Dot Compliance

NOVEMBER 20, 2023

In the pharmaceutical industry, ensuring the safety and quality of drugs is paramount. For companies in the manufacturing, processing, packing, or holding of drugs, compliance with 21 CFR Part 210 and 21 CFR Part 211 is not just a regulatory requirement; it’s the key to producing safe and effective pharmaceutical products.

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Dot Compliance

NOVEMBER 8, 2024

In the pharmaceutical industry, a leading Corrective and Preventive Action (CAPA) process is essential for ensuring product quality and regulatory compliance. Step 3: Risk Assessment Assess the potential impact of the identified problem on product quality, patient safety, and regulatory compliance.

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Dot Compliance

OCTOBER 25, 2024

In the pharmaceutical industry, it is essential to ensure product quality, patient safety, and regulatory compliance. By combining these two disciplines, organizations can achieve a higher level of quality and compliance. The post CAPA and Risk Management: A Synergistic Approach appeared first on Dot Compliance.

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HIT Consultant

DECEMBER 19, 2023

In addition, the strict regulatory requirements in the healthcare industry mean that IDP systems must ensure patient privacy protection and maintain audit trails. This is essential for optimizing communications with sites and ensuring regulatory compliance.

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HIT Consultant

AUGUST 16, 2023

Accelerating the Adoption of IDMP-O to Simplify and Standardise data Assets “Fluree is a perfect fit for pharmaceutical organizations seeking to balance regulatory compliance with innovation and accelerate drug discovery, efficacy and efficiency,” said Eliud Polanco, Fluree president. years, with only a 7.9%

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Healthcare IT Today

JANUARY 8, 2024

It is key for pharmaceutical companies to recognize that efficiency does not override compliance, patient safety or regulatory standards. The AI revolution has been and will continue to redefine the pharmaceutical industry in 2024, promising transformative outcomes for patients. Dave Latshaw, CEO at BioPhy 1.

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Dot Compliance

JULY 12, 2024

Implementing an electronic quality management system (eQMS) is crucial for organizations in the pharmaceutical industry. By automating and streamlining quality processes, an eQMS ensures that companies can efficiently meet these regulatory demands while improving areas like data integrity, traceability, and overall process management.

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Dot Compliance

DECEMBER 23, 2024

Corrective and Preventive Action (CAPA) plays a key role in maintaining product quality in the pharmaceutical industry, as outlined by the ICH Q10 guidelines. Learn how, by integrating these elements, companies can ensure compliance and enhance product safety. Is your solution aligned with the ICH Q10 guidelines?

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Dot Compliance

SEPTEMBER 11, 2022

The following is a list of some of the most prevalent rules and regulations that apply to the Pharmaceutical Quality Management System (QMS). Organization for International Standardization (ISO): ISO is a global organization that creates standards for a variety of sectors, including the pharmaceutical industry.

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Verisys

FEBRUARY 7, 2024

The more you know about the people in your organization, the safer you are from risks that could damage your company, your reputation, or your compliance.The regulations in the pharmaceutical industry are understandably strict, and to ensure your organization is compliant, every member of your team must be thoroughly vetted.

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Dot Compliance

JANUARY 20, 2022

As a result, pharmaceutical companies of all sizes need quality management systems built to address a slew of unique challenges and regulatory oversight. The key framework for creating a QMS that can handle the demands of the pharmaceutical industry is the International Conference on Harmonisation (ICH) Q10 model.

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Natalia Mazina

OCTOBER 22, 2023

There is even a conference on reducing environmental impact of pharmaceutical industry – Clean Med Conference. Just think of the potential impact some of these practices could make. With over 6 billion prescriptions filled each year in U.S., pharmacy environmental impact is a serious matter.

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