ComplianceQuest
Website: ComplianceQuest is an Enterprise Quality, Safety and Environment Management (QHSE) solutions platform natively built and run on Salesforce technologies. We help our customers of all sizes deliver quality products and services in the safest, most sustainable way by mitigating risk, problems, and inefficiencies while protecting customers, employees, suppliers, and brands.
A step-by-step guide for implementing QMS ISO 9001 for Compliance Culture. What is ISO 14001 Certification? Its Importance and Implementation Guide. What are the benefits of ISO 14001 Certification?
Implementation of ISO 14001 improves the environment and helps in understanding the difference between an easy and successful implementation and a difficult and ruinous one. Here are a few benefits of ISO 14001 Certification:Enhance an organization’s image and credibility In today’s tech-savvy world, consumers are more concerned about the environmental practices of the companies that produce the products they use.
What is IATF 16949 Certification and IATF 16949 Audit Checklist? A Comprehensive Guide to FDA’s 21 CFR Part 11 Compliance Checklist. The objective of the regulation is to streamline compliance and allow businesses to speed up their operations with electronic records management systems and signatures.
These compliance guidelines are especially important when implementing a software solution that is designed to facilitate 21 CFR Part 11 compliance. Here are some of the benefits of 21 CFR Part 11 compliance including: Better operational efficiencyLow expensesEnhanced system securityIn-built efficient employee trainingHuge savings on storage spaceSimplified patent filing The objective of the regulation is to streamline compliance and allow businesses to speed up their operations with electronic records management systems and signatures.
These compliance guidelines are especially important when implementing a software solution that is designed to facilitate 21 CFR Part 11 compliance. Here are some of the benefits of 21 CFR Part 11 compliance including: What is CAPA - Corrective and Preventive Action? CAPA Management. Corrective and Preventive Action (CAPA) process helps an organization to analyze and collect relevant product-related information, investigate and identify product and quality problems, and trigger appropriate and effective corrective or preventive actions to eliminate a problem and prevent its recurrence.
CAPA has two different components, corrective action and preventive action. Corrective action is used to address systemic non-conformities when they occur while preventive actions address the risk of non-conformities that are likely to happen. An efficient and compliant CAPA system needs a set of data in order to identify the problems, implement solutions, and document the outcome and further changes.
What is GMP Training? GMP Training Importance, Need and Requirements. What is cGMP compliance? Why is cGMP compliance so important? What is Compliance Training? Business Impact With Compliance Training. Compliance training is a significant component for businesses to help companies mitigate and avoid the risk of lawsuits and heavy penalties.
Other enormous benefits of compliance training include:Better productivity in the workplace: Compliance training enables employees to understand how to operate within the law as well as standards that have been introduced by the company to avoid any penalties or lawsuits. Ultimately, when employees are more productive, the company can generate higher profits.Improved workplace culture: Compliance training can help employees understand the rules and regulations so that they can perform their tasks more appropriately and more efficiently. What is GxP Compliance? Comprehensive guide to GxP & FDA Compliance.
GxP refers to the ‘good practice’ guidelines and regulations and GxP compliance is an essential component within the life science industries created to ensure that food, medical devices, drugs and other life science products are safe and effective.
GxP compliance is ensured by agencies and government bodies through regular inspections, certification requirements, and unplanned auditing. As a result, many companies are now trying to adopt GxP compliance software to protect their markets, supplier status and future business as they will get numerous advantages including:Creating good performing products with consistent qualityReducing risk of product failureProviding evidence that regulated products comply with regulatory requirementsEnsuring knowledge is maintained in your organizationObtaining accountability for regulated activity across an organization. A Blueprint for an Effective and Efficient Remote Audit Process. The pandemic has accelerated the adoption of remote audits, even in highly regulated industries like manufacturing and medical devices.
