference (Most Important Distinction)

GDP = the process rules How documents must be written, controlled, corrected, stored, reviewed, approved, and archived across the entire GxP system. Examples: SOP formatting, version control, correction rules, record retention, training, logbook structure.

ALCOA+ = the data integrity attributes The characteristics every data point must have to be considered reliable:

• Attributable

• Legible

• Contemporaneous

• Original

• Accurate + Complete, Consistent, Enduring, Available 

GDP uses ALCOA+ as its foundation. ALCOA+ is embedded inside GDP, but GDP covers much more than data integrity alone.

🧩 How They Relate

Think of it this way:

Concept	What It Covers	Scope	Regulatory Purpose
ALCOA+	Data integrity attributes	Individual entries	Ensures each recorded value is trustworthy
GDP	Documentation systems, controls, behaviors, and procedures	Entire documentation lifecycle	Ensures the whole documentation system is compliant, traceable, and audit‑ready

GDP = the rules for documentation systems. ALCOA+ = the rules for data integrity inside those systems.

📘 What GDP Includes (Beyond ALCOA+)

GDP covers:

• How to write entries (ink, corrections, no blank fields)

• How to structure logbooks and batch records

• How to manage revisions and version control

• How to archive and retrieve documents

• How to train personnel on documentation

• How to ensure SOPs are usable and aligned with operations

GDP is aligned with global frameworks such as FDA 21 CFR Part 11, EMA Annex 11, and WHO TRS 996.

📗 What ALCOA+ Adds

ALCOA originally included:

• Attributable

• Legible

• Contemporaneous

• Original

• Accurate

ALCOA+ adds:

• Complete

• Consistent

• Enduring

• Available 

These attributes ensure that anyone—an auditor, inspector, or colleague—can reconstruct exactly what happened without explanation.

🧠 Practical Example

Scenario: An operator records a pH measurement.

• ALCOA+ requirement: The entry must be attributable (signed), contemporaneous (written at the time), accurate, original, complete, consistent, enduring, and available.

• GDP requirement: The logbook must be controlled, formatted correctly, versioned, stored properly, corrected according to SOP, and retained per policy.

ALCOA+ governs how the entry is made. GDP governs how the record is managed.

🏁 Final Takeaway

GDP = the full documentation system. ALCOA+ = the integrity standard for each piece of data within that system.

GDP cannot function without ALCOA+, and ALCOA+ has no meaning without GDP. They are complementary—but not interchangeable.

If your organization is ready to strengthen documentation practices, improve data integrity, and build audit‑ready systems, M.E. Dorat Consulting can help you get there. Visit 👉 www.medoratconsult.com or schedule a consultation.