Good Documentation Practice (GDocP) helps regulated organizations create and maintain trustworthy records. It covers how information is recorded, corrected, reviewed, retained, and retrieved in both paper and electronic formats.

A completed form or electronic signature does not, by itself, establish that the underlying information is reliable. Missing entries, unexplained changes, shared accounts, and incomplete source data can make activities difficult to reconstruct.

This guide explains practical documentation controls, the ALCOA+ principles, and ways to strengthen data integrity across the record lifecycle. Apply these practices alongside the requirements relevant to your product, activity, and jurisdiction.

What Is Good Documentation Practice (GDocP)?

Good Documentation Practice is a set of principles and controls for creating and maintaining clear, accurate, complete, and traceable records. It helps organizations demonstrate what was done, who performed the activity, when it occurred, and what results were obtained.

GDocP applies to paper and electronic documentation. Examples include manufacturing records, laboratory results, equipment logs, training records, and investigation reports.

The abbreviation GDocP helps distinguish Good Documentation Practice from GDP, which commonly refers to Good Distribution Practice. Define these terms in your procedures and training materials to avoid confusion.

How Does GDocP Support Data Integrity?

Good Documentation Practice supports reliable recordkeeping through clear instructions for recording, correcting, reviewing, and retaining information. Data integrity also depends on how that information is protected and managed throughout its lifecycle.

For example, an analyst may record a result correctly, but its reliability can still be compromised if another user can change or delete it without appropriate authorization or traceability.

• Clear responsibilities for creating and reviewing records.
• Appropriate access permissions.
• Preservation of original information and relevant context.
• Traceable corrections and changes.
• Secure retention and reliable retrieval.
• Investigation of discrepancies and missing information.

What Are the ALCOA+ Principles?

ALCOA+ provides a framework for evaluating the reliability of regulated records. It covers nine attributes: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. These principles apply across the data lifecycle.

• Attributable: Identify who performed the activity or generated the information.
• Legible: Keep records readable and understandable.
• Contemporaneous: Record information when the activity occurs.
• Original: Preserve the original record or an appropriately verified true copy.
• Accurate: Ensure information correctly represents the activity or result.
• Complete: Retain the information needed to understand and reconstruct the activity.
• Consistent: Maintain logical sequencing and coherent dates, times, and related records.
• Enduring: Preserve records in a durable form throughout retention.
• Available: Make records retrievable when needed.

MHRA’s GxP data integrity guidance

Good Documentation Practice for Paper Records

Paper records need controls for issuing forms, recording activities, making corrections, and retaining completed documents. Use current authorized forms and follow your organization’s approved documentation procedure.

Record Activities When They Occur

Enter information when the activity is performed or observed. Record results clearly, identify the person responsible, and include relevant dates, times, and units. Handle unused fields according to your procedure so reviewers can distinguish “not applicable” from missing information.

Keep Corrections and Late Entries Transparent

When correcting an entry, preserve the original information and identify the correction, its author, and its date. Include an explanation where required by your procedure. Do not erase, obscure, or backdate entries.

If information was not recorded when expected, follow the approved late-entry process. State the actual entry date, explain the delay, and identify the supporting evidence. Do not invent missing results or reconstruct them from unsupported assumptions.

Good Documentation Practice for Electronic Records

Electronic records need controls that preserve their meaning, traceability, and accessibility. Assess the system’s intended use, the information it generates, and the risks of unauthorized alteration, deletion, or loss.

Assign Appropriate User Access

Use individual accounts where actions need to be attributed to a person. Assign permissions according to responsibilities, review access periodically, and remove access when it is no longer needed. Restrict administrative privileges appropriately.

Preserve Relevant Data and Change History

Identify the electronic information needed to reconstruct an activity, including relevant source data, metadata, and change history. A printed summary may not preserve everything needed to understand how a result was generated or processed.

Verify Record Retrieval and Recovery

Check that retained records remain readable and retrievable throughout their required retention period. Establish backup and recovery arrangements appropriate to the records, and test restoration rather than assuming that a successful backup guarantees recovery.

