Records

A Record is historical documentation retained to demonstrate that mandatory procedures have been followed, requirements have been met, and management objectives have been achieved, ensuring traceability and legal compliance. Forms are the blank templates filled in with information that become records.

The term Records in the context of manufacturing (often referred to as Quality Records) refers to documented information that provides evidence of activities performed, results achieved, and the overall conformity of a process or product to specified requirements. Records are the factual proof within the Quality Management System (QMS).

Records are the lowest level of documentation in the traditional QMS hierarchy. They are crucial because they transform subjective "quality" into objective, quantitative data suitable for measurement, comparison, and analysis. In regulated industries, the FDA mandates specific records for almost every major quality activity.

The Role of Records in the QMS

Records serve as the essential evidence that the QMS is functional and compliant:

Evidence of Conformity: Records are used to prove that requirements have been met. They demonstrate that processes and activities have been conducted in the way prescribed by procedures and work instructions.

Continuous Improvement Input: The QMS relies on records, such as quality records and quality audit reports, as sources of data to identify existing and potential causes of nonconforming product or other quality problems [127(a)].

Documentation Hierarchy: Records and forms sit at the base of the QMS documentation hierarchy, beneath the Quality Manual, procedures, and work instructions.

General Requirements for Record Management (QSR/QMSR)

The FDA's Quality System Regulation (QSR), and the superseding Quality Management System Regulation (QMSR), establish stringent controls over how records must be handled:

• Accessibility and Location: All records must be maintained at the manufacturing establishment or another location that is reasonably accessible to responsible officials and FDA employees designated for inspections. Records must be readily available for review and copying by FDA employees. For records held off-site (including electronic records), accessibility must be easy, sometimes within 2 working days or even 24 hours (e.g., during FDA investigations).
• Integrity: Records must be legible and stored to minimize deterioration and prevent loss. Those stored in automated data processing systems must be backed up.
• Confidentiality: Records deemed confidential by the manufacturer may be marked to assist the FDA in determining whether the information may be disclosed under public information regulations (21 CFR Part 20) [133, 151(d)].
• Control Procedure: Organizations must develop a procedure to control their records.

Record Retention Periods

Retention periods for records vary based on the type of record and the device lifecycle:

General QMS Records:

Records required by the QSR (Part 820) must be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution [133(b)].

MDR Event Files (Manufacturers/Importers):

Records relating to an adverse event must be retained for a period of 2 years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater [52(c)].

Corrections and Removals (Non-Reportable):

Manufacturers or importers must retain records of non-reportable corrections and removals for a period of 2 years beyond the expected life of the device [64(c)].

HCT/P Records:

Records pertaining to a particular Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) must be retained for at least 10 years after the date of administration, distribution, disposition, or expiration, whichever is latest [321(d), 309(4)].

Tracked Devices:

Records related to tracked devices must be maintained for the useful life of each tracked device.

Tobacco Products:

Records supporting substantial equivalence (SE) reports or postmarket applications must generally be retained for 4 years from the date of the FDA order or report submission [276, 288(i), 288(ii)].

Critical Types of Records

FDA regulations define specific types of required records essential for device traceability and manufacturing control (Part 820, Subpart M):

Device Master Record (DMR)

A compilation of records containing the procedures and specifications for a finished device [106(j), 135]. It includes device specifications (drawings, components, software), production process specifications, quality assurance procedures (acceptance criteria), packaging/labeling specifications, and installation/servicing procedures.

Device History Record (DHR)

A compilation of records containing the production history of a finished device [106(i), 136]. It demonstrates that a batch, lot, or unit was manufactured in accordance with the DMR. The DHR must include dates of manufacture, quantity manufactured/released, acceptance records (which demonstrate conformity with the DMR) [137(d), 126], primary label identification, and Unique Device Identifier (UDI) or control numbers [137(e), 137(f)].

Design History File (DHF)

A compilation of records which describes the design history of a finished device. Manufacturers must establish and maintain a DHF for each device type to demonstrate that the design was developed in accordance with the Design Plan and QMS requirements.

Quality System Record (QSR)

Includes, or refers to, procedures and documentation of activities required by the regulation that are not specific to a particular type of device (e.g., Management Review results, Quality Audit procedures, etc.).

Complaint Files

Manufacturers must establish and maintain procedures for receiving, reviewing, and evaluating complaints in a formally designated unit [138(a)]. The complaint file must record the nature and details of the complaint, the investigation results, and any corrective action taken.

Records in CAPA and Audits

Records are the objective evidence required for the CAPA process and audit preparedness:

CAPA Documentation: All activities required under the Corrective and Preventive Action (CAPA) section, along with their results, must be documented [129(b), 12(a)]. Any procedural changes needed to correct quality problems must be recorded [12, 128(5)].

Audit Readiness: A well-documented CAPA process ensures audit readiness and facilitates regulatory inspections. Audits themselves produce records; the dates and results of quality audits and reaudits must be documented.

MDR Documentation: Written procedures for Medical Device Reporting (MDR) must include documentation and record-keeping requirements for information evaluated to determine if an event was reportable, and all reports submitted [50(b)]. Manufacturers may maintain MDR event files as part of their complaint file, but they must be clearly identified as MDR reportable events.

Analogy for Understanding Records

If the entire Quality Management System (QMS) is a company's internal library, the Quality Policy is the library's main mission statement, and the Procedures are the detailed user guides for finding and processing information. A Record is the checkout slip.

The checkout slip (Record) proves that a book (Material/Component) was handled at a specific time (Date Shipped), by whom (Designated Individual's Signature), and confirms its conformity (Acceptance Records). The FDA doesn't just want to see the library's mission statement; they want to see every single checkout slip (DHR, Acceptance Records) to prove that the library's procedures were followed for every book ever released.

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