With the COVID-19 virus lurking around and a wide variety of disruptions affecting enterprises – the role of audits has become more crucial than ever. Enterprises are reinventing their QMS workflow to ensure all quality and regulatory compliance requirements are met. A robust audit management process helps quality leaders “know all their gaps”. Internal audits and audit planning play a key role in building a continuously improving (CI) quality management workflow. In spite of travel and other restrictions, organizations are ensuring quality and compliance requirements are met with a robust, well-defined remote audit process. ISO 9001ISO 13485ISO 14001ISO 50001ISO 45001/OHSAS 18001EN/AS 9100 seriesISO 22000ISO/IEC 27001MDSAP Quality leaders also believe that remote audits are here to stay.
Ensure Adherence to your Supplier Quality Agreements. With manufacturing and supply chain processes becoming more complex, critical aspects of a product are being outsourced to external global suppliers or product parts have become commodity purchases.
It has become imperative that the quality of these products also meet regulatory requirements. Of course, regulatory compliance and quality metrics, ideally, must not delay time to market. A well-designed Supplier Quality Agreement plays a crucial role in ensuring this compliance. In our recent whitepaper, we take an in-depth look at SQAs. This blog is a short excerpt from this whitepaper. Apart from being a regulatory requirement, SQAs are legally binding documents that can serve as critical evidence during a lawsuit or litigation. A Year in Review: 5 Highlights from 2020 at ComplianceQuest. Would you like to guess what was declared ‘word of the year’ in 2020?
It’s an easy one! Okay, here you go. Merriam-Webster Dictionary announced ‘pandemic’ as the word of 2020. No surprises there! It has been one of the most challenging years for people, enterprises, and governments all over the world. In this post – as we look back at 2020 – here are five key highlights we would like to share with you. Importance of PPE for employee well being and workplace safety.
Personal Protective Equipment (PPE) is not a new term in many industries with high risk of hazards.
In fact, OSHA has codified the standards for PPE in Title 29 of the Code of Federal Regulations (CFR), Part 1910 Subpart I, as part of the General Industry Standards and 29 CFR 1926.95-106 for the construction industry. Post-pandemic, restart of businesses has added yet another reason for employers to provide PPE to their employees to prevent the spread of the COVID-19 infection. Restart of on-site operations has boosted up demand for PPE As per the OSHA guidance, PPE is only the last line of defense in case of most engineering and hazard-based needs. Businesses need to assess the hazard to determine if a PPE is required at all and provide only appropriate PPE materials for the job. However, the COVID-19 pandemic created a new need due to its virulent nature. Protecting the workforce by establishing and standardizing operating procedures, processes, and tools. Risk-Based Approach by FDA for Software Validation.
At ComplianceQuest, we recently organized a webinar on – How Will FDA’s New Approach to CSV Make Implementations Easier?
In this webinar, Tim Fischer of Great Solutions Inc., gave us a detailed perspective of why the FDA is moving to a risk-based approach for software validation. In this post, we share key takeaways from the virtual event. The Journey of how a construction industry pioneer transformed its safety management process in just 12-Weeks. At ComplianceQuest, we recently organized a webinar featuring one of our clients, the VP of operations and safety at a leading construction services company in the dewatering space. The company has been in business for over 80 years, solving complex problems related to groundwater management in the construction industry. In the webinar, the safety leader jumped straight to the point and spoke about why in this day and age a manual system to manage safety processes won’t work. He believes organizations which use a manual system to track safety processes suffer from: Decentralized, non-automated processes which work only in silosLack of collaboration, accountability and transparency of safety dataInsufficient data for decision makingInability to drive continuous improvement of workflows or processes In this blog, we highlight how this company digitally transformed its safety management process in just 12 weeks and – in the process – took its total recorded incident rate (TRIR) to 0 in 2020.
How Medical Device Manufacturers Can Reduce Their Return Merchandise Authorization (RMA) Costs with a Next-Gen EQMS. The manufacturing of a medical device requires process control at every step due to its criticality for human health and life. It is, therefore, more stringently regulated than most other industries. However, despite the many checks and balances, returns due to defects are not unheard of, and dealing with it satisfactorily is crucial to retain brand reputation and customer loyalty. Better still is to reduce the need for RMA to improve profit margins due to its impact on resources for assessing and repairing the product and sometimes even reworking the process to avoid the defect.