Control Spreadsheets Used for GxP Activities

Spreadsheets can support calculations, tracking, and reporting, but their controls should reflect their intended use and potential impact. A spreadsheet used to make a product-quality decision needs different consideration from one used for informal planning.

Protect Formulas and Verify Calculations

Identify important formulas, input fields, and outputs. Check calculations against defined expected results, control changes to the approved version, and restrict editing where appropriate. Include checks for incorrect inputs and unexpected results.

Define Ownership and Record Retention

Assign an owner, maintain version identification, and define where approved files and completed records are stored. Evaluate access permissions, change traceability, backup, and retrieval. Worksheet protection alone does not establish adequate control for every GxP use.

Investigate Documentation Errors and Data Integrity Concerns

A missing entry or inconsistent timestamp does not automatically establish intentional misconduct. However, it should not be dismissed without evaluating the affected records, supporting evidence, and potential consequences.

Determine the Scope and Impact

Identify which activities, records, systems, and decisions may be affected. Preserve relevant evidence and assess whether the information remains reliable. Escalate concerns through the appropriate quality process, including evaluation of potential product impact.

Address the Cause and Verify Improvement

Investigate contributing factors such as unclear procedures, poor form design, workload, training gaps, or inappropriate system permissions. Select corrective actions based on the findings, then check whether they reduced recurrence. Do not create unsupported entries simply to make an incomplete record appear complete.

Good Documentation Practice Checklist

Use this checklist to review documentation practices in your organization. Adapt it to the records, systems, and requirements applicable to your activities.

• Are current, authorized forms and procedures available?
• Can records be attributed to the people performing the work?
• Are entries clear and recorded when activities occur?
• Are original information and relevant supporting data preserved?
• Are corrections and late entries transparent?
• Are unexplained blanks and discrepancies investigated?
• Are electronic permissions appropriate to each user’s responsibilities?
• Are relevant changes traceable and reviewed?
• Are spreadsheet calculations and revisions controlled?
• Are records retained, protected, and retrievable?
• Have backup restoration and record readability been checked?
• Are recurring problems addressed and improvements verified?

Frequently Asked Questions About Good Documentation Practice

Does GDocP Apply to Both Paper and Electronic Records?

Yes. Both formats need controls that support accurate recording, traceability, appropriate corrections, retention, and retrieval. Electronic records also require consideration of system access, configuration, and preservation of relevant electronic information.

How Should a Missing Entry Be Handled?

Follow the approved procedure for missing information and late entries. Identify the actual entry date, explain the circumstances, and use reliable supporting evidence where available. Do not backdate an entry or invent a result.

Does Moving to an Electronic System Guarantee Data Integrity?

No. Reliable electronic records depend on suitable system controls, appropriate configuration, trained personnel, and effective oversight. Replacing paper with software does not resolve every documentation weakness.

FDA Guidance on Data Integrity in Drug Manufacturing

FDA’s final guidance, Data Integrity and Compliance With Drug CGMP: Questions and Answers, explains the role of data integrity in drug manufacturing, including biologics. FDA expects reliable, accurate data and encourages meaningful, risk-based strategies to prevent and detect integrity problems.

Use the guidance alongside the regulations applicable to your operations. Evaluate where information could be altered, omitted, deleted, or lost, then establish controls suited to the process and its risks.

Strengthen Good Documentation Practice Across Your Organization

Trustworthy records depend on clear procedures, appropriate system controls, trained employees, and effective review. Good Documentation Practice should be part of daily operations, from the first entry through retention and retrieval.

Start by reviewing one frequently used record. Can you identify who performed the activity, understand the original result, trace corrections, and retrieve the supporting information? Use any gaps to improve the process and verify that the changes work.

Contact Qualcy to discuss your organization’s needs for controlled documentation, training records, investigations, and related quality processes.

Reliable records depend on controlled procedures and forms. Read our guide to common document change control issues and practical solutions.