Dot Compliance

FEBRUARY 5, 2025

These records are essential for ensuring consistency, safety, and compliance in the pharmaceutical industry. Each step in the process plays a role in maintaining compliance and preventing product recalls, making BMR review a vital part of quality assurance. Equipment Calibration: Documentation of equipment calibration and maintenance.

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Compliance Pharmaceutical Industry Regulatory Compliance FDA 59

Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

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FDA Malpractice Regulatory Compliance Health Insurance 288

Dot Compliance

APRIL 11, 2025

The life sciences industry is highly regulated and patient-centric, making compliance a critical component for all companies involved in the manufacture or distribution of these products. A quality management system (QMS) enables efficient processes, mitigates risks, and ensures that these products meet the highest regulatory standards.

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Regulatory Compliance Compliance FDA 52

Healthcare IT Today

JANUARY 3, 2025

AI will become fundamental to drug development processes post-discovery outside of clinical trials, like quality and regulatory compliance, because of the immediate ROI and complexity reduction it can provide. There will be no in-between. That would send shockwaves through the whole pharma industry.

Pharmaceutical Industry 88

Pharmaceutical Industry FDA Compliance Regulatory Compliance 88

HIT Consultant

OCTOBER 10, 2024

In a time when healthcare is always changing, the pharmaceutical sector is under more pressure to ensure patient safety while maintaining compliance with stringent regulatory standards. As the complexity of pharmaceutical delivery rises, technology has become ever more crucial in tracking and safeguarding pharmacological products.

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Regulatory Compliance Compliance FDA 111

HIT Consultant

JULY 10, 2024

. – These AI enhancements cater to the evolving needs of life science organizations, allowing them to navigate increasingly complex regulatory landscapes and manage rising adverse event caseloads. Streamlined Reporting: Updated report mappings simplify reporting processes and ensure compliance with current regulations.

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Regulatory Compliance Compliance FDA 97

Dot Compliance

JANUARY 22, 2025

Audit Management Audit Scheduling: Plan and schedule internal and external audits to assess compliance with quality standards and regulations. Compliance Tracking: Ensure that employees receive the necessary training to meet regulatory requirements and job responsibilities. ISO 9001, FDA 21 CFR Part 11, ISO 13485 ).

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Compliance Regulatory Compliance FDA Licensing 59

HIT Consultant

JANUARY 19, 2025

Among the key trends shaping RCM in 2025 are: Rising Costs Driven by Cybersecurity and Regulatory Compliance Demands and Increasing Patient Bad Debt Rates The cost of doing business is increasing. RCM providers invest in robust cybersecurity measures and navigate complex regulatory landscapes.

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Electronic Medical Records Regulatory Compliance Healthcare information Technology Compliance 59

Compliancy Group

NOVEMBER 4, 2024

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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FDA Compliance Officers Compliance Regulatory Compliance 52

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.

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Pharmaceutical Industry Compliance Regulatory Compliance FDA 52

Dot Compliance

NOVEMBER 20, 2023

Food and Drug Administration (FDA) to meet the Current Good Manufacturing Practice (cGMP) standards. 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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FDA Compliance Pharmaceutical Industry Regulatory Compliance 52

HIT Consultant

AUGUST 22, 2024

OneStep: Revolutionizing Remote Physical Therapy with Smartphone-Based Gait and Motion Analysis OneStep leverages smartphone motion sensors to provide continuous, clinically-validated gait and motion analysis in real-life conditions without the need for wearables.

Regulatory Compliance 98

Regulatory Compliance FDA Compliance Health Outcomes 98

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?

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FDA Compliance Governance Public Health 98

HIT Consultant

OCTOBER 15, 2024

The program includes: FDA-Cleared Wearable ECG Patch: Enables continuous monitoring of vital signs and ECG for acute care patients at home. Global Reach and Regulatory Compliance Vivalink supports HaH programs not only in the U.S. but also globally, including Canada, Australia, and the UK.

Hospitals 98

Hospitals Patient Satisfaction Regulatory Compliance FDA 98

HIT Consultant

FEBRUARY 8, 2024

Regulatory Backing for Innovation Unlearn understands the importance of regulatory compliance. They’ve partnered with experts since their inception and secured qualification from the European Medicines Agency and agreement from the US FDA, ensuring their methodology aligns with current regulations.

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Regulatory Compliance FDA Health Outcomes Compliance 97

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.

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FDA Compliance Regulatory Compliance 52

Exeed Regulatory Compliance

APRIL 2, 2020

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission. One way to understand how FDA is thinking about regulating these devices is to review recently cleared devices.

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FDA Medical Device Industry Doctors Regulatory Compliance 52

HIT Consultant

NOVEMBER 13, 2024

The development of new drugs or medical interventions is a meticulous process involving various stages to ensure safety, efficacy, and regulatory compliance. Regulatory Submissions and Approval After successful Phase III trials, sponsors submit data to regulatory authorities like the FDA or EMA for review and potential approval.

