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.

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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.

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Pharmaceutical Industry FDA Compliance Regulatory Compliance 88

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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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. Global Harmonization: CIOMS-I report mappings are harmonized with E2B reports, enhancing report accuracy and comprehensiveness.

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Regulatory Compliance Compliance FDA 97

HIT Consultant

OCTOBER 10, 2024

Through this, PharmaWatch ensures that patients receive safe and effective medications and helps businesses stay away from expensive recalls or non-compliance penalties. Medications should be made, stored, and sent out according to strict regulations set by global health officials like the FDA and the European Medicines Agency (EMA).

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Regulatory Compliance Compliance FDA 111

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.

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Regulatory Compliance Compliance FDA 52

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

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.

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Dot Compliance

FEBRUARY 5, 2025

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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Compliance Pharmaceutical Industry Regulatory Compliance FDA 59

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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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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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.

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Hospitals Patient Satisfaction Regulatory Compliance FDA 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

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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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

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

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

JANUARY 22, 2025

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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Compliance Regulatory Compliance FDA Licensing 59

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

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.

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Regulatory Compliance FDA Compliance 96

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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Dot Compliance

JUNE 16, 2022

Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance.

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FDA Regulatory Compliance Compliance Governance 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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Healthcare IT Today

JUNE 7, 2023

DSI and Predictive Models ONC is clearly attempting to leverage its certification program to help the Food and Drug Administration (FDA) increase transparency related to decision alerts, but this seems to be an inefficient and burdensome application of the certification lever.

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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.

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Regulatory Compliance FDA Compliance Hospitals 59

Exeed Regulatory Compliance

MARCH 9, 2020

Here is an update on recent FDA activities. Cybersecurity of medical devices is on FDA’s radar! Just last week, the FDA issued a safety communication about the recently identified SweynTooth family of cybersecurity vulnerabilities which may affect medical devices. Please click on the video link below.

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FDA Regulatory Compliance Compliance 52

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.

Medical Device Industry 59

Medical Device Industry Regulatory Compliance Compliance FDA 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.

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HIPAA Regulatory Compliance Hospitals FDA 98

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).

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Pharmaceutical Industry Regulatory Compliance FDA Compliance 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

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. What’s the Big Deal about CAPA?

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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. What’s the Big Deal about CAPA?

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Pharmaceutical Industry Regulatory Compliance Compliance FDA 52

Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.

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Dot Compliance

JANUARY 4, 2022

For manufacturers the challenges of developing connected devices range from connectivity to regulatory compliance, but perhaps most important is cybersecurity. Use it to establish a credible, comprehensive data source for proactive, predictive quality management and effective AI application.

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Verisys

NOVEMBER 30, 2022

Excluded from one means excluded from all, and the fines for non-compliance will likely be in the hundreds of thousands. Our FACIS database of more than 10 million records makes it easy to maintain regulatory compliance by identifying red-flag behaviors and trends for any individual you employ from 5,000+ sources. 52 AG Sources.

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Medicare Medicare Regulatory Compliance Medicaid 52

Dot Compliance

JANUARY 24, 2023

Regulatory compliance It seems obvious that an eQMS should enable your company to comply with FDA and global regulations, but don’t take it for granted. With visibility into their quality operations and data, you can enforce your company’s quality standards and quickly take action to prevent deviations and subsequent failures.

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