GLOSSARY

Document Control SOP

Definition

A document control SOP is authored by a medical device company to comply with the FDA's quality system regulations for document control, found in 21 CFR Part 820.40.

Whether your medical device company wishes to comply with the FDA quality system regulations or the ISO 13485 quality standard, you will have to meet strict document control requirements as part of your compliance efforts. The first and most important requirement set by the FDA in 21 CFR Part 820.40 is that medical device companies must establish and maintain a procedure for controlling documents in accordance with the requirements.

An SOP, or Standard Operating Procedure, is a set of listed instructions that describes how the organization accomplishes a specific task or meets specific requirements. In manufacturing, SOPs are used for a great variety of activities. There are SOPs for completing steps in the manufacturing process, how to transport and store product, how to report a problem or failure, when and how to initiate a CAPA, and any other operations that the company does on a routine basis.

A document control SOP is just one of many SOPs that medical device companies use to control their operations. This document establishes the roles and responsibilities, procedures, and checks that will lead to an effective and compliant document control process.

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The Role of SOPs In Medical Device Companies?

SOPs play an important role in overall quality at medical device companies. When an organization creates an SOP, they are introducing standardization, predictability, and quality into a process. SOPs ensure that routine tasks are done the exact same way all the time, creating a repeatable process that can be iterated and improved upon. SOPs are also used to assign responsibilities for tasks to certain parties, and they can be updated as an organization learns more about how to increase the efficiency of its most important routine tasks.

Medical device companies who wish to sell their devices in the United States should author a document control SOP that promotes compliance with the requirements of the FDA. These include:

Document Approval - A manufacturer must assign someone to review and approve all quality system documents with signature and date.
Document Distribution - Documents in the QMS must be made available everywhere they are used or otherwise necessary.
Document Removal - Obsolete documents must be promptly removed from all points of use and prevented from unintended use.
Document Changes - Document changes must be reviewed and approved by someone in the same function or organization that completed the initial review. Manufacturers must maintain records of document changes, including a description of the change, what documents were affected, the signature, approval date and when the change becomes effective.

What's in a Document Control SOP?

A document control SOP defines the procedure that the medical device company will use to meet the document control requirements of ISO and the FDA. It may include:

Purpose and Scope - A short description of what the document is, how it will be used and what it is meant to cover or accomplish.
Roles and Responsibilities - The document control SOP should designate someone as responsible for approvals. It may assign other responsibilities too, for example, making operators responsible for reporting obsolete documents on the manufacturing floor.
Document Control Procedure - The document control SOP should describe the actual workflow and procedures that will be used to manage documents. Medical device companies are free to structure the process however they choose, but the end result must be compliant with legal requirements or relevant standards.

Greenlight Guru Makes It Easy To Manage Your Document Control SOP

Greenlight Guru offers the only electronic QMS platform that allows near zero effort validation with FDA’s 21 CFR Part 11 document control regulations. With Greenlight Guru, medical device companies can easily author, review, approve, distribute, change, re-approve and retire any documents in the software with the click of a button. Electronic signatures and date stamps streamline the approval process along with automated change records and reporting features. Greenlight Guru can help your medical device company comply with the FDA QSR, amplify your quality efforts to build a higher quality product and get you to market faster.

FREE DOWNLOAD: Click here to download the eBook PDF of our Ultimate Guide to Document Control for Medical Device Companies