Regulatory Compliance 96

Regulatory Compliance FDA Compliance 96

Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

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COVID-19 FDA Medical Device Industry Public Health 52

Dot Compliance

JANUARY 7, 2025

With the level of regulatory scrutiny that companies face, along with customer expectations, and the complexity of products and services, organizations must excel in all operations to stay ahead. Training Management Training plan creation: Develop and manage training plans that align with organizational needs and regulatory requirements.

Medical Device Industry 59

Medical Device Industry Regulatory Compliance Compliance FDA 59

MedTrainer

JUNE 5, 2023

After years in limbo, USP <800> compliance will be required, effective November 1, 2023. It’s the first USP standard that’s enforceable by State Boards of Pharmacy, OSHA, and the FDA. What’s Needed for USP <800> Compliance?

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Compliance FDA Regulatory Compliance Hospitals 52

Dot Compliance

JUNE 16, 2022

Maintaining compliance with safety and quality standards is a significant issue in medical device manufacturing. Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance.

FDA 52

FDA Regulatory Compliance Compliance Governance 52

Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. As a result, FDA has now established additional requirements for authorization of Respirators made in China.

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COVID-19 FDA Medical Device Industry Public Health 52

Exeed Regulatory Compliance

FEBRUARY 25, 2020

Regulatory Breakthrough In a small step towards achieving the vision of interoperable medical devices, the FDA has recently authorized marketing of a novel software medical device using the De Novo Classification. the FDA expects for interoperable devices.

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FDA 52

Healthcare IT Today

JUNE 7, 2023

Many of our concerns center on the proposed implementation timeframes associated with various concepts included in HTI-1, as well as ONC’s failure to sufficiently consider the burden compliance will place on provider organizations and health IT developers. 31, 2024, compliance timeline is unrealistic.

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FDA Compliance Regulatory Compliance Medicaid 97

Exeed Regulatory Compliance

AUGUST 3, 2020

Understanding the Available Diagnostic Tests As of this writing, the FDA has authorized 187 different tests, including 154 RT-PCR molecular diagnostic tests for COVID-19. FDA allowed physicians to order one of the authorized tests if they suspected COVID-19 even when the patient did not show any symptoms. CONTACT US.

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COVID-19 FDA 52

Dot Compliance

JULY 12, 2024

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.

Pharmaceutical Industry 52

Pharmaceutical Industry Regulatory Compliance Compliance FDA 52

HIT Consultant

JANUARY 30, 2025

Food & Drug Administrations (FDA) latest guidance issued in May 2024. The FDA issued this guidance to assist service organizations in distinguishing between service activities and remanufacturing activities. laws and regulations, the FDA leveled the playing field with this new guidance. Why the New Guidance?

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FDA Compliance Regulatory Compliance 52

Dot Compliance

OCTOBER 11, 2024

It helps ensure product quality, patient safety, regulatory compliance and more. Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers.

Pharmaceutical Industry 52

Pharmaceutical Industry Regulatory Compliance Compliance FDA 52

Dot Compliance

OCTOBER 11, 2024

It helps ensure product quality, patient safety, regulatory compliance and more. Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers.

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Pharmaceutical Industry Regulatory Compliance Compliance FDA 52

HIT Consultant

SEPTEMBER 25, 2024

Regulatory Compliance and Global Presence Qure.ai’s products have received 18 FDA-cleared indications and are Class IIb certified per EU MDR regulations, ensuring the highest standards of safety and efficacy. Qure.ai’s technology powers the efficient identification and management of critical diseases.

Regulatory Compliance 59

Regulatory Compliance FDA Compliance Hospitals 59

Healthcare IT Today

AUGUST 21, 2023

FDA’s Drug Supply Chain Security Act (DSCSA). RFID’s Potential: Improved Efficiency, Safety, and Regulatory Compliance RFID technology offers significant potential for improving efficiency and patient safety in healthcare applications.

HIPAA 98

HIPAA Regulatory Compliance Hospitals FDA 98

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.

FDA 52

FDA Compliance Regulatory Compliance 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.

FDA 52

FDA Compliance Regulatory Compliance 52

Dot Compliance

MARCH 17, 2022

All while keeping in mind that compliance to regulations and global standards are non-negotiable, especially in the highly regulated life science and biotech industries. Here are key points to consider when selecting a QMS solution to support your company’s compliance and growth.

Regulatory Compliance 52

Regulatory Compliance Compliance Records Management FDA 52

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.

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Pharmaceutical Industry Regulatory Compliance FDA Compliance 52

Verisys

NOVEMBER 30, 2022

Maintaining compliance and safeguarding against fraud and abuse in today’s changing healthcare landscape can be challenging. Excluded from one means excluded from all, and the fines for non-compliance will likely be in the hundreds of thousands. OIG, SAM DEA, GSA, FDA. How many data sources is your organization monitoring?

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Medicare Medicare Regulatory Compliance Medicaid 52