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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. MORE
by Satish Nair and Manjunath Shanabag Pharmaceutical companies struggle with a complex and, often, poorly managed partner, customer and distribution network. It’s not surprising, given the makeup of most large pharma companies. Large, often disconnected product portfolios are built through discovery — both internally and externally with academia and biotech partners — and global clinical […]. Analytics Business Processes Life Sciences MORE
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. MORE
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. MORE
When major acquisitions happen, market analysts, competitors, customers, and employees alike are watching closely to determine what’s next. MORE
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. MORE
If you work in the Life Sciences industry, your head will be nodding in confirmation while reading Forrester’s The Five Big Trends report, especially the part that states employee productivity has emerged as the second biggest driver for ECM investment in 2019. MORE
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. MORE
Recently, Aegerion Pharmaceuticals announced that it will enter into several settlements and plead guilty to two misdemeanors in connection with alleged violations of HIPAA, drug marketing regulations and securities laws. The criminal charges stem from the company’s marketing of a cholesterol drug called Juxtapid. MORE
by Mark Wren It wasn’t long ago that healthcare and pharmaceuticals were treated as separate industries and the crossover – when it happened – was just in terms of how clinicians used drugs and devices. MORE
You can’t deliver tomorrow’s innovation if you’re still using yesterday’s business models. For Healthcare 4.0, that means designing services and solutions around patients and empowering them to take more control, becoming partners in their own healthcare. MORE
Organizations in the life sciences, including pharmaceuticals, biotech and medical device companies, are rapidly transforming. MORE
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! MORE
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 MORE
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. MORE
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. MORE
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 MORE
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 MORE
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 […]. MORE
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 MORE
The Life Sciences sector is facing a period of profound change and disruption. MORE
The online credentials for 68% of pharmaceutical executives analyzed for a study have been compromised recently. The study, conducted by cybersecurity firm Blackcloak, found that the email accounts of over two-thirds of pharmaceutical executives had been compromised within the last five to ten years. C-suite executives have been a frequent target for hackers and scammers, but Pierson identified some vulnerabilities specific to the pharmaceutical industry. “In MORE
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). MORE
56 
While pharmaceutical companies worldwide are working on the research of a vaccine for the ongoing COVID19 pandemic, threat actors are conducting cyber espionage campaigns in the attempt of stealing information on the work. MORE
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. MORE
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. MORE
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. MORE
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 MORE
147 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. MORE
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. MORE
The Department of Human Services fields large volumes of requests for Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) data from state and federal policing agencies each year. MORE
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. MORE
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 MORE
Content Services Healthcare & Life Sciences manufacturing Documentum Documentum for Life Sciences pharmaceutical Documentum for Quality and Manufacturing research and development MORE
Trojan Chrome browser extensions spied on users and maintained a foothold on the networks of financial services, oil and gas, media and entertainment, healthcare and pharmaceuticals and government organizations. Malware Privacy Vulnerabilities Web Security Awake Security chrome web store CommuniGal Communication domain Domain Registrar GalComm Google Chrome browser malware web browser MORE
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? MORE
125 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. MORE
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 MORE
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 MORE
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 Pharmaceutical MORE
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 MORE
Healthcare Related Topics Data Breach Today
JULY 8, 2019
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
IT Governance
MAY 16, 2019
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Hunton Privacy
MAY 19, 2016
Recently, Aegerion Pharmaceuticals announced that it will enter into several settlements and plead guilty to two misdemeanors in connection with alleged violations of HIPAA, drug marketing regulations and securities laws. The criminal charges stem from the company’s marketing of a cholesterol drug called Juxtapid.
OpenText Information Management
AUGUST 28, 2020
Content Services Healthcare & Life Sciences manufacturing Documentum Documentum for Life Sciences pharmaceutical Documentum for Quality and Manufacturing research and development
OpenText Information Management
JANUARY 23, 2020
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.
OpenText Information Management
JUNE 4, 2020
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.
