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Everything You Need to Know about Batch Manufacturing Record (BMR) Reviews

Dot Compliance

Compliance Assessment Check against regulations: Ensure the BMR complies with relevant regulatory requirements, such as FDA, GMP, or ISO standards. Document retention: Ensure that BMRs and related documents are retained for the required period, as specified by regulatory requirements.

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Understanding the FDA Debarment List

Compliancy Group

As a healthcare business owner, staying compliant with regulatory requirements is essential to the success and positive reputation of your business. One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry.

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What Makes an eQMS Stand Out? 8 Key Elements

Dot Compliance

Regulatory Compliance Industry Standards: Verify that the eQMS meets the requirements of relevant industry standards and regulations (e.g., ISO 9001, FDA 21 CFR Part 11, ISO 13485 ). Regulatory Updates: Assess the vendor’s commitment to staying updated with evolving regulatory requirements.

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10 Reasons eQMS Solutions are Critical in Pharma

Dot Compliance

These systems are designed to help pharma companies comply with regulatory requirements and standards such as 21 CFR Part 11, ISO 14971 as well as guidelines set forth by regulatory agencies like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Sign up for a demo to see the eQMS in action today.

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How Is Healthcare Incident Management Software Used?

MedTrainer

Regulatory Compliance. Organizations like The Joint Commission (TJC), Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), and Occupational Safety and Health Administration (OSHA) require incident reporting and response documentation as part of regulatory compliance.

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How Is Healthcare Incident Management Software Used?

MedTrainer

Regulatory Compliance. Organizations like The Joint Commission (TJC), Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), and Occupational Safety and Health Administration (OSHA) require incident reporting and response documentation as part of regulatory compliance.

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What Is an eQMS (and Why Life Sciences Organizations Need One)

Dot Compliance

Just a few of the core benefits include: Ensuring Regulatory Compliance Organizations within the life sciences operate within a highly regulated environment, one that is subject to stringent regulations to ensure all products are of the highest possible level of quality.