2024-05-23 06:02
The three key ingredients for the success of a medical device are: Innovation or differentiation that sets a product apart from its competitors Safety and performance that reassure the patie… Read More
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A Blueprint For An Effective And Efficient Remote Audit Process - Compliancequest Qhse Solutions Blog
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Tags:
supplier management
key performance
emerging
management
medical devices essential
chip manufacturing sector
riskbenefit
innovation patient safety
manufacturing sector
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he 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.
2024-05-22 12:48
Each industry has its own quality requirements based on unique characteristics, risks, raw materials used, and the availability of skilled workers. However, some quality requirements are com… Read More
2024-05-22 11:46
Quantifiable measures used to evaluate the success of an organization, employee, etc., in meeting objectives for performance
The post Key Performance Indicators (KPIs) appeared first on Comp… Read More
2024-05-22 06:53
The medical device sector is highly regulated worldwide due to the direct impact these products have on patient health and safety, as well as on the healthcare staff handling them. Implantab… Read More
2024-05-21 12:54
Making workplaces safe goes beyond compliance and regulatory requirements. In fact, focusing on employee well-being and the health and safety of all workers must be a core part of a company… Read More
2024-05-21 11:35
Organizational activity aimed at enhancing the skills, knowledge, and competencies of an individual or group
The post Training and Development appeared first on ComplianceQuest: AI-powered P… Read More
2024-05-21 11:26
Process for evaluating and monitoring device component suppliers
The post Supplier Management appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-21 11:19
Evaluating the potential risks and benefits of a medical device
The post Risk-Benefit Analysis appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-21 11:12
Organization's commitment to quality and compliance
The post Quality Policy appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-21 11:02
Confirmation that design outputs meet inputs and that the device meets user needs
The post Design Verification/Validation appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SR… Read More
2024-05-21 10:45
Formal assessment of design and development activities
The post Design Review appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-21 10:23
Documentation of manufacturing processes for each device unit
The post Device History Record (DHR) appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-21 10:13
Categorization of medical devices based on risk
The post Device Classification appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-21 10:01
People, systems, and processes truly connected across design, development, quality, safety, and customer lifecycles
The post Connected Workers appeared first on ComplianceQuest: AI-powered P… Read More
2024-05-21 04:26
In our first blog as part of the AI ‘Under the Hood’ Series, we wrote a blog titled “Not Just Faster, But Smarter — Enhancing Accuracy and Streamlining Quality, Compl… Read More
2024-05-20 13:54
Operational excellence refers to the “continuous improvement of manufacturing processes to maximize efficiency, performance, and growth while cutting down on expenses and increasing co… Read More
2024-05-20 04:52
Delving deep into the core of discrepancy investigations and root cause analyses is fundamental for cultivating a landscape where CAPAs thrive, ultimately fostering an environment of co… Read More
2024-05-17 11:43
Ability to trace a device's history, use, and location
The post Traceability appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-17 11:35
Confirming that a product meets its specifications
The post Verification appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-17 11:21
Evaluating device ease of use with representative users
The post Usability Testing appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-17 11:04
Process to eliminate microbial contamination on medical devices
The post Sterilization appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-17 10:46
FDA process for evaluating medical device safety and effectiveness before marketing
The post Pre-Market Approval (PMA) appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM P… Read More
2024-05-17 10:28
Process of managing ideas and inventions for new product development and improvement
The post Innovation Management appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Plat… Read More
2024-05-17 10:04
Procedures for managing documents related to medical devices
The post Document Control appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-17 09:36
