Indian Pharmaceutical Company Investigates Security Incident

Data Breach Today

Reddy's Laboratories Says Plants in Four Countries Affected Dr. Reddy's Laboratories, a multinational pharmaceutical company based in India that's testing a COVID-19 vaccine, says it isolated its data center services Thursday following what it calls a "detected cyberattack

IAM's Role in the Pharmaceutical Sector

Data Breach Today

Sandy Dalal of Allergan on Achieving Security Stability Mergers and acquisitions, along with cloud adoption, are rapidly changing the pharmaceutical industry. Sandy Dalal of Allergan talks about how identity and access management, along with zero trust, are bringing security stability

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Pharmaceutical companies exploited by phishing scam targeting job seekers

IT Governance

Earlier this month, two major pharmaceutical giants issued warnings about phishing emails targeting job hunters. The post Pharmaceutical companies exploited by phishing scam targeting job seekers appeared first on IT Governance Blog. GlaxoSmithKline and AstraZeneca say they are victims of recruitment scams, in which crooks create fake job adverts to obtain people’s personal and financial details.

ThreatList: Pharma Mobile Phishing Attacks Turn to Malware

Threatpost

After the breakout of the COVID-19 pandemic, mobile phishing attacks targeting pharmaceutical companies have shifted their focus from credential theft to malware delivery.

Three COVID-19 Vaccine-Makers are Under Active Attack

Threatpost

Three major APTs are involved in ongoing compromises at pharma and clinical organizations involved in COVID-19 research, Microsoft says.

Pharma Giant Pfizer Leaks Customer Prescription Info, Call Transcripts

Threatpost

Breach Cloud Security Privacy advil call transcripts cancer drugs chantix Customer Data Customer Records data breach data leak drug company exposure google cloud lyrica misconfiguration open database patient information Pfizer pharmaceuticals premarin prescriptions Viagra vpnMentor

How a global research and manufacturing company achieves regulatory compliance

OpenText Information Management

Content Services Healthcare & Life Sciences manufacturing Documentum Documentum for Life Sciences pharmaceutical Documentum for Quality and Manufacturing research and development

What’s new in OpenText Documentum for Life Sciences Cloud Edition (CE) 20.2

OpenText Information Management

Pharmaceutical and Life Sciences companies are in the public spotlight as they pursue advanced therapies and vaccines to combat the coronavirus pandemic. Content Services Life sciences Documentum for Life Sciences pharmaceutical quality management regulatory submissions virtual documents biopharma release 20.2 Productivity, flexibility and governance capabilities are more critical than ever for speeding these life-saving products to market.

Healthcare Supply Chain Security: Updated Guidance

Data Breach Today

With the escalation of cyberattacks on the healthcare sector during the COVID-19 pandemic, supply chain partners need to strengthen their security controls and defenses, say Vishwas Gadgil of pharmaceutical firm Merck and Ed Gaudet of the consultancy Censinet.

Top 5 Life Sciences predictions in 2020

OpenText Information Management

Industries Healthcare & Life Sciences Healthcare IoT Content management Interoperability the internet of things Life sciences EIM platform FDA pharmaceutical ISO IDMP Industry 4.0 With the patient taking center stage, digitization is gaining pace within Life Sciences. This blog looks at how digital technology is going to shape every stage of the drug lifecycle for life science and pharma companies in 2020.

Introducing OpenText Content Cloud for Life Sciences

OpenText Information Management

Cloud Content Services Healthcare & Life Sciences OpenText cloud Content Compliance ECM manufacturing collaboration Industry enterprise content management digital transformation Life sciences Documentum QM user experience Documentum for Life Sciences ecd eTMF pharmaceutical Quality quality documentation regulatory submission documentation regulatory submissions regulatory professionals GxP co-author co-authoring clinical regulatory virtual documents opentext content cloud for life sciences

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Safeguarding COVID-19 Research, Other Intellectual Property

Data Breach Today

As cyberthreats to medical research on COVID-19 - and other intellectual property - grow, organzations must take critical steps to prevent the theft of their "innovation capital," says Russell Koste, chief security officer of Alexion Pharmaceuticals

Fraud Detection: Lessons From Novartis Case

Data Breach Today

Compliance Expert Thomas Fox on the Role Data Analytics Can Play Incidents of fraud at pharmaceutical giant Novartis that resulted in over $1 billion in fines worldwide might have been avoided if the company's compliance team used data analytics to detect patterns, says Thomas Fox, a compliance evangelist and author.

