Qualifyze secures funds to transform pharma supply chain compliance
Pharmaceutical Technology
AUGUST 22, 2023
Qualifyze has secured $12m to improve supply chain compliance in the pharmaceutical sector using technological and audit data.
Compliance Related Topics 
Compliance standards in medicines are evolving rapidly. How can CDMOs keep up?
Pharmaceutical Technology
JUNE 23, 2023
CDMOs face growing challenges to keep up with QA and compliance. The regulatory framework governing medicine development is in flux.
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The criticality of compliance
pharmaphorum
OCTOBER 12, 2022
Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.
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NABL issues clarification on CAB combined ILAC MRA mark for effective compliance
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2023
The National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued clarification on NABL accredited Conformity Assessment Body (CAB) combined International Laboratory Accreditation Co-operation (ILAC) Mutual Recognition Arrangement (MRA) mark for effective compliance.
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Is Apple that naive when it comes to compliance?
World of DTC Marketing
SEPTEMBER 12, 2022
There are many reasons for non-compliance and non-adherence: Cost and affordability, lack of understanding/comprehension of advice, language barriers, cognitive abilities, fear of asking for clarification, or other reasons. The post Is Apple that naive when it comes to compliance? Oh, to live in an ideal world.
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What is Going on in Billing Compliance for Clinical Trials?
ACRP blog
JUNE 30, 2023
Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. She concluded that “a proactive approach to clinical trial billing compliance can help mitigate these risks.”
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Altro Pharmaceuticals, LSPedia Team Up on DSCSA Compliance
Pharmaceutical Commerce
JULY 25, 2023
With FDA’s compliance deadline only three months away, the tech-supply chain partnership is expected to help manufacturers and wholesalers meet the Nov. 27 deadline.
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5 HIPAA Compliance Tips For Healthcare Professionals
Pharma Mirror
JANUARY 3, 2022
They can deal with other healthcare franchises, which also need compliance. There are more reasons why health professionals should have a HIPAA compliance program in their clinics and offices. The post 5 HIPAA Compliance Tips For Healthcare Professionals appeared first on Pharma Mirror Magazine.
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Healthcare data management: resolving consent, compliance, and privacy issues
Pharmaceutical Technology
OCTOBER 25, 2022
Furthermore, data regulations around the world add another burden of compliance and need careful management. A customised solution to ensure data regulation compliance. With the rush to ensure GDPR compliance in 2018, Jackson says that many companies purchased off-the-shelf software to meet requirements.
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Pfizer faces whistleblower lawsuit from former compliance manager who says he flagged possible fraud in China
Fierce Pharma
AUGUST 10, 2023
After Pfizer allegedly fired a compliance manager for raising the flag on potential fraud activity in China, the former employee is hitting back. Frank Han, Pfizer's former director of global compliance analytics, has filed a civil complaint against the drugmaker.
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How pharma can improve regulatory compliance with AI-based technology
pharmaphorum
AUGUST 1, 2023
How pharma can improve regulatory compliance with AI-based technology Mike.Hammerton Tue, 01/08/2023 - 08:00 Bookmark this
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The Transformative Power of Generative AI in eTMF: Enhancing Efficiency, Quality, and Compliance
Cloudbyz
JUNE 5, 2023
In the fast-paced world of clinical research, managing essential Trial Master Files (TMFs) efficiently, while ensuring quality and compliance, is paramount. In this blog, we will explore how generative AI can revolutionize electronic Trial Master File (eTMF) management, unlocking new levels of efficiency, quality, and compliance.
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Clinical Trial Data Archiving: Ensuring Efficiency, Compliance, and Accessibility
Cloudbyz
JUNE 16, 2023
Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Purpose of Clinical Trial Data Archiving: Compliance: Regulatory authorities require clinical trial data to be retained for a specific duration to demonstrate compliance with guidelines and regulations.
Clinical Trial Training: In Search of Efficiency and Compliance
WCG Clinical
SEPTEMBER 7, 2023
This investment supports efficient site activation; it also maintains compliance as new site staff are brought on board and allows existing staff the opportunity to refer to the training should questions arise. Supports compliance by ensuring documentation is consistently available. Request a consultation today.
Mastering 21 CFR Part 11 Compliance: A Comprehensive Guide for Clinical Trials in the Digital Age
Cloudbyz
JUNE 10, 2023
21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Food and Drug Administration (FDA).