A laboratory is a critical part of industries such as medical technologies, pharmaceuticals, etc., and is regulated by various standards and regulations to ensure the quality of its operatio… Read More
2024-05-15 13:16
The document where these interrelationships are established is called the Requirement Traceability Matrix (RTM). It provides all the information needed by all the stakeholders to discharge t… Read More
2024-05-14 10:34
Incident reporting and investigation management software are vital tools used by organizations to streamline the process of documenting, tracking, and resolving incidents. These incidents co… Read More
2024-05-14 07:23
The European Union’s Medical Device Regulations (EU MDR), governing the production and distribution of medical devices in the European Union, has been in effect since 26 May 2021, thre… Read More
2024-05-13 10:47
As summer temperatures soar, the risk of heat stress in the workplace becomes a critical safety concern. Heat stress, if not properly managed, can lead to serious health problems such as hea… Read More
2024-05-10 05:13
Join us to learn about an intricately nuanced subject, “The AI Advantage in Pharma: Enhancing GxP Systems and CSV Practices.” Discover how integrating AI tech… Read More
2024-05-09 13:27
The discipline of initiating, planning, executing, controlling, and closing the work of a team to achieve specific goals and meet specific success criteria
The post Project Management appear… Read More
2024-05-09 13:17
Proactive approach to tackling all product-related risks
The post Product Risk appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-09 13:02
Requirements and results of the design and development process
The post Design Input/Output appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-09 12:49
Systematic, independent, and documented process for obtaining evidence and evaluating it objectively
The post Audit appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Plat… Read More
2024-05-08 09:02
Framework for consistent product quality and regulatory compliance
The post Quality Management System (QMS) appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-08 08:47
Organization assessing medical device conformity with regulations
The post Notified Body appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-08 08:38
Collection and analysis of clinical data to demonstrate safety and performance
The post Clinical Evaluation appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-08 07:39
Identifying and mitigating device-related risks
The post Risk Management appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-08 05:20
Join our “OSHA Inspections: Best Practices and Common Pitfalls” webinar to navigate OSHA inspections with ease. Learn from industry experts about preparing for, handlin… Read More
2024-05-06 05:22
Identification and analysis of potential failure modes in products and processes
The post Failure Mode and Effects Analysis (FMEA) appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS… Read More
2024-05-06 05:10
Fundamental safety and performance requirements for medical devices
The post Essential Requirements appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-05-06 05:06
PwC defines Safety Analytics as the science of studying the root causes of workplace accidents. Running analytics on safety data provides a framework for assessing, measuring, monitoring, an… Read More
2024-05-03 12:38
A mid-sized medical device company that made an ECG Patch for remote monitoring was poised to disrupt the market with a groundbreaking new device. The company raised significant capital and… Read More
2024-05-03 05:06
Introduction The healthcare landscape is swiftly advancing due to the progression of medical and communication technologies, heightened awareness among patients and providers, and increasing… Read More
2024-05-03 04:41
Quality management is a fundamental aspect of any manufacturing company, pivotal in ensuring compliance with regulatory standards and internal benchmarks. It not only facilitates the product… Read More
2024-05-03 00:00
Every investment a business makes should have a measurable impact. In the case of an EQMS, the ROI is based on the savings achieved from the prevention of litigations, product recalls, reput… Read More
2024-05-01 04:59
The journey of a product or service begins with identifying a pain point it must address and then deciding on the features and raw materials required to address the issue. During the journey… Read More
2024-05-01 04:41
However, establishing a quality management system is not a one-time activity; it needs continuous improvement. Several reasons can trigger this: Changing regulatory requirements Changing org… Read More
2024-04-30 12:52
Quality management leaders know the metrics that steer their systems towards compliance and efficiency. Yet, understanding what to measure is only the first step. The greater challenge lies… Read More
2024-04-30 07:09
Last year, ComplianceQuest’s Product and Solutions Team caught up with several fast-growing medical device companies at a conference. We met a combination of founders, CEOs, and Qualit… Read More
