The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse events and medication error reports submitted to FDA. Compliant with the reporting guidance ICH E2B2 issued by the International Conference on Harmonisation, FDA uses FAERS data to monitor, identify and analyze adverse events and medication errors. The FAERS database, which follows FDA Adverse event…

ComplinaceQuest’s ISO 14001 Management System helps organizations to improve resource efficiency, reduce waste, and drive down costs and remain complaint with ISO 14001 standard. The introduction of ISO 14001:2015 includes several new updates all aimed at making environmental management more comprehensive and relevant to the supply chain while focusing on the improvement of environmental…

ComplianceQuest is a 100% cloud based Quality, Health, Safety and Environmental (QHSE) Solution Suite to help you drive quality excellence which leads to business growth while at the same time you can embrace a culture of health and safety to reduce costs of accidents or non-conformance. It is built natively on the Salesforce.com platform, one of the leading business cloud platforms, ensuring high security, future readiness and scalability to the system. Aligning your organization with our…

The medical device industry manufacturers a range of technologies and applications, ranging from simple hand-held tools to more complex computer-controlled large surgical machines. While the guidance does not include a set of rigorous implementation methods, it consists of quality system requirements coupled with explanations and relevant design control principles examples. Design control is considered relevant for…

The medical device industry manufacturers a range of technologies and applications, ranging from simple hand-held tools to more complex computer-controlled large surgical machines. While the guidance does not include a set of rigorous implementation methods, it consists of quality system requirements coupled with explanations and relevant design control principles examples. Design control is considered relevant for…

FDA design control is defined as an interrelated set of quality practices and processes for medical devices design and manufacturing. Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design controls make a systematic assessment of the design an integral part of development. With design control, any deficiencies in…

A document control software enables the management of documents right from creation, revision, distribution and accessibility based on reliability and trust. Only with the right document control strategy can the quality processes within your organization be truly collaborative. It is at the core of compliance with FDA and ISO requirements, in addition to adherence to other compliance and regulatory…

Job safety analysis (JSA) is a procedure that helps integrate accepted safety and health practices into a particular task or job operation. In JSA, the ultimate goal is to identify potential hazards in every step of a process and recommend the safest way to execute the job. JSA is a written procedure developed to understand, review, minimize or eliminate hazards associated with work processes. A job safety…

Health and Safety Incident Management software to help centralize all your incident data, near misses, safety observations, fulfill CAPA and OSHA regulations.

Centralize all your incident data, near misses, safety observations, investigations for implementing agile corrective actions with ComplianceQuest’s Health and Safety Incident Management Solution.

Furthermore, mitigate risks and prevent…

Health and Safety Incident Management software to help centralize all your incident data, near misses, safety observations, fulfill CAPA and OSHA regulations.

Centralize all your incident data, near misses, safety observations, investigations for implementing agile corrective actions with ComplianceQuest’s Health and Safety Incident Management Solution.

Furthermore, mitigate risks and prevent…

Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design control make a systematic assessment of the design an integral part of development. With design control, any deficiencies in design input requirements or discrepancies between the proposed designs and requirements are detected early and corrected immediately in…