Quality
Standard operating procedures (SOPs) present a problem when it comes to getting them approved, updated, and distributed. Solve those problems by managing your medical device SOPs with an electronic quality management system (eQMS).
What is SOP in quality management?
SOP is the acronym for standard operating procedure. It is a group of documents that describe how things are done in a company. Common SOPs used in quality management include written instructions explaining how quality assurance and quality control procedures should be performed.
How do I write an SOP?
Writing an SOP is difficult if you’ve never done it before. That’s why we provide free SOP templates that you can download to guide you through the process. The template will explain what each section means and the information that needs to be included there. You can find these templates below in the Resources section.
Is SOP QA or QC?
Both quality assurance (QA) and quality control (QC) are involved in medical device SOPs. Depending on how responsibilities are divided at your company, QA might be responsible for creating and maintaining SOPs while QC might primarily use them as a reference.
Select the SOP Management resources you’d like to download.
SOP management is largely automated when you use advanced software that provides these features.
SOPs are consistently reviewed and updated. A common concern is ensuring that the most recent version is being used. MasterControl offers complete version control by letting you archive old versions and only allowing access to the most recent one.
Rather than combing through filing cabinets, SOP software enables you to type a few words into a search bar and quickly find what you’re looking for.
21 CFR Part 11 allows for the use of electronic signatures in regulated environments. This spares someone the trouble of physically tracking people down and getting them to sign a piece of paper.
SOPs frequently fall under the jurisdiction of the quality department, but there’s much more to quality than SOPs or even documents in general. The best SOP software is part of a larger eQMS.
MasterControl offers SOP management as part of our eQMS. With document control that gives you complete control over your SOPs, you can ensure they’re always up to date and audit ready.
Everything you need to know about MasterControl’s QMS and the benefits it offers.
Learn about other medical device companies that use MasterControl.