Compliance to convenience: understanding the latest innovations in capsule formulation
Pharmaceutical Technology
AUGUST 22, 2022
Fixed-dose combination (FDC) systems aim to increase patient compliance in therapies involving two or more active drugs. The post Compliance to convenience: understanding the latest innovations in capsule formulation appeared first on Pharmaceutical Technology. To find out more about Procaps softgels, download the whitepaper. [1]
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A Comprehensive Guide to Pharmacovigilance Regulatory Reporting: Ensuring Patient Safety and Compliance
Cloudbyz
APRIL 25, 2023
This comprehensive guide delves into the essentials of pharmacovigilance regulatory reporting, highlighting its significance in maintaining drug and device safety, and ensuring compliance with regulatory requirements. Different types of reports have specific timelines for submission, and delays may result in regulatory actions or penalties.
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Hidden compliance risks for life sciences companies
pharmaphorum
MAY 4, 2021
The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson. A decade ago, life sciences firms were early adopters of robust compliance technology — far ahead of other industries.
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The Compliance and Clinical Research Connection
ACRP blog
JANUARY 11, 2023
Compliance can feel like a mild distraction at best, or a mass of red tape that slows forward progress. Health Care Compliance Association® (HCCA®) was established to do just that. As a nationally recognized association, HCCA is the authority on healthcare compliance and ethics, so you don’t have to be.
Seed round of $2.25M secured for LighthouseAI's compliance product suite
Outsourcing Pharma
AUGUST 14, 2023
LighthouseAI a company that specializes in compliance solutions for the pharmaceutical supply chain has announced a $2.25 million seed round, led by Healthy Ventures with participation from Bertelsmann Next.
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WHO cough mixture health alerts raises questions about slack compliance in manufacturing
Pharmaceutical Technology
MARCH 30, 2023
Concern about excipient compliance One key question is whether there is a lack of enforcement of compliance at manufacturing facilities which has caused these situations or allowed issues to go undetected. If there is, as appears to be the case, then how are the relevant authorities going to ensure it doesn’t happen again?
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What is Going on in Billing Compliance for Clinical Trials?
ACRP blog
JUNE 30, 2023
Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. She concluded that “a proactive approach to clinical trial billing compliance can help mitigate these risks.”
Pay Transparency Backlash: the Harm of Reluctant Compliance
BioSpace
FEBRUARY 26, 2023
Pay Transparency Backlash: the Harm of Reluctant Compliance 2/27/2023
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Hidden Causes of Clinical Trial Retention and Compliance Issues
Imperical Blog
APRIL 11, 2023
This final installment explores clinical trial retention and compliance. Are you waiting too long to begin planning patient retention and… The post Hidden Causes of Clinical Trial Retention and Compliance Issues appeared first on Imperial Clinical Research Services Blog. Part one is here, and part two is here.
Hidden Causes of Clinical Trial Retention and Compliance Issues
Imperical Blog
APRIL 11, 2023
This final installment explores clinical trial retention and compliance. Are you waiting too long to begin planning patient retention and… The post Hidden Causes of Clinical Trial Retention and Compliance Issues appeared first on Imperial Clinical Research Services Blog. Part one is here, and part two is here.
Data Integrity and Compliance With CGMP
Pharma Tutor
JULY 9, 2022
Data Integrity and Compliance With CGMP. Read more about Data Integrity and Compliance With CGMP Log in or register to post comments Read more about Data Integrity and Compliance With CGMP Log in or register to post comments Data integrity refers to the completeness, consistency, and accuracy of data. Sat, 07/09/2022 - 16:51.
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Interview with Indegene: Challenges and future of pharmacovigilance (PV) Compliance
Outsourcing Pharma
APRIL 11, 2023
OSP spoke to Vladamir Penkrat, head of safety and regulatory and Shuba Rao a senior director at Indegene, a life sciences digital company about a paper they recently published called 'Challenges and Future of PV Compliance' about the direction compliance is headed and how they would convert risk-based approaches into a confidence-based assurances. (..)
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A Message to Pharma CIOs: Optimizing Salesforce Improves Security and Compliance
pharmaphorum
FEBRUARY 4, 2021
However, issues like compliance, governance and security often are. These problems tend to be the most severe in the oldest and largest Salesforce orgs, and can result in slow performance, reduced agility, sluggish adoption, misalignment and even compliance and security issues. Security, Governance and Compliance are important .
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A Holiday Surprise; FTC Published Its Health Products Compliance Guidance
FDA Law Blog
JANUARY 10, 2023
20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). By Riëtte van Laack & Ricardo Carvajal — On Dec. FTC staff prepared the new Guidance to update and replace Dietary Supplements: An Advertising Guide for Industry , issued in 1998 (“1998 Guidance”).