Alert: APT Groups Targeting COVID-19 Researchers

Data Breach Today

are warning medical institutions, pharmaceutical companies, universities and others about "password-spraying campaigns" by advance persistent threat groups seeking to steal COVID-19 research data. Password-Spraying' Campaigns Aimed at Stealing Research Data, US and UK Authorities Warn Authorities in the U.S. and U.K.

Life Sciences at Enterprise World 2019

OpenText Information Management

Enterprise World Industry AI Articial Intelligence cloud Compliance Content digital transformation Documentum Documentum for Life Sciences ecd ECM enterprise content management EP6 eTMF Life sciences manufacturing mobile OpenText pharmaceutical QM Quality quality documentation regulatory professionals regulatory submission documentation regulatory submissions user experience

What’s new in OpenText Documentum for Life Sciences Release 16 EP7

OpenText Information Management

Every pharmaceutical company wants to accelerate the drug development process – from discovery to commercial success – to deliver new treatments that improve patient outcomes. At OpenText™, the Life Sciences team is committed to delivering better intelligent content services that drive productivity, growth and a lasting competitive advantage.

Tackling the ‘inconvenient truth’ of AI in healthcare

OpenText Information Management

AI & Analytics Industries Healthcare & Life Sciences AI AI in Healthcare biopharma Healthcare Life sciences pharmaceuticalThe market is growing fast for Healthcare Artifical Intelligence (AI), estimated to reach over $8 billion by 2026. During this year’s Intelligent Health conference, there was a great deal of talk about the potential of AI in healthcare, but also about its largest challenges: data integration and preparation.

Reimagining patient centricity and healthcare practitioner engagement for 2020

DXC

Life Sciences analytics healthcare pharmaceuticalby Satish Pandelenghat and Manjunath Shanabag The relationship between the life sciences industry and healthcare practitioners has changed dramatically in recent years. It wasn’t that long ago that sales reps visited each practice to provide information about new products. That changed in the late 1990s and early 2000s as information became more digital. Now what […].

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Is this the year of the patient-centric business model for healthcare?

OpenText Information Management

Industries Healthcare & Life Sciences 2020 predictions biopharma Electronic Medical Records medical devices medtech biotech AI analytics personalized medicine IoMT data platforms data integration Patient Outcomes Patient Centered FDA clinical trials Clinical Applications machine learning Life sciences the internet of things Interoperability Patient-Centric pharmaceutical identity and access management health care

ISO identification of medicinal products (IDMP)

OpenText Information Management

Enterprise Content Management Information Management EIM ISO IDMP Life sciences pharmaceuticalIn a previous blog I looked at some of the EU regulations that are disrupting the Life Sciences sector. One area of change with truly global implications is the implementation of the ISO Identification of Medicinal Products (IDMP).

Turn on a Dime with a Responsive Data Strategy

Reltio

Business MDM Cloud Partner Posts IQVIA Master Data Management MDM PharmaceuticalMaster Data Management in the Time of COVID-19. In coping with the COVID-19 pandemic, the medical community has had to adapt to a fluid situation. New scientific information is published daily.

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Introducing OpenText Life Sciences Express – it’s simple

OpenText Information Management

Enterprise Content Management clinical trials cloud application Compliance Content digital transformation Documentum Documentum for Life Sciences ecd ECM enterprise content management eTMF Life sciences mobile OpenText pharmaceutical Quality quality documentation regulatory submission documentation regulatory submissions user experieceSimplicity. That’s what every Life Sciences professional working with regulated business processes needs today.

Making Internal Audits More Relevant

Data Breach Today

Prasanna Bharatan, internal auditor at the pharmaceutical company Wockhardt, outlines the important steps to take Wockhardt's Prasanna Bharatan on Why Audits Often Are Not Meaningful How can improve internal audits be improved and made more meaningful?

Four Use Cases Proving the Benefits of Metadata-Driven Automation

erwin

Metadata-Driven Automation in the Pharmaceutical Industry. One global pharmaceutical giant headquartered in the United States experienced such issues until it adopted metadata-driven automation. Organization’s cannot hope to make the most out of a data-driven strategy, without at least some degree of metadata-driven automation. The volume and variety of data has snowballed, and so has its velocity.

