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
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.
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:
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:
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.