QUALITY MANAGEMENT SYSTEM & REGULATORY COMPLIANCE The AssurX software platform is a highly versatile automated Quality Management System (QMS) and Regulatory Compliance Management Software used to improve quality and compliance, streamline workflow, control risk, and better manage any enterprise. Our QMS and Regulatory Compliance Management software puts quality at your enterprise’s COMPLETE AUTOMATED DOCUMENT MANAGEMENT SOFTWARE Document Management Software. AssurX’s document management software automates the storage and management of documents across the enterprise and throughout the document lifespan. The software provides collaboration tools to let you create, modify, review, and distribute documents in a controlled manner—all from a secure central

repository

5 QUALITY MANAGEMENT TRENDS TO WATCH IN 2021 SUPPLIER QUALITY MANAGEMENT SOFTWARE Extend quality across global supplier networks. AssurX Supplier Quality Management (SQM) helps your organization manage suppliers, vendors, contract manufacturers, and service providers with one solution designed to enforce your quality and compliance goals. Quickly detect, inspect, contain and drive action (s) to resolve

quality issues to

MANAGEMENT TEAM

TAMAR JUNE, PRESIDENT & CEO, is an entrepreneur who has mastered the balance of technology, team leadership, and customer-focused business throughout her career. Joining the two co-founders of AssurX in 2000, she helped grow the organization from a lean startup to hundreds of thousands of worldwide users in companies across various markets. FOOD AND BEVERAGE INDUSTRY QUALITY & COMPLIANCE MANAGEMENT Achieve the highest Food and Beverage quality and compliance while maintaining production efficiency and profitability. AssurX provides fast, detailed visibility and traceability of product quality and safety from the supply chain to the consumer and a means to easily comply with Food and Beverage industry regulatory standards from the FDA, USDA, HACCP, and others. HOW TO MEET NEW EU MDR REQUIREMENTS FOR VIGILANCE AND After a one-year delay due to concerns over a shortage of notified bodies, the new EU Medical Device Regulation (MDR) is set to take effect as of May 26, 2021. The regulations are a departure from the prior Medical Device Directive (MDD), which once made the EU an easier place to introduce products compared with more stringent FDA

requirements.

5 PILLARS OF MODERN ENTERPRISE QUALITY MANAGEMENT SYSTEMS These five attributes are not only powerful building blocks of effective enterprise quality management systems, but they are also industry agnostic. Pillar 1: Process Integration. While most companies execute on these functions, the degree of integration and automation varies greatly from company to company. WEAK CAPA PROGRAMS HIT GLOBALLY BY FDA WARNINGS Weak CAPA programs will continue to be a recurring theme in FDA warning letters. No matter where an issue arises, automated corrective and preventive action software like AssurX can isolate an issue as its arises and assist in swiftly managing its resolution. 9 BENEFITS OF A SUPPLIER SCORECARD Title: 9 Benefits of a Supplier Scorecard Author: AssurX Subject: Enterprise quality management system (EQMS), manufacturers can use the supplier scorecard to mitigate risk, benchmark vendors, and manage supplier performance. QUALITY MANAGEMENT SYSTEM & REGULATORY COMPLIANCE The AssurX software platform is a highly versatile automated Quality Management System (QMS) and Regulatory Compliance Management Software used to improve quality and compliance, streamline workflow, control risk, and better manage any enterprise. Our QMS and Regulatory Compliance Management software puts quality at your enterprise’s COMPLETE AUTOMATED DOCUMENT MANAGEMENT SOFTWARE Document Management Software. AssurX’s document management software automates the storage and management of documents across the enterprise and throughout the document lifespan. The software provides collaboration tools to let you create, modify, review, and distribute documents in a controlled manner—all from a secure central

repository

5 QUALITY MANAGEMENT TRENDS TO WATCH IN 2021 SUPPLIER QUALITY MANAGEMENT SOFTWARE Extend quality across global supplier networks. AssurX Supplier Quality Management (SQM) helps your organization manage suppliers, vendors, contract manufacturers, and service providers with one solution designed to enforce your quality and compliance goals. Quickly detect, inspect, contain and drive action (s) to resolve