What’s new in Release 19.4 for OpenText Life Sciences Express

OpenText Information Management

Cloud & Applications Industries Healthcare & Life Sciences clinical trials cloud cloud application Compliance Content digital transformation Documentum Documentum for Life Sciences ecd ECM enterprise content management eTMF Life sciences Life Sciences Express mobile OpenText pharmaceutical Quality quality documentation regulatory professionals regulatory submission documentation regulatory submissions Release 16 Release 16 EP7 user experience

Identity Verification in Healthcare: Revamping a Framework

Data Breach Today

A 15-year-old identity framework originally designed for narrow use by pharmaceutical companies is being revamped and updated for broader use in healthcare, says Kyle Neuman, managing director of SAFE Identity, an industry consortium and certification body that's coordinating the project

What’s new in OpenText Life Sciences Smart View 20.4

OpenText Information Management

This is especially critical as pharmaceutical companies continue to bring life-saving therapies to patients, including many who are racing to test the safety and effectiveness … The post What’s new in OpenText Life Sciences Smart View 20.4

The hidden threats facing your intellectual property

IT Governance

For life sciences and pharmaceutical companies, this includes data on the development and testing of new therapies and details of how therapies are manufactured. Cyber Resilience Healthcare Intellectual Property Life Sciences PharmaceuticalWhen we consider the damage a data breach can cause, we tend to focus on the cost of breach reporting, potential fines and loss of reputation.

My Health Record 'identical' to failed UK scheme, privacy expert says

The Guardian Data Protection

Health Data protection Australia news Technology Privacy Pharmaceuticals industryCare.data was cancelled because drug and insurance companies were able to buy patient data Australia’s impending My Health Record system is “identical” to a failed system in England that was cancelled after it was found to be selling patient data to drug and insurance companies , a British privacy expert has said.

Former Physician Convicted of Criminal HIPAA Violation

Data Breach Today

The case was tied to providing a pharmaceutical salesperson access to patients' medical records Case Involved Unauthorized Access to Patient Records A former Massachusetts gynecologist has been convicted in a rare case involving a criminal HIPAA violation.

Business Process Modeling Use Cases and Definition

erwin

This also extends to industry-specific other compliance mandates such as those in healthcare, pharmaceutical and the financial services industries. What is business process modeling (BPM)? A visual representation of what your business does and how it does it. Why is having this picture important? According to Gartner , BPM links business strategy to IT systems development to ensure business value.

Who Is Responsible For The Compliance Of Cloud Systems?

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyAny time you take advantage of a cloud service – infrastructure, platform, or software – for a regulated purpose, you are ultimately responsible for its regulatory compliance, not the cloud vendor.

With a focus on seamless sharing across domains, OpenText Documentum for Life Sciences 16.4 takes a giant leap forward

OpenText Information Management

Enterprise Content Management clinical trials cloud cloud application Compliance Content digital transformation Documentum Documentum for Life Sciences ecd ECM enterprise content management eTMF Life sciences manufacturing OpenText pharmaceutical QM Quality quality documentation regulatory professionals regulatory submission documentation regulatory submissions user experience

Maintaining Regulatory-Compliant Cloud Solutions

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technology

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Refresher: Which IT Systems Are Regulated

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyIf your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated.

Key Takeaways About Compliant IT Systems In The Cloud

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyThis is the final post in our series on maintaining regulatory-compliant IT systems in the cloud. In this post, we’ll go over the key takeaways from the series and then we’ll send you on your way!

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How To Qualify Cloud Vendors

Perficient Data & Analytics

Because the ultimate responsibility for regulatory compliance lies with you – the pharmaceutical or medical device company – you need to be much more proactive and critical. Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technology

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Introducing Box GxP Validation: Compliance for an Agile Cloud

Box

Organizations in the life sciences, including pharmaceuticals, biotech and medical device companies, are rapidly transforming.

How To Use Contracts For Regulatory Compliance Of Cloud Systems

Perficient Data & Analytics

Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyIn the previous post in this series, we discussed how to qualify cloud vendors.

Using a 'Privacy by Design' Approach to GDPR Compliance

Data Breach Today

To prepare for compliance with the EU's GDPR, which will be enforced beginning in May, organizations must adopt a "privacy by design" approach, says Subhajit Deb, CISO at Dr. Reddy's Laboratories, an India headquartered pharmaceutical company that does business in 11 countries