ISPE

JULY 24, 2023

Local Hosting vs. Cloud Security: Confidentiality, Integrity, and Availability When evaluating the security of a software application, there are three important elements to consider, collectively known in the security industry as the “CIA Triad.” Confidentiality refers to how data is protected from disclosure or unauthorized access.

Communication 98

Communication Documentation 98

pharmaphorum

SEPTEMBER 29, 2022

Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA regulates mHealth technologies that are medical devices, but the agency has adopted a risk-based approach to regulating mHealth technologies, such as medical device software. not a medical device, ii. General Wellness Products.

FDA 100

FDA Documentation 100

pharmaphorum

SEPTEMBER 28, 2022

In general, the findings of the report were positive in terms of the potential of the model, which is designed to address the difficulty of regulating continuously-updating software products using FDA’s existing frameworks. But stay tuned in that space because this is an example of a new technology that we’re excited about.”.

FDA 134

FDA Documentation 134

pharmaphorum

FEBRUARY 11, 2022

Komodo Health’s president and co-founder, Web Sun, tells us about his company’s new partnership with the Chan Zuckerberg Initiative (CZI) to improve early diagnosis and advance research of rare diseases by providing CZI’s Rare as One Network healthcare data and software. For us, it’s operating at the intersection between data and software.

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101

ISPE

AUGUST 17, 2023

In the recent update to ICH Q9(R1) regulators have pointed to the main key update being: "The application of digitalization and emerging technologies in the manufacture and control of drug (medicinal) products can lead to risk reduction, when such technologies are fit for their intended use.

Documentation 98

Documentation 98

European Pharmaceutical Review

MARCH 20, 2024

According to a report by Arizton, the Europe laboratory information management system (LIMS) market is expected to reach $912.47 The impact of technology innovation Demand for lab automation is also driving growth of the European LIMS market. million by 2028. The market is growing at a CAGR of 10.16

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95

ISPE

OCTOBER 27, 2022

Challenges & Opportunities in Emerging Digital Health Technologies. Challenges & Opportunities in Emerging Digital Health Technologies. More broadly, a DHT may refer to a system that uses computing platforms, connectivity, software, and sensors for health care and related uses. Trudy Patterson. Thu, 10/27/2022 - 16:20.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

European Pharmaceutical Review

FEBRUARY 28, 2023

When I asked why they simply said the software doesn’t integrate. To achieve data integration, we must first address the data standards issues…research labs must carefully consider the software they use to create their data and what formats they can produce it in.” What technologies are needed for the ‘lab of the future’?

Documentation 94

Documentation 94

ISPE

OCTOBER 27, 2022

Challenges & Opportunities in Emerging Digital Health Technologies. Challenges & Opportunities in Emerging Digital Health Technologies. More broadly, a DHT may refer to a system that uses computing platforms, connectivity, software, and sensors for health care and related uses. Trudy Patterson. Thu, 10/27/2022 - 16:20.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

The FDA Law Blog

OCTOBER 31, 2022

Lenz, Principal Medical Device Regulation Expert — FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). By Adrienne R. As part of the pilot program, FDA included a Test Plan.

FDA 72

FDA Documentation Communication 72

pharmaphorum

AUGUST 9, 2021

Australian telecommunications giant Telstra has reached a deal to acquire MedicalDirector, a company specialising in software used by GPs to manage their practices. The company has also been expanding its business internationally, primarily in the UK where it was awarded an NHS contract to provide its cloud software to GPs in 2019.

Hospitals 104

Hospitals 104

Roots Analysis

MARCH 1, 2024

In order to effectively combat the problems related to counterfeit medicines, several companies have come up with innovative technologies to provide the necessary tools to manufacturers, healthcare professionals and patients to authenticate pharmaceutical products. Such technologies have been shown to have highly secured features.

Packaging 52

Packaging Labelling 52

European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.

FDA 122

FDA 122

The FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. smartphones and tablets) for remote data acquisition in a clinical investigation.

FDA 105

FDA Documentation 105

The FDA Law Blog

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs).

FDA 98

FDA Documentation Labelling 98

ISPE

JUNE 26, 2023

The Process Analytical Technology (PAT) concept can thus be fully realized. Iacovelli stressed and Buendia concurred that digitization should be preceded by well-developed business cases that clearly define the purpose, target, and business value, then the “people aspects” of the change, and finally, the supporting technology.

FDA 97

FDA 97

Omnicell

JANUARY 10, 2023

David Kirkus PharmD, Director of Consulting Services, EnlivenHealth Pharmacies use cutting-edge digital technologies to enhance patient engagement, maximize revenue performance, and deliver high-value clinical services. To manage their time more efficiently, Harps turned to technology to help them provide better care for their patients.

Immunization 96

Immunization Omnicell Community Pharmacies Communication 96

pharmaphorum

MAY 18, 2022

That included the use of artificial intelligence algorithms in software as a medical device (SaaMD) products, a precertification pilot programme for software, and guidance on wireless medical devices and cybersecurity. — Bakul Patel (@_bakulpatel) May 16, 2022.

FDA 138

FDA 138

European Pharmaceutical Review

FEBRUARY 13, 2023

Tokyo researchers have developed a new analytical platform based on liquid chromatography, mass spectrometry and software analysis that quantifies the structure of messenger RNA (mRNA)-based medicines. Methods are now needed to perform quality control of this new technology in a more effective, efficient way.

Immunization 103

Immunization Labelling Vaccines 103

indispensable health

AUGUST 18, 2023

Harnessing the power of technology to streamline workflows, eliminate unnecessary steps, and empower nurses to provide the best care possible while safeguarding their well-being. Technology offers a lifeline by automating documentation, report generation, and data entry: A. The solution?