quality issues to

MANAGEMENT TEAM

TAMAR JUNE, PRESIDENT & CEO, is an entrepreneur who has mastered the balance of technology, team leadership, and customer-focused business throughout her career. Joining the two co-founders of AssurX in 2000, she helped grow the organization from a lean startup to hundreds of thousands of worldwide users in companies across various markets. FOOD AND BEVERAGE INDUSTRY QUALITY & COMPLIANCE MANAGEMENT Achieve the highest Food and Beverage quality and compliance while maintaining production efficiency and profitability. AssurX provides fast, detailed visibility and traceability of product quality and safety from the supply chain to the consumer and a means to easily comply with Food and Beverage industry regulatory standards from the FDA, USDA, HACCP, and others. HOW TO MEET NEW EU MDR REQUIREMENTS FOR VIGILANCE AND After a one-year delay due to concerns over a shortage of notified bodies, the new EU Medical Device Regulation (MDR) is set to take effect as of May 26, 2021. The regulations are a departure from the prior Medical Device Directive (MDD), which once made the EU an easier place to introduce products compared with more stringent FDA

requirements.

5 PILLARS OF MODERN ENTERPRISE QUALITY MANAGEMENT SYSTEMS These five attributes are not only powerful building blocks of effective enterprise quality management systems, but they are also industry agnostic. Pillar 1: Process Integration. While most companies execute on these functions, the degree of integration and automation varies greatly from company to company. WEAK CAPA PROGRAMS HIT GLOBALLY BY FDA WARNINGS Weak CAPA programs will continue to be a recurring theme in FDA warning letters. No matter where an issue arises, automated corrective and preventive action software like AssurX can isolate an issue as its arises and assist in swiftly managing its resolution. 9 BENEFITS OF A SUPPLIER SCORECARD Title: 9 Benefits of a Supplier Scorecard Author: AssurX Subject: Enterprise quality management system (EQMS), manufacturers can use the supplier scorecard to mitigate risk, benchmark vendors, and manage supplier performance. COMPLIANCE MANAGEMENT SOFTWARE AssurX compliance management software automates the tracking and control of compliance-related activities—from documentation to planning, scheduling, reporting, mitigation, and audit for the enterprise. Assurx offers a versatile, closed-loop system that helps you consistently measure, demonstrate, and sustain compliance for an

array of

TRAINING MANAGEMENT SOFTWARE AssurX Training Management software ensures your personnel is always effectively prepared for the job. All training history is properly documented, accessible, and auditable to meet quality management and regulatory compliance requirements. Take charge of all training requirements, activities, materials/courses, and histories throughout

your

COMPLETE AUTOMATED DOCUMENT MANAGEMENT SOFTWARE Document Management Software. AssurX’s document management software automates the storage and management of documents across the enterprise and throughout the document lifespan. The software provides collaboration tools to let you create, modify, review, and distribute documents in a controlled manner—all from a secure central

repository

SUPPLIER QUALITY MANAGEMENT SOFTWARE Extend quality across global supplier networks. AssurX Supplier Quality Management (SQM) helps your organization manage suppliers, vendors, contract manufacturers, and service providers with one solution designed to enforce your quality and compliance goals. Quickly detect, inspect, contain and drive action (s) to resolve

quality issues to

MANAGEMENT TEAM

TAMAR JUNE, PRESIDENT & CEO, is an entrepreneur who has mastered the balance of technology, team leadership, and customer-focused business throughout her career. Joining the two co-founders of AssurX in 2000, she helped grow the organization from a lean startup to hundreds of thousands of worldwide users in companies across various markets. CHANGE CONTROL MANAGEMENT SOFTWARE Change Control Management Software. Orchestrate, track, and document changes across your business with AssurX Change Control Management software. Our automated change control software provides a compliant method to help your organization manage any change. The software takes change requests and manages the evaluation, planning, approval ENERGY AND UTILITIES INDUSTRY SOLUTIONS AssurX provides an end-to-end, automated NERC compliance software solution that expands seamlessly to address all Energy & Utilities industry regulations. One enterprise-wide, flexible system consistently manages operations, identifies risks, and demonstrates compliance across all critical operations. Learn about the AssurX