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OpenText Information Management
JUNE 17, 2020
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
OpenText Information Management
JANUARY 28, 2020
You can’t deliver tomorrow’s innovation if you’re still using yesterday’s business models. For Healthcare 4.0, that means designing services and solutions around patients and empowering them to take more control, becoming partners in their own healthcare.
Data Breach Today
MAY 5, 2020
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.
OpenText Information Management
AUGUST 26, 2019
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
OpenText Information Management
NOVEMBER 12, 2019
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.
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OpenText Information Management
DECEMBER 18, 2019
If you work in the Life Sciences industry, your head will be nodding in confirmation while reading Forrester’s The Five Big Trends report, especially the part that states employee productivity has emerged as the second biggest driver for ECM investment in 2019.
OpenText Information Management
NOVEMBER 28, 2019
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.
Data Breach Today
AUGUST 3, 2020
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
Data Breach Today
MAY 29, 2020
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
DXC
APRIL 30, 2019
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 […].
OpenText Information Management
FEBRUARY 26, 2018
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).
erwin
FEBRUARY 7, 2019
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.
OpenText Information Management
MARCH 13, 2018
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.
IT Governance
SEPTEMBER 4, 2018
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 Pharmaceutical
Data Breach Today
DECEMBER 13, 2018
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?
OpenText Information Management
JULY 3, 2018
When major acquisitions happen, market analysts, competitors, customers, and employees alike are watching closely to determine what’s next.
The Guardian Data Protection
JULY 21, 2018
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.
erwin
MARCH 28, 2019
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.
Data Breach Today
MAY 4, 2018
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.
Perficient Data & Analytics
JUNE 21, 2018
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.
Perficient Data & Analytics
JUNE 1, 2018
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
Perficient Data & Analytics
JUNE 7, 2018
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.
Perficient Data & Analytics
JULY 19, 2018
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!
Perficient Data & Analytics
JUNE 28, 2018
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
Perficient Data & Analytics
JULY 5, 2018
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.
Box
JANUARY 18, 2018
Organizations in the life sciences, including pharmaceuticals, biotech and medical device companies, are rapidly transforming.
Threatpost
JUNE 18, 2020
Trojan Chrome browser extensions spied on users and maintained a foothold on the networks of financial services, oil and gas, media and entertainment, healthcare and pharmaceuticals and government organizations. Malware Privacy Vulnerabilities Web Security Awake Security chrome web store CommuniGal Communication domain Domain Registrar GalComm Google Chrome browser malware web browser
DXC
FEBRUARY 19, 2020
by Mark Wren It wasn’t long ago that healthcare and pharmaceuticals were treated as separate industries and the crossover – when it happened – was just in terms of how clinicians used drugs and devices.
Data Breach Today
MARCH 2, 2018
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
OpenText Information Management
SEPTEMBER 1, 2020
The Life Sciences sector is facing a period of profound change and disruption.
DXC
MARCH 14, 2019
by Satish Nair and Manjunath Shanabag Pharmaceutical companies struggle with a complex and, often, poorly managed partner, customer and distribution network. It’s not surprising, given the makeup of most large pharma companies. Large, often disconnected product portfolios are built through discovery — both internally and externally with academia and biotech partners — and global clinical […]. Analytics Business Processes Life Sciences
Security Affairs
SEPTEMBER 18, 2020
While pharmaceutical companies worldwide are working on the research of a vaccine for the ongoing COVID19 pandemic, threat actors are conducting cyber espionage campaigns in the attempt of stealing information on the work.
Adam Levin
MAY 7, 2020
The online credentials for 68% of pharmaceutical executives analyzed for a study have been compromised recently. The study, conducted by cybersecurity firm Blackcloak, found that the email accounts of over two-thirds of pharmaceutical executives had been compromised within the last five to ten years. C-suite executives have been a frequent target for hackers and scammers, but Pierson identified some vulnerabilities specific to the pharmaceutical industry. “In
The Guardian Data Protection
JANUARY 26, 2020
The Department of Human Services fields large volumes of requests for Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) data from state and federal policing agencies each year.
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