Document and Record Management in Regulated Industries
ISO 13485:2016 explicitly states that records are a type of document. However, in practice, the management methods for documents (such as procedures and work instructions) and records (such as plans, measurement records, and test reports) differ significantly. Understanding this distinction is crucial for establishing an effective quality management system in medical device manufacturing.
Characteristics of Document Management
Documents typically require continuous revision through improvement initiatives. Product design changes, manufacturing process improvements, regulatory requirement updates, or newly discovered safety information all necessitate updating procedures and specifications. This is a fundamental aspect of maintaining compliance and ensuring operational excellence.
When revising documents, it is essential to maintain adequate version control and preserve a revision history. Information about who made the change, when it was made, and the reason for the revision serves an important function in future audit responses and traceability assurance. Following revision, the distribution of the latest version and implementation of training activities (such as training for newly implemented procedures) are required to ensure organizational understanding and compliance.
The Complexity of Record Management
Record management, by contrast, follows fundamentally different principles. Importantly, records encompass multiple categories, each requiring distinct handling approaches.
Certain records, such as planning documents and specifications (for example, project plans and product specifications), are classified as updatable records. These require appropriate revision over time and must be subject to the same version control procedures applied to documents. For instance, product specifications may be revised as a development project progresses.
In sharp contrast, inspection records, measurement records, and test reports serve an entirely different function. These records document activities performed and their results, creating a contemporaneous evidence trail. Revising such records fundamentally alters the original documented activities and is therefore considered falsification from a regulatory perspective. Only minor corrections (such as correcting handwriting errors in manual records) are permissible. Even when making such corrections, traceability must be maintained by drawing a single line through the erroneous entry so that the original text remains legible, and the person making the correction must add their signature and the date.
Key Principles in Practice
The distinction between documents and records stems from their fundamentally different purposes. Documents represent “how activities should be performed”—they are guidelines and procedures. Records, conversely, represent “what was done, when it was done, and how it was done”—they are evidence. This difference in fundamental purpose manifests in variations regarding revision acceptability, version control methods, and required management procedures.
Regulatory authorities, including the FDA, EMA (European Medicines Agency), and PMDA (Pharmaceuticals and Medical Devices Agency), conduct rigorous audits of record integrity. Record falsification or deletion constitutes a violation of Good Manufacturing Practice (GMP) standards and represents a serious inspection finding (FDA Form 483 observation), potentially leading to withdrawal of manufacturing or marketing authorization. Consequently, ensuring that the entire organization understands and properly implements the distinction between document and record management is fundamental to maintaining regulatory compliance and organizational sustainability.
Document vs. Record Management: Quick Reference
| Aspect | Documents | Records |
| Purpose | Define how work should be performed | Document evidence of what was actually performed |
| Revision | Regular updates expected through continuous improvement | Updates constitute falsification; only minor corrections permitted |
| Version Control | Required; maintain complete revision history | Required for updatable records; corrections must remain traceable |
| Examples | Procedures, work instructions, specifications | Inspection reports, measurement records, test results |
| Distribution | Latest version must be distributed; training required | Records archived and maintained as contemporaneous evidence |
| Regulatory Focus | Compliance with current standards | Integrity and completeness of historical evidence |