2024-04-29 12:36
In today’s connected era, where data is king and system inefficiencies are the bane of productivity, seamless integration between business systems has become a critical requirement. CQ… Read More
2024-04-29 10:41
Just recently, the CQ Product and Marketing teams participated in a brainstorming session at a conference for healthcare, medical device, and manufacturing leaders. The topic of discussion (… Read More
2024-04-25 06:17
The post End-to-End Safety Audit Checklists for Pharmaceutical appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-04-25 06:05
Any organization has a variety of tasks to be performed by various departments. These functions intersect at various points and therefore, consistency is essential to minimize confusion. Fur… Read More
2024-04-25 05:02
FDA inspections are more than just routine checks; they are the cornerstone of pharmaceutical success. These critical assessments directly influence public health and a company’s credi… Read More
2024-04-24 13:18
As the landscape of Enterprise Quality Management Systems (EQMS) continues to evolve, driven by technological advancements, regulatory shifts, and changing industry standards, organizations… Read More
2024-04-24 12:57
Proactive Safety Management with Workplace Inspections Safety incidents happen when risks are ignored and allowed to fester and blow up into an incident later. Sometimes, even with diligent… Read More
2024-04-24 12:42
In a constantly evolving environment, businesses must be agile and change with the times, market conditions, customer needs, regulatory requirements, and aspirations. Change can be introduce… Read More
2024-04-24 10:50
The post Reports, Dashboards and Analytics appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-04-24 06:08
The post Safety Intelligent Analytics appeared first on ComplianceQuest: AI-powered PLM, QMS, EHS & SRM Platform Read More
2024-04-23 09:49
The product development cycle refers to the various stages involved in the product life cycle, right from design and development to manufacturing, supplier and customer processes, and eventu… Read More
2024-04-22 12:35
In 2022, OSHA reported 5,486 fatal work injuries, which is about 3.7 deaths per 100,000 full-time workers. According to the Bureau of Labor Statistics, the private sector experienced 2.8 mil… Read More
2024-04-19 12:30
Empowering the Workforce with Digital Transformation in Standard Operating Procedures TAMPA, Fla., April 17, 2024 (Newswire.com) – ComplianceQuest, a leader in AI-driven Product L… Read More
2024-04-17 07:12
Some of the key aspects the regulations ensure include: Documentation: Documenting processes serve two purposes – it demonstrates compliance and ensures process continuity and standard… Read More
2024-04-17 04:48
Join us for an insightful webinar on leveraging integrated data analytics for predictive quality management in manufacturing. Discover how manufacturers can harness the power of th… Read More
2024-04-16 11:46
Workplace safety is critical for every organization today, not just because it is a regulatory requirement, but also because the organization’s reputation, employee engagement, and cus… Read More
2024-04-16 04:50
The development and distribution of drugs is a high-risk business – the development and testing of drugs can take a long and need several iterations; distribution and storage need to b… Read More
2024-04-12 09:12
Introduction to QMS Audit Software QMS audit software streamlines quality management system audits, ensuring adherence to standards like ISO 9001. It automates audit scheduling, task assignm… Read More
2024-04-12 09:05
Several key trends are shaping this evolution: Resilience and Agility: Recent disruptions in global supply chains have underscored the importance of resilience and adaptability. Companies in… Read More
2024-04-12 09:00
Here are six reasons why cultivating such a culture is crucial Enhanced Customer Satisfaction: In a quality-focused culture, organizations prioritize meeting and surpassing customer expectat… Read More
2024-04-11 10:26
Gain valuable insights into the holistic safety landscape within your organization by using analytics and dashboards with related reports. Visualize your data to determine trends, identify p… Read More
2024-04-11 06:48
Introduction ISO 45001 is a proven global standard that defines the criteria for an occupational health and safety (OH&S) management system. It presents a clear framework to boost workpl… Read More
2024-04-11 06:44
Elevate Your Skills and Professional Standards: The Introduction of CQ University for Mastery of the CQ Digital Quality+ Platform. TAMPA, Fla., April 9, 2024 (Newswire.com) – Comp… Read More
2024-04-08 09:49
What Is Poor Quality? Poor quality refers to a lack of excellence or substandard product, service, or experience attributes. It encompasses various aspects such as durability, reliability, f… Read More
2024-04-08 09:12
