magnifying glass search button

X

Blog

The eQMS Pulse

All Posts

Steps to Consider When Dealing With 483 FDA and Warning Letters

Regulatory Compliance

November 3rd, 2022

6 min read

The FDA sends an FDA Form 483 Observation, also known as a “inspectional observation” or “Form 483” to draw attention to any potential legal infractions discovered during a routine inspection. These are issued after a 483 FDA inspection. An FDA Form 483 Observation may concern the company’s building, tools, controls, procedures, goods, personnel conduct, or...

The FDA Ramps Up GMP Inspections

Audit

November 2nd, 2022

2 min read

Your quality management processes are under the watchful eye of the FDA and other regulators, and it is only a matter of time until you are subject to an inspection, whether planned or unplanned. As the FDA ramps up its surveillance activities to address the COVID-19 pandemic backlog, the likelihood of an inspection grows. 
News, articles, and resources, every month.

Subscribe to our newsletter

8 Key Principles of Quality Management

Best Practices

October 18th, 2022

5 min read

The 8 Principles of Quality Management are the foundation for guiding QMS Principles of ISO 9001, the most widely adopted quality standard in the world. The International Organization for Standardization, or ISO, created these guidelines, which form the cornerstone of quality and compliance. ISO 9001 gives organizations an operational framework to develop processes and procedures...

QMS 101: Medical Device Validation

Best Practices

October 10th, 2022

10 min read

The process of ensuring medical equipment will operate safely and correctly is known as medical device validation. Regional regulatory organizations and worldwide standards, which frequently overlap when it comes to product needs, determine the requirements for validation and verification. Each manufacturer employee that works on creating medical equipment must complete the necessary training. Quality assurance...

QMS 101: Quality Management System (QMS) for Manufacturing

Core QMS

October 6th, 2022

5 min read

Manufacturers may electronically monitor, control, and record their quality processes with the use of a quality management system (QMS), which helps to verify that goods are produced within tolerance, in accordance with all relevant standards, and are free from defects. The techniques, processes, structures, and resources required for streamlining manufacturing and ERP operations while controlling...

QMS 101: Pharmaceutical Quality Management System

Best Practices

September 29th, 2022

7 min read

The Pharmaceutical Quality Management System (QMS) is a collection of activities and processes that improve the quality of the pharmaceutical product. It focuses on specific persons and processes involved in the production of goods and stops them from straying from quality standards like FDA 21 CFR Part 11, ISO and ICH Q10. For instance, data...

The Ultimate Guide to 21 CFR Part 11 QMS

Best Practices

September 11th, 2022

10 min read

FDA 21 CFR Part 11 is a rule that specifies how businesses that are subject to FDA regulation, such as those in the medical device, pharmaceutical, and other industries, should manage their electronic records and electronic signatures. Organizations must abide by several rules and different sets of criteria that are specific to the life science...

The Ultimate Guide to ISO 9001 QMS

Best Practices

September 11th, 2022

6 min read

The Quality Management System (QMS) doesn’t have any independent standards. It depends on other accepted standards for its definition, application, and actual execution such as ISO 9001. It is the obligation of the firm to implement the pertinent standards, which vary depending on a variety of elements, such as location, product type, and target market....