system for Energy

BEST PRACTICES FOR 21 CFR PART 11 COMPLIANCE The EQMS helps to ensure that compliance with Part 11 best practices is met while saving time, reducing the risk of errors and ensuring documented audit trails and electronic signature compliance. AssurX Quality + Compliance A single versatile software system can improve quality, compliance and streamline workflow. THE FDA'S FAST TRACK MODEL FOR SAMD PRECERTIFICATION Want to be part of FDA’s SaMD precertification program?Get your quality management system up to par. Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies. FDA WARNING LETTERS EMPHASIZE DOCUMENT CONTROL SYSTEM First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. Both highlight the vital importance of documenting evidence and risk management activities to maintain compliance with FDA guidelines. QUALITY MANAGEMENT SYSTEM & REGULATORY COMPLIANCE The AssurX software platform is a highly versatile automated Quality Management System (QMS) and Regulatory Compliance Management Software used to improve quality and compliance, streamline workflow, control risk, and better manage any enterprise. Our QMS and Regulatory Compliance Management software puts quality at your enterprise’s COMPLIANCE MANAGEMENT SOFTWARE AssurX compliance management software automates the tracking and control of compliance-related activities—from documentation to planning, scheduling, reporting, mitigation, and audit for the enterprise. Assurx offers a versatile, closed-loop system that helps you consistently measure, demonstrate, and sustain compliance for an

array of

FOOD AND BEVERAGE INDUSTRY QUALITY & COMPLIANCE MANAGEMENT Achieve the highest Food and Beverage quality and compliance while maintaining production efficiency and profitability. AssurX provides fast, detailed visibility and traceability of product quality and safety from the supply chain to the consumer and a means to easily comply with Food and Beverage industry regulatory standards from the FDA, USDA, HACCP, and others.

MANAGEMENT TEAM

TAMAR JUNE, PRESIDENT & CEO, is an entrepreneur who has mastered the balance of technology, team leadership, and customer-focused business throughout her career. Joining the two co-founders of AssurX in 2000, she helped grow the organization from a lean startup to hundreds of thousands of worldwide users in companies across various markets. 5 QUALITY MANAGEMENT TRENDS TO WATCH IN 2021 HOW TO MEET NEW EU MDR REQUIREMENTS FOR VIGILANCE AND The new EU MDR significantly strengthens requirements around post-market vigilance and reporting, two areas where MDD requirements were relatively light. The new regulation incorporates the principles of ISO 13485 for medical devices and ISO 14971 for medical device risk management, applying them to the entire manufacturing process. While

EU

5 PILLARS OF MODERN ENTERPRISE QUALITY MANAGEMENT SYSTEMS These five attributes are not only powerful building blocks of effective enterprise quality management systems, but they are also industry agnostic. Pillar 1: Process Integration. While most companies execute on these functions, the degree of integration and automation varies greatly from company to company. SUCCESSFUL QMS IMPLEMENTATION REQUIRES CLEARLY DEFINEDSEE MORE ON

ASSURX.COM

9 BENEFITS OF A SUPPLIER SCORECARD Title: 9 Benefits of a Supplier Scorecard Author: AssurX Subject: Enterprise quality management system (EQMS), manufacturers can use the supplier scorecard to mitigate risk, benchmark vendors, and manage supplier performance. WEAK CAPA PROGRAMS HIT GLOBALLY BY FDA WARNINGS The good news is that taking a look at FDA inspection patterns can help medical device manufacturers proactively assess and improve their own programs. In a June 30 warning letter, the agency zeroed in on the CAPA program at TriMed, Incorporated, a manufacturer of implantable bone fixation systems in Santa Clarita, California. QUALITY MANAGEMENT SYSTEM & REGULATORY COMPLIANCE The AssurX software platform is a highly versatile automated Quality Management System (QMS) and Regulatory Compliance Management Software used to improve quality and compliance, streamline workflow, control risk, and better manage any enterprise. Our QMS and Regulatory Compliance Management software puts quality at your enterprise’s COMPLIANCE MANAGEMENT SOFTWARE AssurX compliance management software automates the tracking and control of compliance-related activities—from documentation to planning, scheduling, reporting, mitigation, and audit for the enterprise. Assurx offers a versatile, closed-loop system that helps you consistently measure, demonstrate, and sustain compliance for an

array of

FOOD AND BEVERAGE INDUSTRY QUALITY & COMPLIANCE MANAGEMENT Achieve the highest Food and Beverage quality and compliance while maintaining production efficiency and profitability. AssurX provides fast, detailed visibility and traceability of product quality and safety from the supply chain to the consumer and a means to easily comply with Food and Beverage industry regulatory standards from the FDA, USDA, HACCP, and others.