To enable this, quality leaders need inputs from all hands on the shop floor, as they will have insights to help identify and mitigate risks. This requires a strong communication system wher… Read More
2024-04-08 07:40
The 5 key issues that ISO 45001 helps organizations address include: Identifying Hazards and Assessing Risks : To enable proactive management of health and safety in organizations, ISO 45001… Read More
2024-04-05 13:24
In today’s fast-paced and complex business environment, safety management is no longer just about compliance – it is a critical component of operational excellence and organizati… Read More
2024-04-05 04:26
Introduction Businesses are obligated to adhere to a myriad of laws, rules, guidelines, and specifications established by regulatory bodies and authorities. These regulations serve to safegu… Read More
2024-04-04 05:03
Unlock the secrets to mastering CAPA writing. Our expert instructor will guide you through recognizing common writing pitfalls and adopting best practices for clear and compliant documentati… Read More
2024-04-02 13:13
The product lifecycle management system improves the efficiency and effectiveness of the entire product development process, from ideation to post-market servicing, customer feedback handlin… Read More
2024-04-02 06:24
Siemens AG Siemens AG, headquartered in Germany, is a multinational conglomerate known for its technology, industry, infrastructure, and healthcare expertise. Over the years, Siemens has dem… Read More
2024-04-02 06:14
Benefits of Version Control Tracks Changes and History: Version control systems like Git or Subversion record every change made to your documentation. This creates a complete history, allowi… Read More
2024-04-02 06:01
Increased Focus on Artificial Intelligence (AI) and Machine Learning (ML) AI and ML technologies are poised to be more prominent in identifying and assessing risks across the device lifecycl… Read More
2024-04-02 05:40
Importance of Quality Care High-quality care leads to a range of positive outcomes for patients, healthcare systems, and society as a whole: Improved Patient Health: Effective treatments lea… Read More
2024-04-02 05:24
Join us for an eye-opening webinar on Understanding the Cost of Quality! Understanding the cost of quality is absolutely crucial for companies! It’s all about meeting consumer demands… Read More
2024-03-29 11:33
In the realm of Quality Management Systems (QMS), the adoption of a risk-based approach has become increasingly imperative. In the context of QMS, risk can be defined as the likelihood of an… Read More
2024-03-29 11:14
Role of data analytics tools Data analytics tools play a crucial role in gaining insights into customer experience and complaints by processing, analyzing, and interpreting vast amounts of d… Read More
2024-03-29 04:16
History, Evolution, and Applicability of Part 11 First published in 1996, Part 11 has been evolving to keep pace with technological changes and the manufacturing processes that go into devel… Read More
2024-03-28 12:29
Examples of using cloud-based inspection management systems Cloud-based inspection management systems find uses across various industries; here are a few examples: Construction: Inspectors c… Read More
2024-03-28 10:22
Explanation of Non-Conformances Non-conformances in ISO 9001 refer to instances where an organization’s processes, products, or services do not meet the requirements specified by the s… Read More
2024-03-28 09:28
Post-Market Surveillance and Vigilance Post-market surveillance (PMS) and vigilance are critical components of the quality management system outlined in ISO 13485. They refer to the systemat… Read More
2024-03-27 06:06
The need for innovation, shorter time to market, compliance, and lower manufacturing costs are compelling businesses to turn to digital transformation for their key processes. One such digit… Read More
2024-03-27 05:01
The post Medical Device & Manufacturing MINN appeared first on ComplianceQuest QHSE Solutions Read More
2024-03-27 05:00
The post Medical Device & Manufacturing South appeared first on ComplianceQuest QHSE Solutions Read More
2024-03-27 04:57
The post The Quality Show South appeared first on ComplianceQuest QHSE Solutions Read More
2024-03-27 04:45
The post Interphex appeared first on ComplianceQuest QHSE Solutions Read More
2024-03-27 04:43
The post 40th Society of Quality Assurance Annual Meeting & Quality College appeared first on ComplianceQuest QHSE Solutions Read More
2024-03-27 04:39
The post Parenteral Drug Association Annual Meeting appeared first on ComplianceQuest QHSE Solutions Read More
2024-03-27 04:35
The post Healthcare Information Management Systems Society 2024 appeared first on ComplianceQuest QHSE Solutions Read More
2024-03-27 04:30
The post ASQ Lean Six Sigma Conference appeared first on ComplianceQuest QHSE Solutions Read More
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A Blueprint for an Effective and Efficient Remote Audit Process - ComplianceQuest QHSE Solutions
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