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.

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance Regulatory Compliance FDA 52

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?

FDA 98

FDA Compliance Governance Public Health 98

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.

FDA 52

FDA Compliance Regulatory Compliance 52

Dot Compliance

FEBRUARY 23, 2024

Their tasks included documenting quality processes, obtaining signatures from authorized individuals, and storing documents for regulatory compliance. Choose an eQMS provider with proven life sciences industry expertise and a platform preconfigured to industry standards like FDA, ISO, and GxP.

FDA 52

FDA Regulatory Compliance Compliance 52

Dot Compliance

SEPTEMBER 11, 2022

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. Computer Systems That Require Compliance to 21 CFR Part 11. A wise investment, indeed.

Compliance 52

Compliance FDA Regulatory Compliance 52

Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

Dot Compliance

MAY 3, 2022

fully validated and pre-configured with best practices that meet FDA, ISO and GxP regulations. A system with workflows that are built in accordance with regulatory guidelines helps ensure the manufacturer is taking all the necessary steps for compliant change management. MES, SQM, PLM, etc.), Align Stakeholders. Gain Visibility.

Compliance 52

Compliance Regulatory Compliance FDA 52