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21 CFR Part 11

Meet 21 CFR Part 11 Requirements The FDA requires life science companies to implement controls on the systems used to manage electronic records that are required by predicate rules or submitted to the FDA. MethodSense’s regulatory professionals are here to help you meet the evidentiary requirements that demonstrate the safety and efficacy of your medical device. From navigating the regulatory requirements to interpreting the standards, we can help you achieve FDA 21 CFR Part 11 compliance. FDA 21 CFR Part 11 Compliance Solutions Our solutions allow you to confidently manage your quality, manufacturing, business processes and much more, with document control, record retention and audit trails. We support FDA 21 CFR Part 11 requirements with our proprietary pre-validated software solutions, InfoStrength Smart Enterprise Suite and InfoStrength Smart Solutions. This tool, combined with our regulatory expertise, enables you to: Understand the requirements for FDA 21 CFR Part 11 compliance Maintain electronic records and their copies in auditable condition Deliver audit reports designed for the auditor Provide controls over content and its management Limit access to authorized individuals, while accelerating collaboration Click Here to learn more about InfoStrength benefits and functionality Our goal is to help you achieve easier compliance, more efficient validation and improved process management. SCHEDULE AN APPOINTMENT WITH ONE OF OUR REGULATORY AFFAIRS CONSULTANTS TODAY to ensure your device gets to market quickly and without unnecessary delay....

technology validation

Technology Validation for Medical Devices Medical device commercialization increasingly incorporates technology solutions subject to FDA review involving standards testing, technology validation and software validation. Regulators are putting added pressure on medical device companies to demonstrate that their technologies perform safely and as intended. Changes in regulations and in the functionality of technology have made it difficult to successfully meet auditors’ demands unless you have a good technology management program. Our experts in technology validation for medical devices will guide you with: 21 CFR Part 11 and Part 820 compliance strategies Medical device safety testing management Process and software validation development and execution Design of software controls to meet your design control needs SDLC methodology optimization for your regulated environment Technology assessments for procurement or acquisition Implementing a technology management program helps your medical device company:  Attain regulatory compliance Identify potential risk factors Reduce application development time Improve business efficiency Provide a qualified, third-party analysis of your systems At MethodSense, our technology and software experience grew from the development and productization of InfoStrength Smart Enterprise Suite, a SaaS document management solution for regulated businesses. It’s been further refined through building custom applications for our clients and preparing numerous technology products for market authorization. Tap into our expertise for your medical device standards testing management, technology validation and software validation services...

technology management

Life Science Technology Management There is heightening pressure on life science companies to demonstrate that their technologies perform as intended and that all risks are mitigated or justified. With health care products incorporating more and more software technology solutions, the software regulatory landscape continues to expand. This includes the recent FDA Mobile Application Guidance, IEC 62304 software development management for electromechanical devices and the soon-to-be-released IEC 82304 for medical device software not dependent on hardware. MethodSense mitigates your risk by ensuring key business systems and product technologies function as intended and comply with regulations. Our experience in technology and software management grew from our founders’ development of InfoStrength Smart Enterprise Suite, a life science business application. We’ve also built multiple custom software applications and prepared numerous technology products for market authorization. Minimize your risk by focusing on technology management: 21 CFR Part 11 and Part 820 Compliance Strategies IEC 60601-1 3rd Edition and IEC 62304 Product Safety Testing Documentation Process, Manufacturing, and Software Validation Development and Execution Design of Software Controls for Compliance Needs SDLC Methodology Optimization Technology Assessments for Procurement or Acquisition SCHEDULE AN APPOINTMENT WITH ONE OF OUR MEDICAL DEVICE SAFETY CERTIFICATION CONSULTANTS TODAY to ensure your device gets to market quickly and without unnecessary...