The Process of Returning Merchandise The manufacturer of the medical device has to make sure that the product is repaired or replaced, provided certain conditions are met. Best tips for Employee Well-being for ideal working environment. Plant workers are stressed and fearful of going back to work these days. However, they need to work and are looking at employers to help them FEEL safer going back to work each day. These are the workers that are on the line making products and fulfilling shipments. Not the workers sitting at home doing zoom meetings. This has led to a growing emphasis on overall employee well-being.
Shop floor automation with cloud-based EQMS and EHS. At ComplianceQuest, we have put together a checklist whitepaper – 4-step guide to digitalizing shop floor operations – based on our experience of implementing our QHSE (EQMS + EHS) product at 1000+ customer locations across the world. We’ve served shop floor leaders across a range of sectors including automotive, medical device, oil and gas, electronics and hi-tech, consumer goods and more. This blog is a short excerpt from this whitepaper Next, our focus is to enhance our internal shop floor operations. Effective Incident Visibility Next-Gen EHS by ComplianceQuest. The global Environment, Health, and Safety (EHS) market is expected to grow at a Compound Annual Growth Rate (CAGR) of 10.2% from USD 5.3 billion in 2019 to USD 8.6 billion by 2024, according to a market research report.
The drivers for this growth include the need for real-time visibility and stability in business operations to achieve higher levels of efficiency, accuracy, and security in organizations. Additionally, among the various industries, the energy and utilities sector is expected to contribute the maximum to this growth — due to the need to keep pace with changing regulations, high-cost of failure of safety or environment parameters, and a crying need for well-planned risk mitigation in this segment. Why automate your enterprise’s EHS process?
Today businesses are spread out geographically, having operations as well as customers in different parts of the world. OSHA revises its maximum penalty for 2021. Starting January 15, 2021, Occupational Safety and Health Administration (OSHA) increased the maximum civil monetary penalties for violations by approximately 2%. The role of emerging technologies in health and safety management. Emerging from the pandemic’s grappling hands, workplace safety and employee well-being have become essential in removing employees’ anxiety when coming back to work. As employers commence return-to-work programs, the need for health and safety should be about creating employee awareness by imparting a collaborative culture of safety in the company. Control Workplace Safety Digitaly for Employee well-being. Till the end of 2019, digital transformation was an inevitable part of growth but happening at a much slower pace than now.
An EHS Solution designed to drive an enterprise-wide Safety Culture. A report from McKinsey Global Institute, simply titled “Good health is good business. Here’s why,” explains the importance of employee health for lasting economic benefits and points out that chronic health issues such as back pain and headache cause a 5% decrease in productivity. Why Quality Leaders in Life Sciences Need a Next-Gen Quality Management System. For quality leaders in life sciences industries, the top three challenges are:
The Cost of Non-compliance. As the regulatory environment gets more and more stringent for regulated industries such as medical devices, pharmaceutical, and life sciences, we hear of even leading brands being penalized on various counts – deceptive marketing, violation of books, records and internal accounting controls, off-label or unapproved promotion of medical products, Controlled Substances Act violation, consumer protection violation and so on. In the pharmaceutical industry alone, total penalties from compliance-related violations have crossed over US $50 billion since 2000.
The numbers are not too far behind in other regulated industries as well. What is OSHA Regulations? OSHA Regulations and Standards. Complete OSHA Inspection checklist and Compliance Checklist. Occupational Health and Safety Act and Guidelines. The United States – OSHA Compliance and Requirements. OSHA Safety - occupational health and safety administration management system. With Health & safety gaining heightened significance in the current circumstances and with the health & safety heads having to manage remotely, the ComplianceQuest EHS solution enables seamless management of your organization’s complete health and safety management program through a range of intuitively integrated tools and applications.
