Traceability in EQMS: Understanding Critical Requirements
Traceability is becoming increasingly important for companies in various industries. Despite some misconceptions, traceability should be part of every manufacturer process, whether food, automobiles, or aircraft. Undoubtedly, it provides significant ...
7 Warning Signs That Could Trigger an FDA Warning Letter
A Warning Letter (or Form-483) of Inspectional Observations from the FDA is a nightmare for regulated businesses. Receiving a list of deficiencies can feel like a heavy blow to a quality assurance system in controlled food, agriculture, and pharmaceu...
Conflict Minerals Compliance Explained
As defined by US legislation, a conflict mineral is a metal derived from one of four minerals: tantalum, tin, tungsten, or gold. Today, a small fraction of all tin, tantalum, tungsten, and gold metals are sourced from the Democratic Republic of Congo...
Adverse Event Reporting: Key Regulatory Insights
Businesses must prioritize customer safety at all times. Even though adverse event data is valuable for improving quality systems and processes, it can be challenging without standardized reporting standards. However, Quality professionals can minimi...
Master remote audits with cloud based audit software
COVID-19 has changed the way we work for the rest of our lives. The possibility of remote work is available for an extended period to the entire staff in many organizations was never considered before the virus spread globally. Organizations are re-e...
Workplace Incident Management: Best Practices
Experiencing workplace incidents and its consequences is simply unpleasant. No one likes to face adverse events since they reflect that there is something wrong with the way we are handling things currently. This is where we need to be proactive. So,...
How EQMS Helps Manage Quality Policy Effectively
What is the Purpose of Quality Policy? Quality policies describe your company's intentions, goals, and guidelines in relation to quality. You must create one to define your company's policies that will benefit various stakeholders. Instead of just a ...
Understanding the Key Dimensions of Quality
To be successful, your business needs to maintain quality at all levels. Managing an organization is about quality, how good is the product, service, process, action, or decision, and how can it be improved? An organization's success depends heavily ...
ISO 9001 vs QMS: Key Differences Explained
ISO and QMS: An Enterprises Perspective Businesses commonly standardize their processes. The standards in a particular field are highly distilled best practices developed by experts who understand the needs of their field. For example, a standard can...
How Six Sigma Helps Achieve Quality Goals
Whether an organization succeeds or fails largely depends on the quality of its products and services. In the long run, you will not be able to survive if you ignore an important aspect like quality. Six Sigma aims to eliminate defects in processes a...
Data Fidelity and Quality Management: What's the Connection
The most valuable asset to your organization is its data. First, however, you need to be sure that the data you use is reliable and trustworthy. Companies can make reckless recommendations when they work with untrustworthy data for any reason. An ind...
7 Benefits of Building Efficient Employee Teams
Training plays a critical role in creating efficient teams that help you achieve operational excellence and business goals. The benefits of building efficient teams extend way beyond. You can build a more substantial brand reputation and significantl...
How to Design an Effective CAPA Workflow
The Corrective Actions and Preventive Actions (CAPA) process plays a significant role in achieving operational excellence. It increases customer satisfaction, improves product quality, and decreases risk, such as product recalls. Using the right CAPA...
Why You Should Audit and Improve Your NC Workflow
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 right about how your organization works. As a result, your t...
Non-Conformance vs OOS: Key Differences Explained
You may be involved in a highly regulated industry, such as medical devices, pharmaceuticals, biotechnology, or general manufacturing; companies whose control mechanisms fail to meet scientific standards cannot ensure that their testing protocols, pr...
Guide to Measure Quality Management Process Effectiveness
The quality, reliability, and efficiency of the company operations and products are factors companies consider when measuring their success. Companies can improve their products and operations by measuring the effectiveness of quality management proc...
Challenges in Healthcare Quality and Risk Management
Nowadays, healthcare services are affected by three waves of intervention and change: quality management, risk management, and patient safety. Managing risk and providing quality care is essential to any healthcare organization's longevity and fina...
Document Retention for Compliance | Essential Guide
Organizational policies must address how, where, when, and for how long corporate, employee, and client documents are handled and stored. It's a critical compliance requirement for all types of organizations. Document retention policies are not just ...
CAPA Review Training for Quality Management Teams
A CAPA is a crucial component of your compliance regime. You must have an effective CAPA management system in place to manage quality issues such that they do not reoccur. However, implementing a CAPA system is just a stepping stone. The success of...
5 Key Considerations for Implementing EQMS in Life Sciences
Have you ever wondered how some life sciences organizations manage their quality process so well, while others just feel stuck in aligning their processes, right? On top of it, the quality issues in the pipeline are just increasing. You are not the ...
Different Methods of Document Version Control
You may be compromising the efficiency and effectiveness of your business by not prioritizing comprehensive document version control. How come? Version control prevents your employees and decision-makers from acting on outdated, incomplete, and missi...
CAPA Pitfalls to Avoid for Compliance Success
When you are frequently reported about quality events, and many of them are recurring, it becomes difficult to prioritize them. You may find it challenging to decide which quality events require a detailed investigation. And you end up investing time...
Quality Assurance in Logistics | Meaning & Processes
Every organization should have a quality assurance program. Logistics companies should ensure quality assurance when implementing next-generation technologies to protect their sophisticated processes. Also, they must be able to see the entire operati...
Nutraceutical Industry Compliance | Key Strategies
In today's market, companies that wish to remain competitive and earn consumers trust must ensure quality. The nutraceutical industry is no exception, where product safety is crucial to brand success. Nutraceuticals are subject to different regulatio...
Quality Control Scope in Food and Beverage Industry
A lot of food products are susceptible. It is why the food industry must adhere to quality requirements and maintain quality standards. Food is one item we repeatedly buy from the same brand, believing that it meets our expectations and is of excelle...
Main Challenges in Data Migration and How to Overcome Them
Every year, information-intensive businesses spend billions of dollars just to migrate the data. Yet, most of the new systems do not live up to expectations, typically because migration errors lead to partially validated data. Due to the view that th...
Best Training Management Software: How to Choose Wisely
It can be overwhelming and confusing to search online for keywords like training management or & training management system. The basic idea of training management may remain the same. However, not all training management systems (TMS) are the same. T...
AS9100 Aerospace Certification: Explained
Defense, aerospace, and aviation are the world's most regulated industries. The qualification requirements for suppliers in these sectors include the compliance requirements of quality management systems, such as AS9100, AS9110, or AS9120. From desig...
Quality Management Challenges in Animal Healthcare Industry
Animal Health and Environment are unpredictably connected. In the hour of developing world human and animal populaces and quick environmental change, the linkages between human, animal, and ecological well-being are becoming more apparent. Since anim...
Integrated EQMS Software: Why It’s a Smart Investment
With the time and changing trends, businesses have started questioning the value of applications they implement to make everyday job easier. It enables them to identify the changes required in the existing approach, strategy, and tools. For example, ...