MANAGEMENT TEAM

TAMAR JUNE, PRESIDENT & CEO, is an entrepreneur who has mastered the balance of technology, team leadership, and customer-focused business throughout her career. Joining the two co-founders of AssurX in 2000, she helped grow the organization from a lean startup to hundreds of thousands of worldwide users in companies across various markets. 5 QUALITY MANAGEMENT TRENDS TO WATCH IN 2021 HOW TO MEET NEW EU MDR REQUIREMENTS FOR VIGILANCE AND The new EU MDR significantly strengthens requirements around post-market vigilance and reporting, two areas where MDD requirements were relatively light. The new regulation incorporates the principles of ISO 13485 for medical devices and ISO 14971 for medical device risk management, applying them to the entire manufacturing process. While

EU

5 PILLARS OF MODERN ENTERPRISE QUALITY MANAGEMENT SYSTEMS These five attributes are not only powerful building blocks of effective enterprise quality management systems, but they are also industry agnostic. Pillar 1: Process Integration. While most companies execute on these functions, the degree of integration and automation varies greatly from company to company. SUCCESSFUL QMS IMPLEMENTATION REQUIRES CLEARLY DEFINEDSEE MORE ON

ASSURX.COM

9 BENEFITS OF A SUPPLIER SCORECARD Title: 9 Benefits of a Supplier Scorecard Author: AssurX Subject: Enterprise quality management system (EQMS), manufacturers can use the supplier scorecard to mitigate risk, benchmark vendors, and manage supplier performance. WEAK CAPA PROGRAMS HIT GLOBALLY BY FDA WARNINGS The good news is that taking a look at FDA inspection patterns can help medical device manufacturers proactively assess and improve their own programs. In a June 30 warning letter, the agency zeroed in on the CAPA program at TriMed, Incorporated, a manufacturer of implantable bone fixation systems in Santa Clarita, California. COMPLETE AUTOMATED DOCUMENT MANAGEMENT SOFTWARE Document Management Software. AssurX’s document management software automates the storage and management of documents across the enterprise and throughout the document lifespan. The software provides collaboration tools to let you create, modify, review, and distribute documents in a controlled manner—all from a secure central

repository

TRAINING MANAGEMENT SOFTWARE AssurX Training Management software ensures your personnel is always effectively prepared for the job. All training history is properly documented, accessible, and auditable to meet quality management and regulatory compliance requirements. Take charge of all training requirements, activities, materials/courses, and histories throughout

your

SUPPLIER QUALITY MANAGEMENT SOFTWARE Extend quality across global supplier networks. AssurX Supplier Quality Management (SQM) helps your organization manage suppliers, vendors, contract manufacturers, and service providers with one solution designed to enforce your quality and compliance goals. Quickly detect, inspect, contain and drive action (s) to resolve

quality issues to

MANAGEMENT TEAM

TAMAR JUNE, PRESIDENT & CEO, is an entrepreneur who has mastered the balance of technology, team leadership, and customer-focused business throughout her career. Joining the two co-founders of AssurX in 2000, she helped grow the organization from a lean startup to hundreds of thousands of worldwide users in companies across various markets. ENERGY AND UTILITIES INDUSTRY SOLUTIONS AssurX provides an end-to-end, automated NERC compliance software solution that expands seamlessly to address all Energy & Utilities industry regulations. One enterprise-wide, flexible system consistently manages operations, identifies risks, and demonstrates compliance across all critical operations. Learn about the AssurX

system for Energy

VALIDATION SERVICES FOR ENTERPRISE QUALITY MANAGEMENT The AssurX Validation Management Services team will work with you to create a validation plan that establishes a disciplined and structured approach to your validation projects. Also, Validation Services can assist with the overall risk-based strategy for achieving and maintaining a validated process. The team can help you identify and

analyze

THE SIX C’S OF A MODERN COMPLAINT MANAGEMENT SYSTEM 2020 The modern approach to investigating and resolving complaints can be condensed into six core categories. Each category represents a critical component that connects the complaint process interdependencies. 1 – Collection. According to FDA 21 CFR 820 and akin to the ISO 13485 definition, a complaint is “any written,

