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 the development process.
A compliance audit is a formal review of an organization’s procedures and operations mainly focusing on whether an entity is complying with internal rules, regulations, policies, decisions, and procedures.
Compliance training is employee training authorized by regulation, legislation or policy that helps to reduce risk, maintain your reputation and improve the workplace environment to improve worker productivity in the long run.
FDA compliance has been designed to ensure that companies enforce QMS processes that will create higher quality products.In today’s competitive world, it is difficult for businesses to meet stringent FDA regulations as they are seeking to balance both quality control and ROI.
CAPA FDA helps to collect and analyze information, identify and investigate product and quality problems, and take appropriate corrective and/or preventive action to prevent their recurrence.
FDA training is necessary to remain compliant.It makes employees keep abreast of the current regulations and guidance and how to adhere to them.The FDA training program includes various subjects — from conducting inspections to responding to 483s or warning letters.
ISO training allows organizations to streamline and optimize their in-house training processes.
Quality managers use ISO 13485:2016 audit checklist to determine if the QMS aligns with the ISO 13485 software standard requirements.The ISO 13485 audit checklist is used for internal audit while preparing the system for a third-party ISO 13485 certification audit.The ISO 13485 audit checklist allows quality managers to document evidence of compliance based on processes, standard requirements, and process characteristics
An ISO 14001 checklist is used during EMS audit to check for compliance with ISO 14001:2015.This ISO 14001 checklist ensures that the current EMS meets all the required ISO standards.
Behavioral observation is the systematic recording of behavior by an external observer.The systematic nature of behavioral observation is characterized by detailed procedures designed to collect reliable and valid data on client behavior and the factors that control it.
ISO 14001 certification is a reliable, effective, and responsible environmental management system for business operations.The amount of human labor, time, and resources to create and implement a total EMS solution is excessively onerous for many businesses.
ComplianceQuest’s Health & Safety Management System Framework combines safety management methodology with robust technology to collect, collate and trend health and safety data related to any risk to the health and wellbeing of clients, staff, contractors or the community.
HSEQ stands for Health, Safety, Environment and Quality.An HSEQ Management System is a tool aimed at quality, occupational health and safety, and the environment to prevent or mitigate both human and economic losses arising from accidents, adverse occupational exposures, and environmental events
Safety investigation is conducted to prevent accidents in a work environment.Safety managers must conduct an effective safety investigation periodically to ensure the safety standards are met to avoid penalties and prevent accidents.
Hazard analysis is a continuous process that has to be performed to mitigate hazards that can be introduced at any stage from requirements, design, development, product testing, installation, commissioning, operation, system maintenance, and disposal of a system.
JSA is a written procedure developed to understand, review, minimize or eliminate hazards associated with work processes.
CQ’s Health and Safety Management Solution enables companies to centralize all incident data, near misses, safety observations, perform an investigation, and implement corrective actions.
Work health and safety (H) refers to the risks of injury and illnesses in the workplace impacting employees, visitors, customers, and suppliers.Businesses need to do a risk assessment to identify the hazards and risks in their workplace and put in place control measures to prevent their occurrence or reoccurrence, as the case may be.
ComplianceQuest offers a Workplace Safety App for Work.com to help employers manage their employee health and safety information effectively and efficiently.
An unfortunate accident often acts as the catalyst to move from silos to a more integrated system for quality and safety management.