Download FDA Regulatory Compliance 
Dot Compliance
FEBRUARY 22, 2022
FDA regulations govern what you can claim about your product and whether you can even sell it at all. For companies that manufacture drugs, biotechnology, and related products, demonstrating the safety and effectiveness of your goods to the FDA’s satisfaction has to be a top priority. What is the process for FDA drug approval?
Dot Compliance
JANUARY 29, 2025
Improved Compliance and Risk Management Regulatory compliance: eQMS solutions help organizations meet industry-specific regulations, such as FDA, ISO 9001 , and GMP, by providing built-in compliance features. Download our white paper, How to Choose an eQMS , for more.
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Dot Compliance
JANUARY 14, 2025
By tracking nonconformances, corrective actions, and preventive measures, businesses can improve product quality and reduce the likelihood of recalls or regulatory issues. Regulatory Compliance: eQMS can help organizations meet industry-specific regulations, such as ISO 9001, FDA 21 CFR Part 11, and others.
Dot Compliance
APRIL 11, 2025
Consider the following factors: Regulatory Requirements: Determine the specific regulations and standards that apply to your products and processes. This may include FDA regulations for medical devices or pharmaceutical products, EMA regulations for products sold in the European Union, or ISO standards for general quality management.
Dot Compliance
NOVEMBER 2, 2022
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. Without FDA notification, companies may get this paper in the mail.
Dot Compliance
MAY 3, 2024
In the pharmaceutical industry, the importance of regulatory compliance extends beyond fulfilling legal obligations. Compliance can be streamlined with the help of an electronic quality management system (eQMS) that incorporates regulatory standards into every operational aspect of a pharmaceutical organization.
Dot Compliance
JANUARY 7, 2025
Enhance compliance: Ensure compliance with FDA regulations, including CGMP and 21 CFR Part 11 , through automated compliance checks and audit trails. Enhance regulatory compliance: Comply with Good Laboratory Practices (GLP) and other relevant regulations.
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