ComplianceQuest’s Safety, Health, and Environment management system is built from the ground up on the Salesforce platform. This ensures that the EHS is flexible, scalable, and integrates seamlessly with other ERP, CRM, and EQMS platforms. Specifically, it helps build robust processes for the following: Design: Build exhaustive processes, workflows, and checklists to manage workplace safety interventions.Monitor: Track workplace safety data in real-time, with data visibility across the organization.Act: Take action based on predictive analytics and a proactive mindset.Improve: Take corrective or preventive action as needed in a timely manner. OSHA workplace safety and OSHA safety standards Complete Overview. A Comprehensive Guide to ISO Training, Importance and its Benefits.
What is ISO 45001 Certification ? ISO 45001 occupational health and safety (OH&S) management. Environmental Management - ISO 14001 Audit and Checklist. What is ISO 13485 QMS software and Audit Checklist? What is ISO Certification? What is importance of ISO Certification? ISO 9001 Implementation Process- ComplianceQuest. Complete guide on Quality inspection from definition to its implementation. Quality Assurance vs Quality Control. What is ISO 14001 Certification? Its Importance and Implementation Guide. What is CAPA - Corrective Action, Preventive Action? CAPA Management. What is Compliance Training? Business Impact With Compliance Training. ComplianceQuest Solutions. Document Management Solution for compliance-based documents control.
A Comprehensive Guide to FDA’s 21 CFR Part 11 Compliance Checklist. What is IATF 16949 Certification and IATF 16949 Audit Checklist? European Medical Device Regulation. What is GMP Training? GMP Training Importance, need and requirements. A step-by-step guide for implementing QMS ISO 9001 for Compliance Culture. What is FDA ISO 13485? A complete guide to ISO 13485 and FDA QSR. A Comprehensive Guide to ISO Training, Importance and its Benefits. What is ISO 45001? ISO 45001 Certification, occupational health and safety (OH&S) management.
What is ISO Certification? What is importance of ISO Certification? Environmental Management - ISO 14001 Audit and Checklist. What is ISO 13485 QMS software and Audit Checklist? ComplianceQuest Solutions. Document Management Solution for compliance-based documents control. Health and Safety Incident Management System- ComplianceQuest. What is Sustainability Management? Definition, Importance and Features. What is Quality Management System QMS Software. ISO 9001 Implementation Process- ComplianceQuest. What is Supplier Management. ComplianceQuest Solutions. Complete OSHA Inspection checklist and Compliance Checklist. Occupational Safety and Health Act – OSHA. OSHA Compliance and Requirements. OSHA Safety - occupational health and safety administration management system. A Complete Guide to OSHA workplace safety standards and regulations.
What is Document Control and Documemt Control Software? Document Management Software (DMS) for complete document lifecycle. What is HSE - Health, Safety, Environment Management System. Benefits, regulations and importance. Health and Safety Management Systems. What is Employee Safety and its importance & responsibilities? What is Workplace Safety? Its needs, benefits and importance. What is Safety Management System (SMS)? Health and Safety Incident Management System- ComplianceQuest. ComplianceQuest Solutions. What is QHSE? What is QHSE Management System?
EHS - Environment Health and Safety Management. ComplianceQuest Solutions. Environmental Management Software System. Understanding the relation between quality and safety. What Is Quality Audit? Importance of Quality Auditing. Quality Management Training, Cloud-based Employee Training Software. What is Quality Inspection? Objectives, Benefits, Types & Importance of QI.
What is Quality Assurance? How it is different than Quality Control? Environment Health Safety and Quality - EHSQ. ComplianceQuest Solutions. Environmental Management Software System. EHS - Environment Health and Safety Management. EHS - Environment Health and Safety Management. Supplier Management Software. Training Management Software System - ComplianceQuest. ComplianceQuest Solutions. Medical Devices Quality Management - ComplianceQuest. ISO 14001 environmental management system - ComplianceQuest. ISO 9001 Quality Management System & QMS Software Requirements. What is ISO 45001 for occupational health and safety (OH&S) ComplianceQuest Solutions.