electronic or oral

THE FDA'S FAST TRACK MODEL FOR SAMD PRECERTIFICATION Want to be part of FDA’s SaMD precertification program?Get your quality management system up to par. Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies. OPINION: 3 REASONS TO CONSIDER SAAS FOR QUALITY MANAGEMENT The SaaS provider’s paycheck directly depends on providing all services reliably, regardless of whether the service is customer-facing or not. There’s more of a vested interest in rapid deployment, fixing problems faster, providing higher SLAs, and going the extra mile to make happy customers. FDA WARNING LETTERS EMPHASIZE DOCUMENT CONTROL SYSTEM First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. Both highlight the vital importance of documenting evidence and risk management activities to maintain compliance with FDA guidelines. QUALITY MANAGEMENT SYSTEM & REGULATORY COMPLIANCE The AssurX software platform is a highly versatile automated Quality Management System (QMS) and Regulatory Compliance Management Software used to improve quality and compliance, streamline workflow, control risk, and better manage any enterprise. Our QMS and Regulatory Compliance Management software puts quality at your enterprise’s COMPLIANCE MANAGEMENT SOFTWARE AssurX compliance management software automates the tracking and control of compliance-related activities—from documentation to planning, scheduling, reporting, mitigation, and audit for the enterprise. Assurx offers a versatile, closed-loop system that helps you consistently measure, demonstrate, and sustain compliance for an

array of

FOOD AND BEVERAGE INDUSTRY QUALITY & COMPLIANCE MANAGEMENT Achieve the highest Food and Beverage quality and compliance while maintaining production efficiency and profitability. AssurX provides fast, detailed visibility and traceability of product quality and safety from the supply chain to the consumer and a means to easily comply with Food and Beverage industry regulatory standards from the FDA, USDA, HACCP, and others.

MANAGEMENT TEAM

TAMAR JUNE, PRESIDENT & CEO, is an entrepreneur who has mastered the balance of technology, team leadership, and customer-focused business throughout her career. Joining the two co-founders of AssurX in 2000, she helped grow the organization from a lean startup to hundreds of thousands of worldwide users in companies across various markets. 5 QUALITY MANAGEMENT TRENDS TO WATCH IN 2021 HOW TO MEET NEW EU MDR REQUIREMENTS FOR VIGILANCE AND The new EU MDR significantly strengthens requirements around post-market vigilance and reporting, two areas where MDD requirements were relatively light. The new regulation incorporates the principles of ISO 13485 for medical devices and ISO 14971 for medical device risk management, applying them to the entire manufacturing process. While

EU

5 PILLARS OF MODERN ENTERPRISE QUALITY MANAGEMENT SYSTEMS These five attributes are not only powerful building blocks of effective enterprise quality management systems, but they are also industry agnostic. Pillar 1: Process Integration. While most companies execute on these functions, the degree of integration and automation varies greatly from company to company. SUCCESSFUL QMS IMPLEMENTATION REQUIRES CLEARLY DEFINEDSEE MORE ON

ASSURX.COM

9 BENEFITS OF A SUPPLIER SCORECARD Title: 9 Benefits of a Supplier Scorecard Author: AssurX Subject: Enterprise quality management system (EQMS), manufacturers can use the supplier scorecard to mitigate risk, benchmark vendors, and manage supplier performance. WEAK CAPA PROGRAMS HIT GLOBALLY BY FDA WARNINGS The good news is that taking a look at FDA inspection patterns can help medical device manufacturers proactively assess and improve their own programs. In a June 30 warning letter, the agency zeroed in on the CAPA program at TriMed, Incorporated, a manufacturer of implantable bone fixation systems in Santa Clarita, California. QUALITY MANAGEMENT SYSTEM & REGULATORY COMPLIANCE The AssurX software platform is a highly versatile automated Quality Management System (QMS) and Regulatory Compliance Management Software used to improve quality and compliance, streamline workflow, control risk, and better manage any enterprise. Our QMS and Regulatory Compliance Management software puts quality at your enterprise’s COMPLIANCE MANAGEMENT SOFTWARE AssurX compliance management software automates the tracking and control of compliance-related activities—from documentation to planning, scheduling, reporting, mitigation, and audit for the enterprise. Assurx offers a versatile, closed-loop system that helps you consistently measure, demonstrate, and sustain compliance for an

array of

FOOD AND BEVERAGE INDUSTRY QUALITY & COMPLIANCE MANAGEMENT Achieve the highest Food and Beverage quality and compliance while maintaining production efficiency and profitability. AssurX provides fast, detailed visibility and traceability of product quality and safety from the supply chain to the consumer and a means to easily comply with Food and Beverage industry regulatory standards from the FDA, USDA, HACCP, and others.

