Category: Medical Device

Maintain document control.

Medical device document management and control is essential for an effective quality management and regulatory compliant system, especially as your product pipeline expands toward commercialization goals. To meet these challenges head on, it’s vital to manage information across your entire operation, ensuring regulatory compliance including: FDA 21 CFR Part 11 regulations; ISO quality standards; Sarbanes-Oxley Act requirements; and other regulations.

What are some of the key elements of a central repository for all your critical business information? Your document management system must allow you to:

  • Create a searchable library of business and regulatory documents.
  • Organize and control critical content.
  • Demonstrate authenticity and non-repudiation.
  • Improve communication and teamwork across departments and teams.
  • Lower the cost of FDA regulatory compliance with electronic documents, e-signatures, version control, audit trails, and the ability to manage permissions to critical content.

The document management solution from LuminLogic has been successfully validated and inspected in FDA environments. We’ve helps companies like yours dramatically reduce the time it takes to bring a new product to market by accelerating the process for document change, approval, notification and distribution. Our easily configurable Software as a Service (SaaS) tool is designed for rapid implementation and validation, and we offer on-call Quality Support services to ensure your medical device or pharmaceutical QMS remains compliant.

Want to learn more? Contact the regulatory document specialists at LuminLogic today.

What’s the right Quality Management System software?

The medical device industry is a highly regulated environment that requires a stringent adherence to quality. So, you need a QMS software that helps you manage the project process to enhance team collaboration, reduce time to market, and manage critical information that can be immediately accessed.

But with so many QMS software options in the global market, how do you choose the one that’s best for your specific medical device needs? Here’s a helpful checklist to consider.

Research regulatory requirements that apply to your medical device. 

Ensure that you have a strong grasp of the regulations and certifications applicable to your device and country. Your QMS software features and quality processes should be designed around these regulations to ensure a culture of compliance in safety across your organization.

Your QMS software needs to be priced for purpose. 

Use a checklist to determine the key purposes the QMS will serve and who will use it. This will help you decide if the QMS software needs to be feature-packed and modern or relatively inexpensive.

Know the software’s limitations

QMS software contributes to increased quality and cost savings, but it does have its shortcomings. Be sure the software must be easy to implement and customize when needed. It should also be user-friendly and require less maintenance and upgrades while being stable and secure.

Figure out the resources. 

Read reviews of the ISO 13485 Quality Management System or ask for case studies to understand its timing and resources. The software must be capable of identifying common trends in complaints and failures on the production line. It should be able to streamline quality across all the key functions while maintaining compliance. It should facilitate effective resource utilization.

Choose a trusted partner with expertise. 

There are myriad companies worldwide offering QMS solutions ranging from cheap to expensive. Choose to reputable partner that is trusted in the industry. They must have proven experience in implementing and supporting QMS software for industries similar to yours, with a firm understanding of the standard regulatory and safety procedures. Their software will be pre-built with many compliance procedures that are common to your requirements.

Software for the medical device manufacturing industry is constantly advancing, so the ISO 13485 Quality Management System you choose must be designed for scalability and integration for the long run. If you’d like to learn more about Medical Device Quality Management System that works to support the regulated environment your business supports, we can help

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