MARKETS

Global Regulatory Compliance

Increasingly, business has become more and more regulated. Over the years, entire industries have seen dramatic growth in regulations affecting their operations including finance, government and the life sciences industries. While LuminLogic was designed with life sciences in mind, any business that functions best with secure quality Medical Device Document Management Software practices will benefit from our robust quality and regulatory management tool. LuminLogic helps businesses like yours:

  • Operate effectively without raising costs
  • Collaborate to foster innovation
  • Meet regulatory uncertainty head on
  • Eliminate cumbersome paper processes
  • Utilize interactive portals for sharing information

To learn more about how LuminLogic can support your business, contact us today.

Medical Devices
BioTech
Pharmaceutical

Medical Device Document Management Software

Moving your daily business operations to the “cloud” gives you the speed and flexibility you need to manage your business with precision. Bring your device to market more quickly and easily with LuminLogic’s powerful document, project and quality management tools. These tools set you up for successful communications with the FDA and global regulatory bodies, regardless of where you are in the commercialization process. Med device companies use LuminLogic to:

  • Prepare 510(k) submissions for FDA approval
  • Meet 21 CFR Part 820 standards for cGMP and QMS
  • Gain a competitive advantage by managing ISO Certification
  • Utilize a business software that maintains validation compliance
  • Manage IEC 60601-1 safety testing requirements

LuminLogic users also benefit from:

  • Access to experienced regulatory and quality management consultants
  • No infrastructure to set up or maintain
  • Customized solutions that can be configured in hours… not weeks
  • Real time visibility of all your projects with project and team reports
  • 360° view of key business processes
  • Improved collaboration for your employees and vendors
  • Hardware and hosted computing environment management

To learn more about how LuminLogic can support your business, contact us today.

BioTech Solutions

Forward-thinking biotech firms are moving their business operations from costly client-server technologies to cloud computing environments. They know the cloud gives them the speed, flexibility and scalability they need to succeed in this fast-paced world they live in. LuminLogic was designed specifically to meet the challenges of life science companies head on. Anytime, anywhere access to information allows your team to operate efficiently on a global scale. We manage the computing environment so you don’t have to. Biotechnology firms use LuminLogic to:

  • Manage documentation for regulatory affairs
  • Maintain GxP Documentation to meet global requirements
  • Gain a competitive advantage with ISO Certification
  • Utilize a business software that maintains validation compliance
  • Manage IEC 60601-1 safety testing requirements
  • Achieve and auditable standard of quality

LuminLogic users also benefit from:

  • Access to experienced regulatory and quality management consultants
  • No infrastructure to set up or maintain
  • Customized solutions that can be configured in hours… not weeks
  • Real time visibility of all your projects with project and team reports
  • 360° view of key business processes
  • Improved collaboration for your employees and vendors
  • Hardware and hosted computing environment management

To learn more about how LuminLogic can support your business, contact us today.

Pharmaceutical Solutions

Bringing a drug to market requires an unmatched level of detail and organization. Moving to a paperless environment gives your team the ability to collaborate, innovate and operate with speed and efficiency. LuminLogic was designed specifically to meet the challenges of life science companies head on with powerful document, project and quality management tools. These tools set you up for successful submissions to the FDA and global regulatory bodies, regardless of where you are in the commercialization process. Pharmaceutical companies use LuminLogic to:

  • Manage documentation to meet regulatory requirements
  • Prepare for internal and external audits
  • Maintain GxP Documentation to meet global requirements
  • Document risk management protocols
  • Utilize a business software that maintains validation compliance

LuminLogic users also benefit from:

  • Access to experienced regulatory and quality management consultants
  • No infrastructure to set up or maintain
  • Customized solutions that can be configured in hours… not weeks
  • Real time visibility of all your projects with project and team reports
  • 360° view of key business processes
  • Improved collaboration for your employees and vendors
  • Hardware and hosted computing environment management

To learn more about how LuminLogic can support your business, contact us today.

LUMIN LOGIC
Benefits of Medical Device Document Management Software
  • Quick Audits 

    Document Management software comes with version control features that adhere to audit compliance. Document version controls and archival are robust to ensure that the latest versions are available. It complies with audit requirements by bodies like the FDA or ISO. It makes preparing for an audit stress-free. It mitigates the risk of lapses during audits.

