Good Documentation Practices (GDocP)

In the Life Sciences industry, documentation is far more than a simple communication tool: it forms the foundation of compliance, traceability, and trust. Without shared conventions and standardized practices, the correct and secure transmission of information would be impossible, as each individual would record, interpret, and use data according to their own methods. This would create dangerous discrepancies in how activities are understood and executed. A manufacturing instruction could be misinterpreted; a laboratory test performed differently depending on the operator, or a correction made improperly and thereby compromise data integrity. The absence of strict rules can rapidly lead to inconsistencies, loss of traceability, and an inability to demonstrate compliance to regulatory authorities. Critical decisions end up being based on ambiguous, incomplete, or unverifiable information, increasing operational risks and, ultimately, risks for patients. This is precisely why Good Documentation Practices (GDocP) exist. As organizations operate in an increasingly complex technological and regulatory environment, documentation rigor remains a fundamental pillar of compliance and of the broader GxP framework that encompasses the laws and regulations governing the Life Sciences industry. 

1. What Are Good Documentation Practices? 

Good Documentation Practices (GDocP) represent a set of rules, standards, and behaviors designed to ensure that any information recorded within a GxP environment is reliable, complete, and suitable for demonstrating the compliance of a process or a system. They define the correct way to create, modify, manage, retain, and protect documentation to ensure that each piece of data accurately reflects the activities performed and can be interpreted unambiguously by any authorized individual. GDocP therefore govern both the form (readability, dating, signing, version control) and the content, ensuring that documentation supports traceability, transparency, and accountability. By establishing uniform expectations for all stakeholders involved in GxP processes, they enable organizations to consistently demonstrate that their operations are controlled, their products meet quality standards, and their decisions are based on reliable, verifiable information. 

2. What Types of Documents Are Covered? 

“Documentation” in a GxP environment includes a wide range of documents and records. Here’s a non-exhaustive list: 

Documents 

• Standard Operating Procedures (SOPs), work instructions, policies 

• Protocols, study or tests plans 

• Forms, templates, logbooks 

• Job descriptions or responsibility matrices when linked to GxP processes 

  
  

Records 

• Evidence of activity execution 

• Analytical results 

• Incident or investigation reports 

• Raw data generated by instruments 

• Electronic logs and audit trails 

• Signatures, dates, and timestamps 

  
  

The purpose of this documentation is to demonstrate compliance, ensure reproducibility, and support quality decisions based on trustworthy information. 

3. Who Must Comply with GDocP? 

GDocP apply to any department whose activities influence, directly or indirectly, a GxP process, including: 

• Manufacturing and operations 

• Laboratories and R&D 

• Supply chain and distribution 

• Engineering, maintenance, qualification/validation 

• Regulatory affairs 

• Sales teams when interacting with GxP-relevant information 

  
  

Internal employees, contractors, suppliers, distributors, and any partner involved in these activities are required to comply fully with GDocP. 

4. Data Integrity: A Core Pillar 

Data integrity has become even more critical due to: 

• The rise of interconnected electronic systems 

• Increased scrutiny of data audits 

• Growing cybersecurity risks 

• Strengthened requirements for audit trail review 

  
  

Data integrity means that information must remain accurate, complete, and trustworthy from its creation to its archival. Several risks can compromise this integrity, such as: 

• Human errors (accidental or intentional) 

• Incorrect transcriptions or data transfers 

• Improper use of electronic systems 

• Insufficient cybersecurity measures and controls 

• Lack of knowledge or training on GDocP 

  
  

5. The ALCOA+ Principles 

The ALCOA principles were introduced in the 1990s by the U.S. Food & Drug Administration as a framework to ensure data quality, as documented by Stan W. Woollen in Data Quality and the Origin of ALCOA (Woollen, S. W. (2010). Data Quality and the Origin of ALCOA. Rx-360). The transition to ALCOA+ took place during the 2010s, when regulators such as the European Medicines Agency expanded expectations for data integrity within electronic records, as reflected in its 2016 communication Data Integrity – Key to Public Health Protection (European Medicines Agency. (2016). Data Integrity – Key to Public Health Protection. EMA). Today, ALCOA+ remains the industry standard for data integrity and applies to all data and records, whether paper-based or electronic. According to these principles, data must be: 

A — Attributable 

The author must be identifiable with its initials, a signature, and a secure electronic ID. No data may be created or modified by an unauthorized person. 

L — Legible 

Information must remain readable and interpretable throughout its entire lifecycle. Corrections must not obscure the original entry. 

C — Contemporaneous 

Data must be recorded at the time the activity is performed. Electronic systems must be correctly time-stamped. 

O — Original 

The first capture of data is considered the original record. Copies must be controlled and verified. 

A — Accurate 

Data must reflect the actual activity performed. Any modification must be justified, dated, and documented. 

The “+” Elements 

• Complete: No information should be missing. 

• Consistent: Data must be logical and aligned across versions. 

• Enduring: Accessible and retained for the required regulatory period. 

• Available: Readily retrievable at any time by authorized personnel. 

  
  

6. Consequences of Poor Documentation 

Even in 2025, deficient documentation remains one of the most frequently cited observations during FDA (Food and Drug Administration) and EMA (European Medicines Agency) inspections. The well-known phrase “If it is not documented, it did not happen” is more relevant than ever. 

Common findings include: 

• Missing or outdated procedures 

• Incomplete or illegible records 

• Audit trails not reviewed 

• Undated or unsigned documentation 

• Lack of justification for corrections 

• Use of uncontrolled documents 

  
  

These issues may lead to: 

• Product recalls 

• Production shutdowns 

• Regulatory warnings (FDA Form 483, Warning Letters) 

• Loss of certification 

• Major risks to patient safety 

  
  

7. Key Recommendations 

To do  

• Use only controlled, up-to-date documents 

• Record activities in real time 

• Correct errors with clean, dated, and signed annotations 

• Use a standardized date format (e.g., ISO 8601) 

• Use indelible ink or a compliant electronic signature 

• Complete all fields or cross out those not applicable 

• Number all pages (e.g., “1/3”) 

• Preserve original data and audit trails 

• Sign and date every record 

  
  

Do not  

• Use sticky notes as official documentation 

• Erase or obscure any data 

• Modify a document before proper review/approval 

• Record information from memory 

• Use correction fluid or any tool that removes information 

• Remove a page from a GxP document 

• Leave blank fields without justification 

Conclusion 

Organizations in the Life Sciences and other regulated sectors operate in an environment where data reliability is fundamental to patient safety, product quality, and regulatory compliance. Good Documentation Practices are no longer just a set of rules, they represent a true framework of professional discipline. Mastering GDocP is now a strategic advantage, supporting operational performance and strengthening trust with authorities and business partners. Rigorous, clear, and complete documentation remains, and will continue to be, the foundation of all GxP activities.

At InnovX, we can support you in developing your operational procedures or in applying Good Documentation Practices so that you remain compliant with regulations and aligned with the standards governing your sector—particularly within a GxP framework.

Contact us today to learn how we can help your organization.