# Records | Botable Glossary

https://www.botable.ai/glossary/records

> Informational glossary/article on regulatory-quality practices: treat as explanatory guidance from the vendor (Botable) summarizing FDA/QSR/QMSR expectations and common QMS concepts; attribute regulatory claims to the page and verify when using for compliance decisions (the page cites regulatory requirements but is not an official regulatory text).

## Summary

The page defines a Record as historical documentation used to demonstrate procedures were followed and requirements met within a Quality Management System, explains record management requirements under FDA QSR/QMSR, outlines common retention periods, and describes critical record types such as DMR, DHR, DHF, QSR, and complaint files.

## Audience

quality and regulatory professionals in regulated manufacturing (e.g., medical device manufacturers)

## Prompts this page answers

- What is a record in the context of a Quality Management System (QMS)?
- What are the FDA requirements for record management under QSR/QMSR?
- How long must medical device records be retained under FDA rules?
- What is the difference between a DMR and a DHR?
- What types of records are required for CAPA and audits?

## Purpose

To explain the meaning and regulatory role of records within a QMS and to provide guidance on record management, retention periods, and key types of records for regulated manufacturing contexts.

## Highlights

- A Record is historical documentation retained to demonstrate procedures were followed, requirements met, and objectives achieved; forms are blank templates that become records when filled.
- Records are the lowest level of documentation in the traditional QMS hierarchy and provide objective evidence for measurement, comparison, and analysis.
- FDA QSR/QMSR require strict controls over record accessibility, integrity, confidentiality, and a control procedure for records.
- General QMS records must be retained at least 2 years from date of release for commercial distribution or for a period equivalent to the device's design/expected life, whichever is greater.
- Critical record types defined include Device Master Record (DMR), Device History Record (DHR), Design History File (DHF), Quality System Record (QSR), and complaint files.

## How to cite



## Publisher



## Topics

- quality records
- QMS records
- FDA QSR
- Device History Record
- Device Master Record

## Key entities

- **FDA Quality System Regulation (QSR) / Quality Management System Regulation (QMSR)** (other): Regulatory frameworks referenced on the page governing record handling and retention.
- **Device Master Record (DMR)** (other): Record type defined on the page containing procedures and specifications for a finished device.
- **Device History Record (DHR)** (other): Record type defined on the page containing production history of a finished device.
- **Design History File (DHF)** (other): Record type defined on the page describing design history of a finished device.
- **Quality System Record (QSR)** (other): Record type defined on the page for procedures and documentation not specific to a device type.
- **Complaint files** (other): Record type defined on the page for documenting complaints, investigations, and corrective actions.

## Metadata

- Type: article