  • Avoid Losing Documents 

    Streamlined document archival and version control keep documents up-to-date and secure. Enabling document access to only key stakeholders makes keeping track of documents easy. The audit trail features built-in providing quick access to information about whom last checked out or modified a document. Electronic storage saves physical space, and documents are backed up regularly.

  • Increased Data Security 

    A major requirement for organizations is to safeguard their data as well as protect any customer information. A good QMS software is designed with data protection in mind and implements strong security protocols. It provides stringent controls over access to sensitive information. Data governance and compartmentalization can be closely monitored and customized.

  • Enhanced Regulatory Compliance 

    Certain documents essential for regulatory and compliance audits are complex in nature. These need to be scrutinized and stored as per regulations dictated by bodies like FDA and ISO. Non-compliance could lead to fines, license cancellations, and, in some cases, criminal proceedings. QMS software significantly reduces the risk of non-compliance owing to structured process flows.

  • Easier Retrieval 

    Electronic filing systems for documents within a QMS has multiple benefits. They help with easy storage and retrieval of documents from a secure repository. These systems monitor document access permissions and security persistently. The system indexes the documents for easy search and retrieval. It saves an organization plenty of time and reduces operational costs.

  • Safety of Documents 

    A medical device manufacturing company needs to store and maintain a large number of electronic documents. These often contain compliance certificates or confidential data about your products and employees. An important role of a QMS is to safeguard this data. It prevents unauthorized access and maintains a record of the people who have accessed them.

  • Be Stress-Free 

    A well-managed QMS software promotes a health culture of security and compliance. It can be stressful and a complex task to track thousands of documents without an effective file and quality management system. QMS software help with backing data, monitor file access and provide top-notch security. It ensures peace of mind and compliance.

  • Accessibility 

    Document Management Systems are always convenient and accessible. They play a major role in ensuring compliance and maintaining an ethical workforce. A company has unbridled access to all its data from any location. Information is formatted to be displayed on any device, regardless of its size. It enhances productivity and strengthens the manufacturing process.

  • Reduced Storage Space 

    QMS software formats large documents into compressed and encrypted files that are small in size. It translates into cost savings and takes storage space. You can save your files on a secure cloud service to save more space on your local storage devices. Importantly, they help do away with the need for physical storage of files.

  • Easily Multitask 

    Document Management System is designed to improve productivity by allowing multitasking. Different people across diverse functions can access the features of the QMS at the same time. The software is designed to be robust and stable during high volumes of data access. Many concurrent tasks ranging from monitoring errors to securing data, can be performed.

    Are you looking for an automated Document Management Software for Medical Devices? Then, get in touch with us now!

How Our software Became #1 Medical Device Document Management Software in The World?
  • We understand your needs 

    We build the world’s finest Medical device document management software. We do this so well from our extensive experience in understanding customer needs. We analyze our customer’s requirements and discuss their expectations from the software. We then meticulously plan and develop your software using Agile methodology. You are consulted during every phase of product development.

  • We deliver supremacy 

    Our Document Management System is built to specifications and adheres to the highest benchmarks in software development—every aspect of our product projects excellence in quality and stability. We work with the latest technology and tools to deliver world-class software. Our software suite meets global compliance and security requirements. It’s scalable and tailor-made to meet your needs.

  • Quick Response Time 

    Our support and engineering teams work round the clock to serve our clients. We are always available to discuss any issues with the software and help you troubleshoot a solution. Our experienced IT teams can remotely access your systems and fix most problems online. Our response and resolution time are the best in the industry.

  • High-Quality Service 

    We always embody a service mindset within our organization. Our teams are customer-focused and strive to understand and exceed customer expectations. We never compromise on quality and work on any inputs and product feedback from our clients. We follow Agile principles to build software secure, reliable, and quality Document Management System.

    Reach us to know why we are #1 in delivering a Document Management System for Medical Devices.

Sign Up for a Free Demo

Connect with one of our regulatory software experts to get a live demo of Methodsense’s LuminLogic in action. We’ll show you how easy it is to use, as well as how it works to support the regulated environment your business supports.

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