MANAGEMENT TEAM

TAMAR JUNE, PRESIDENT & CEO, is an entrepreneur who has mastered the balance of technology, team leadership, and customer-focused business throughout her career. Joining the two co-founders of AssurX in 2000, she helped grow the organization from a lean startup to hundreds of thousands of worldwide users in companies across various markets. 5 QUALITY MANAGEMENT TRENDS TO WATCH IN 2021 HOW TO MEET NEW EU MDR REQUIREMENTS FOR VIGILANCE AND The new EU MDR significantly strengthens requirements around post-market vigilance and reporting, two areas where MDD requirements were relatively light. The new regulation incorporates the principles of ISO 13485 for medical devices and ISO 14971 for medical device risk management, applying them to the entire manufacturing process. While

EU

5 PILLARS OF MODERN ENTERPRISE QUALITY MANAGEMENT SYSTEMS These five attributes are not only powerful building blocks of effective enterprise quality management systems, but they are also industry agnostic. Pillar 1: Process Integration. While most companies execute on these functions, the degree of integration and automation varies greatly from company to company. SUCCESSFUL QMS IMPLEMENTATION REQUIRES CLEARLY DEFINEDSEE MORE ON

ASSURX.COM

9 BENEFITS OF A SUPPLIER SCORECARD Title: 9 Benefits of a Supplier Scorecard Author: AssurX Subject: Enterprise quality management system (EQMS), manufacturers can use the supplier scorecard to mitigate risk, benchmark vendors, and manage supplier performance. WEAK CAPA PROGRAMS HIT GLOBALLY BY FDA WARNINGS The good news is that taking a look at FDA inspection patterns can help medical device manufacturers proactively assess and improve their own programs. In a June 30 warning letter, the agency zeroed in on the CAPA program at TriMed, Incorporated, a manufacturer of implantable bone fixation systems in Santa Clarita, California. COMPLETE AUTOMATED DOCUMENT MANAGEMENT SOFTWARE Document Management Software. AssurX’s document management software automates the storage and management of documents across the enterprise and throughout the document lifespan. The software provides collaboration tools to let you create, modify, review, and distribute documents in a controlled manner—all from a secure central

repository

TRAINING MANAGEMENT SOFTWARE AssurX Training Management software ensures your personnel is always effectively prepared for the job. All training history is properly documented, accessible, and auditable to meet quality management and regulatory compliance requirements. Take charge of all training requirements, activities, materials/courses, and histories throughout

your

SUPPLIER QUALITY MANAGEMENT SOFTWARE Extend quality across global supplier networks. AssurX Supplier Quality Management (SQM) helps your organization manage suppliers, vendors, contract manufacturers, and service providers with one solution designed to enforce your quality and compliance goals. Quickly detect, inspect, contain and drive action (s) to resolve

quality issues to

MANAGEMENT TEAM

TAMAR JUNE, PRESIDENT & CEO, is an entrepreneur who has mastered the balance of technology, team leadership, and customer-focused business throughout her career. Joining the two co-founders of AssurX in 2000, she helped grow the organization from a lean startup to hundreds of thousands of worldwide users in companies across various markets. ENERGY AND UTILITIES INDUSTRY SOLUTIONS AssurX provides an end-to-end, automated NERC compliance software solution that expands seamlessly to address all Energy & Utilities industry regulations. One enterprise-wide, flexible system consistently manages operations, identifies risks, and demonstrates compliance across all critical operations. Learn about the AssurX

system for Energy

VALIDATION SERVICES FOR ENTERPRISE QUALITY MANAGEMENT The AssurX Validation Management Services team will work with you to create a validation plan that establishes a disciplined and structured approach to your validation projects. Also, Validation Services can assist with the overall risk-based strategy for achieving and maintaining a validated process. The team can help you identify and

analyze

MEDICAL DEVICE MANUFACTURING QUALITY AND COMPLIANCE Managing industry best practices to drive product innovation and patient safety. AssurX medical device manufacturing quality management software (QMS) is designed to balance the complexity of global quality management and regulatory requirements while maintaining a high level of flexibility to adapt to continual industry and operational changes. ENERGY & UTILITIES RESOURCES Energy & Utilities Resources. We’ve assembled Energy & Utilities reports on industry topics related to NERC compliance and regulatory compliance software. THE SIX C’S OF A MODERN COMPLAINT MANAGEMENT SYSTEM 2020 The modern approach to investigating and resolving complaints can be condensed into six core categories. Each category represents a critical component that connects the complaint process interdependencies. 1 – Collection. According to FDA 21 CFR 820 and akin to the ISO 13485 definition, a complaint is “any written,

electronic or oral

THE FDA'S FAST TRACK MODEL FOR SAMD PRECERTIFICATION Want to be part of FDA’s SaMD precertification program?Get your quality management system up to par. Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies. 1-888-927-7879 | 1-408-778-1376

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