Successful product development requires the design and development of products that address the pain points of the intended customers, serve the cost and time objectives efficiently, and mee… Read More

AI-Powered Solution Built on Salesforce ComplianceQuest’s Applied AI offers businesses support in areas such as complaints management, audit management, addressing nonconformance, CAPA… Read More

Standards and regulations such as ISO and FDA stress CAPA, referring to Corrective Action, Preventive Action, creating the impression that they are one and the same thing or a continuous pro… Read More

In today’s fast-paced business world, organizations strive for success by optimizing their operations, enhancing efficiency, and maintaining regulatory compliance. One critical aspect… Read More

 In today’s fast-paced business landscape, enterprises strive for excellence in their operations. One critical area that requires meticulous attention is nonconformance… Read More

The post Nonconformance (NC) vs. Out of Specifcation (OOS)in the Pharma Sector appeared first on ComplianceQuest QHSE Solutions Read More

Nonconformance is one of the leading reasons for medical device manufacturers receiving FDA warning letters. Regulation 21 CFR 820.90(a) establishes the FDA requirement that manufacturers mu… Read More

The journey of a product or service begins with deciding the specifications once the design concept has been set. The specifications give direction to the subsequent processes, ensuring qual… Read More

In today’s rapidly evolving technological landscape, quality management plays a critical role in ensuring the delivery of superior products and services. As we step into 2023, the fie… Read More

Small business owners and managers frequently find themselves in a difficult situation when faced with the challenge of finishing ISO 9001 certification. They know the value of having th… Read More

An organization is required by ISO 9001 to assess the necessity of taking steps to stop non-conformities from happening again. Customer complaints, bad or unfavorable results, trend… Read More

The COVID-19 pandemic exacerbated many trends, including the rise in the number of off-site safety audits. Before social distancing, off-site investigations were already becoming a more… Read More

The mixed-income proposal will revitalize 70-year-old site along Belvedere Lagoon with 42 housing units including 12 affordable residences comprised of below market-rate units, ADUs, and… Read More

For us at ComplianceQuest, the value of AI in quality and safety management is tangible. We are leveraging intelligent automation and decision support capabilities to truly and practically i… Read More

Boston, Massachusetts--(Newsfile Corp. - April 20, 2023) - Block & Leviton is investigating Spirit AeroSystems Holdings, Inc. (NYSE: SPR) for potential securities law violations. Investo… Read More

Table of Contents What are the common mistakes that people make when investigating a problem? So, why is focusing on systems and processes a better approach to root cause analysis? Can C… Read More

Table of Contents 5 Ws 5 Whys Fishbone Diagram Pareto Chart Define the problem or issue: Collect data: Determine the categories: Calculate the frequency… Read More

Table of Contents First, let’s define what it means to be a reactive organization. Consequences of being reactive Examples of reactive organizations A reactive organization ten… Read More

Table of Contents CAPA Software: What is it? CAPA Software – Why? Selecting CAPA software An Overview of the Top 5 CAPA Management Software Systems Intellect Qualityze Greenlig… Read More

Acumatica’s manufacturing solutions help companies leverage their inbuilt Good Manufacturing Practice practices across various plant operations, including formulation, production, qual… Read More

 The global quality management market is estimated to be worth US$ 13,833.2 million in 2018 and is expected to grow to US$ 25,418.9 million by 2023, at a CAGR of 12.9% over the forecast… Read More

“It is most important that top management be quality-minded. In the absence of sincere manifestation of interest at the top, little will happen below.” — Mr. Joseph M. Jura… Read More

The last thing a growing business needs is to be bogged down by regulatory breaches or legalhassles, and this is where the absolute necessity of ‘statutory compliance’ comes in… Read More

Perhaps you noticed that the production team was not meeting their deadlines. Our customer complaints have been on the rise for quite some time. No matter how you slice it, something is not… Read More

Multiple Finance Analyst Jobs in the United States of America. Read the Job Description, Responsibilities, and Qualifications and apply now. According to Wikipedia, A financial analyst i… Read More

There are a number of things that can and do go wrong on a project. You are probably familiar with many of the most common project management failures or nonconformances, but are you familia… Read More

No matter what’s the size of your company is or how reputed your organization, customer complaints are inevitable. You cannot get rid of or prevent customer complaints, but you can sur… Read More

In the previous article (Common issues in manufacturing sites – maintenance work of PCs and software), I explained the use of many PCs in manufacturing sites and their risks, and intro… Read More

Pharma Process ValidationDefinition of process validationprocess validation can be defined as scientifically establishing documentary evidence that the process adapted for manufacturing of a… Read More

In the world of compliance, there are a lot of stakes. Food and Drug Administration (FDA), the teacher, in this case, can provide you with the correct answers.  It doesn’t mean… Read More