Data Entry 52

Data Entry Communication Medication Dispensing Patient Care 52

The FDA Law Blog

MAY 4, 2023

DCTs often include the use of digital health technologies (DHTs), which is technology that can be used to remotely capture and transmit health care information. activity trackers, glucose monitors) and software (e.g., activity trackers, glucose monitors) and software (e.g., DHTs include monitoring instruments (e.g.,

FDA 59

FDA 59

Omnicell

JANUARY 10, 2023

Fortunately, system-oriented technologies have also advanced, making "systemness" or systemic cooperation a more achievable goal. From institutional operations and data management to technological resources and care providers, systemness is all the components of healthcare working together as one. Technology is just one component.

Omnicell 98

Omnicell Patient Care Compounding 98

pharmaphorum

AUGUST 16, 2020

Built on an agile technology platform, Swittons devices are easy to deploy within pharmaceutical laboratories of all types. The Swittons software platform is designed to provide life sciences companies with a modern, flexible user interface that not only integrates with other systems, but other IoT devices as well. Open SOP software.

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122

pharmaphorum

SEPTEMBER 15, 2022

The potential for technology to transform the way we deliver healthcare is nothing new. But the area where I believe technology can have the greatest impact – and where there is still plenty of work to do – is women’s health. These tools enable women to have more informed conversations with healthcare professionals.

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101

pharmaphorum

OCTOBER 11, 2022

million (around $2 million) in financial support for UK health technology assessment (HTA) agency NICE and medicines regulator MHRA to develop guidance on “appropriate, risk-proportionate regulation of digital mental health products” that will provide structure to the emerging market. The healthcare charity is providing £1.8

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European Pharmaceutical Review

NOVEMBER 15, 2022

Given the rapid acceptance of ‘as-a-service’ software models and significant outsourcing of previously in-house IT functions, there was a feeling that there was a need to assess and update the guidance. The validation of commercially available software applications has largely followed the GAMP V-model.

Documentation 88

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 88

pharmaphorum

JUNE 10, 2022

Pharmacos are no longer merely solving distribution and patient education challenges; they are full-fledged partners in a complex and multi-disciplinary patient journey reimagined by digital technologies. Learning requires investment, both to build new digital technologies and capabilities and to partner to acquire them.

Patient Care 131

Patient Care 131

European Pharmaceutical Review

DECEMBER 4, 2023

The most recent advances in PAT and associated technologies are further improving knowledge transfer and accessibility from R&D all the way to full-scale production plants. The Fourier PAT includes a Fourier 80 compact NMR analyser equipped with a synTQ NMR dadpter that enables the integration with synTQ PAT knowledge management software.

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94

pharmaphorum

JUNE 16, 2021

Many R&D teams have developed their own combination of partially or fully customised software and automation systems to better tackle these complexities, but overall movement of the industry towards such digital transformation has still been slow. So what is stopping the industry from adopting new ways of working?

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113

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmaceutical Technology has listed the top patient adherence pharmaceutical companies based on our intel, insights and decades-long expertise in the sector. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. Patient adherence.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

pharmaphorum

MARCH 2, 2021

Clinical trial software facilitates clinical trials from conception to finish. The industry is now recognizing that to stay ahead of competitors, technological cloud-based clinical trial software solutions are key for faster, more efficient clinical trials. Types of clinical trial software. What is a CTMS?

Patient Care 113

Patient Care FDA 113

pharmaphorum

JANUARY 27, 2023

However, one solution that can help mitigate current feelings of burnout is through the integration of precision technologies like artificial intelligence (AI). Instead, the staff is relied upon to identify this type of pertinent information. About the author Marie E.

Medical Records 108

Medical Records Patient Care Hospitals 108

IDStewardship

JUNE 6, 2023

So, fasten your seatbelts, dear readers, as we embark on an AI-powered adventure that will leave you with a newfound appreciation for the incredible synergy between humanity and technology. This empowers patients to make informed decisions and fosters better medication adherence. Let’s dive right in!

Prescription Filling 130

Prescription Filling Patient Care Hospitals Medication Dispensing 130

pharmaphorum

JUNE 1, 2022

Medical imaging specialist Median Technologies has launched a new business unit that will provide decision-making tools – underpinned by artificial intelligence – for sponsors of clinical trials in oncology. The post Median Tech debuts AI-focused unit for cancer trial support appeared first on.

FDA 95

FDA 95

Pharmaceutical Technology

OCTOBER 13, 2022

Asset finance businesses are inherently complex, so when it comes to implementing new software, there’s a lot that can go wrong. Outdated technology forces businesses to work within its constraints, instead of doing what’s best for the business. Explaining the why of new software. Michael Mousdale, project manager at Alfa.

Customer Service 52

Customer Service Communication 52

pharmaphorum

APRIL 11, 2022

He explains that VivoSense® software is designed to deliver real-world evidence from wearable sensors, which will help to advance patient-focused drug development and precision medicine for patients with cancer, Alzheimer’s, rare disease and other therapeutic indications. In this way, you’re eliminating that variability.”. Tabakin agrees. “In

Pharmaceutical Companies 109

Pharmaceutical Companies Pharmaceutical Companies Packaging 109

The Happy PharmD

JANUARY 13, 2023

As healthcare evolves, technology evolves with it. An IP is an intersection between pharmacy and health information technology (HIT). Contribute to the transformation of healthcare IT by analyzing, designing, implementing, maintain, and evaluating information and systems. Software skills are near a must for IPs.

Communication 52

Communication Medical Records Patient Care 52