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Clinical Trial Data Management Audit Checklist and Best Practices: Ensuring Data Integrity and Compliance
Cloudbyz
MAY 24, 2023
Clinical trial data management audits serve as a critical tool to evaluate and validate the accuracy, completeness, and integrity of the data, as well as compliance with regulatory requirements. Regulatory Compliance: Verification of compliance with applicable regulatory guidelines (e.g., auditors, regulatory authorities) 2.13.Regulatory
Hand Hygiene Compliance Rate During the COVID-19 Pandemic
JAMA Internal Medicine
APRIL 25, 2021
This quality improvement study assesses hand hygiene compliance rates in a hospital with an automated hand hygiene monitoring system during the COVID-19 pandemic.
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Generating Valuable Intelligence from Life Science Compliance Data
Pharmaceutical Commerce
MAY 8, 2023
How maximizing the value of compliance data can help drive commercial decisions.
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As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever
pharmaphorum
JULY 21, 2022
With attention and resources focused elsewhere during the pandemic, it’s likely that many facilities may have slipped into a state of non-compliance, which may result in unsuccessful inspections. Doing so means that businesses can check their compliance before an FDA inspection. She has a Ph.D.
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Beginner’s Guide to 21 CFR Part 11 Compliance
Advarra
SEPTEMBER 8, 2022
After platform review, if a decision is made to validate, staff should generate documentation to ensure Part 11 compliance. As the first requirement in Part 11 compliance, validation is systematic documentation for a system’s requirements. The post Beginner’s Guide to 21 CFR Part 11 Compliance appeared first on Advarra.
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How to address 21 CFR Part 11 compliance requirements when considering ChatGPT in Clinical Trial Operations
Cloudbyz
APRIL 14, 2023
Training should cover 21 CFR Part 11 compliance requirements, system functionality, and the organization’s policies and procedures related to electronic records and electronic signatures. Vendor Compliance: If ChatGPT is provided by a third-party vendor, ensure that they meet the requirements of 21 CFR Part 11.
Achieve compliance through year-end pharma annual requirements
Bio Pharma Dive
AUGUST 9, 2021
Receive drug conversion and submission services by our expert staff, to remain compliant with the FDA.
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Anne Walsh to Moderate FDLI Compliance and Enforcement Panel
FDA Law Blog
DECEMBER 2, 2021
s Anne Walsh will be moderating “Updates in Litigation Risks: Product Liability, Private Litigation, and Consumer Class Actions,” at the upcoming Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10. Hyman, Phelps & McNamara, P.C.’s
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What US trial sponsors should know about the GDPR
Bio Pharma Dive
JULY 3, 2023
iliomad Health Data can help you maintain GDPR compliance. What is the GDPR and why does it matter to your life sciences company.
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Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11
Cloudbyz
MAY 17, 2022
To ensure continued compliance to these regulations, it is imperative for clinical researchers to understand the similarities and differences between these regulations. The post Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11 first appeared on CLOUDBYZ.
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Nutra Pharma Provides Business and Compliance Updates
BioTech 365
JULY 26, 2021
Nutra Pharma Provides Business and Compliance Updates Nutra Pharma Provides Business and Compliance Updates Nutra Pharma is providing updates regarding their business plans, accounting and compliance Plantation, Florida, July 26, 2021 (GLOBE NEWSWIRE) — Nutra Pharma Corporation (OTC Pink: NPHC), … Continue reading →
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EVALUATION OF PROCESSED FOOD ACCEPTANCE AND ITS REGULATORY COMPLIANCE IN ASIAN COUNTRIES
Pharma Tutor
NOVEMBER 14, 2022
EVALUATION OF PROCESSED FOOD ACCEPTANCE AND ITS REGULATORY COMPLIANCE IN ASIAN COUNTRIES. Mon, 11/14/2022 - 17:09. Avdesh Thassu. MPharm (Nat. Associate Vice President. Global Regulatory Affairs, Emami Limited athassu@hotmail.com. Articles.
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Experts to come together for compliance event ‘validation ready’ global labeling systems
pharmaphorum
APRIL 28, 2021
Experts to come together for compliance event . Speakers at the 24 May 2021 event entitled ‘True Validation Ready Labeling – What it Really Means’ include Phil Dray, Test Manager at PRISYM ID, and two further independent experts who have long experience in cloud-based systems and regulatory compliance. . .
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Informa Connect’s Compliance Congress for Specialty Products
Drug Channels
APRIL 19, 2021
Informa Connect’s Compliance Congress for Specialty Products. June 22-24, 2021 | Virtual Event www.informaconnect.com/specialty-compliance/. Up your compliance game at this important event serving the unique sector of Specialty Products, the 7th annual Virtual Compliance Congress for Specialty Products.
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Sharps Compliance Announces Change to Board of Directors
BioTech 365
MAY 24, 2021
Sharps Compliance Announces Change to Board of Directors Sharps Compliance Announces Change to Board of Directors HOUSTON, May 24, 2021 (GLOBE NEWSWIRE) — Sharps Compliance Corp.
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