How a global research and manufacturing company achieves regulatory compliance

OpenText Information Management

As a Contract Research and Manufacturing organization with over 330 clients around the globe, regulatory compliance is non-negotiable for Syngene International.

Introducing OpenText Content Cloud for Life Sciences

OpenText Information Management

OpenText™ is thrilled to announce the launch of OpenText Content Cloud™ for Life Sciences, an innovative new offering that brings the proven productivity and governance capabilities of OpenText™ Documentum™ for Life Sciences to a cloud environment.

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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.

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

Regulatory Information Management Systems: The What & the Why


Regulatory Information Management Systems/Software, or RIMS, are platforms that have emerged to assist pharmaceutical companies and medical device manufacturers in submitting products for regulatory review.

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. One such case occurred when Sinovel, a leading wind-turbine manufacturer, headhunted an employee of AMSC, an energy technology company that owned proprietary wind turbine technology. Cyber Resilience Healthcare Intellectual Property Life Sciences Pharmaceutical

Europe’s Largest Private Hospital Operator Fresenius Hit by Ransomware

Krebs on Security

Security researchers say the Snake ransomware is somewhat unique in that it seeks to identify IT processes tied to enterprise management tools and large-scale industrial control systems (ICS), such as production and manufacturing networks.

Learn. Transform. Advance.


To survive and eventually thrive in the face of radical disruption requires transformation that’s just as radical: Developing new business models, like breweries and distillers manufacturing hand sanitizer. Learn. Transform. Advance.

China-linked APT10 leverages ZeroLogon exploits in recent attacks

Security Affairs

Targeted sectors include: Automotive Clothing Conglomerates Electronics Engineering General Trading Company Government Industrial Products Managed Service Providers Manufacturing Pharmaceutical Professional Services.

New financially motivated attacks in Western Europe traced to Russian-speaking threat actors

Security Affairs

At least two companies operating in pharmaceutical and manufacturing sectors have been affected. Researchers at Group-IB observed new financially motivated attacks in Western Europe traced to Russian-speaking threat actors.

Hackers target German Task Force for COVID-19 PPE procurement

Security Affairs

“The remaining half belong to executives at third-party partners, including European and American companies associated with chemical manufacturing, aviation and transport, medical and pharmaceutical manufacturing, finance, oil and gas, and communications.”

China-linked APT41 group exploits Citrix, Cisco, Zoho flaws

Security Affairs

Victims operate in the Banking/Finance, Construction, Defense Industrial Base, Government, Healthcare, High Technology, Higher Education, Legal, Manufacturing, Media, Non-profit, Oil & Gas, Petrochemical, Pharmaceutical, Real Estate, Telecommunications, Transportation, Travel, and Utility. .

Enterprise Architecture: Secrets to Success


erwin has a proven track record supporting enterprise architecture initiatives in large, global enterprises in highly regulated environments, such as critical infrastructure, financial services, healthcare, manufacturing and pharmaceuticals.

Oracle InForm Study Building


Through client projects and having worked at pharma companies in previous roles, they know the many unique challenges and needs of pharmaceutical and medical device companies.

Q&A: How AI, digital transformation are shaking up revenue management in high tech, life sciences

The Last Watchdog

based life sciences and high-tech manufacturing companies sheds light on how digital transformation – and the rising role of third-party partners – have combined to create unprecedented operational challenges in the brave new world of digital commerce. Model N’s 2019 State of Revenue Report surveyed CEOs, CMOs and senior sales executives from leading pharmaceutical, medical devices, high-tech manufacturing and semiconductor companies.

Enterprise Architecture and Business Process Modeling Tools Have Evolved


The power to adapt the EA/BP platform leads global giants in critical infrastructure, financial services, healthcare, manufacturing and pharmaceuticals to deploy what is now erwin Evolve for both EA and BP use cases.

Connecting the Bots – Hancitor fuels Cuba Ransomware Operations

Security Affairs

As of April 28, the site mentioned nine companies primarily from aviation, financial, education and manufacturing industries. The Cuba Ransomware gang has partnered with the crooks behind the Hancitor malware in attacks aimed at corporate networks.

List of data breaches and cyber attacks in May 2021 – 116 million records breached

IT Governance

For the second month in a row, ransomware has dominated our list of data breaches and cyber attacks. Of the 128 publicly disclosed incidents that we discovered in May, more than 40% of them were ransomware attacks.

US DoJ indicts Chinese hackers over state-sponsored cyber espionage

Security Affairs

The list of victims includes at least the following organizations: seven companies involved in aviation, space and/or satellite technology; three companies involved in communications technology; three companies involved in manufacturing advanced electronic systems and/or laboratory analytical instruments; a company involved in maritime technology; a company involved in oil and gas drilling, production, and processing; and the NASA Goddard Space Center and Jet Propulsion Laboratory.

List of data breaches and cyber attacks in November 2020 – 586 million records breached

IT Governance

We recorded 103 cyber security incidents in November, which accounted for 586,771,602 leaked records. The majority of those came from a credential-stuffing attack targeting Spotify and a data leak at the messaging app GO SMS Pro, which you can learn more about below.

List of data breaches and cyber attacks in August 2020 – 36.6 million records breached

IT Governance

There were a massive 99 data breaches and cyber attacks in August, making it the third-biggest monthly total of the year by number of security incidents. But, by contrast, only 36,673,575 records were confirmed to have been leaked, which is the fewest we’ve recorded since May 2018.

ABBYY Achieves Double-Digit Annual Revenue Growth for Third Consecutive Year

Document Imaging Report

ABBYY FY19 revenue growth driven by RPA partnerships, expanded product portfolio, and strengthened global presence. MILPITAS, Calif.,

Episode 158: How NotPetya has Insurers grappling with Systemic Cyber Risk

The Security Ledger

And, for companies impacted, it was impressively damaging: halting production lines and operations at global corporations in shipping, pharmaceuticals and manufacturing. We talk to Bruce McDonnell of the East West Institute about how insurers are responding.

China-linked hackers target government agencies by exploiting flaws in Citrix, Pulse, and F5 systems, and MS Exchange

Security Affairs

CISA published an advisory on China-linked groups targeting government agencies by exploiting flaws in Microsoft Exchange, Citrix, Pulse, and F5 systems.

List of data breaches and cyber attacks in October 2020 – 18.4 million records breached

IT Governance

With 117 publicly reported security incidents, October 2020 is the leakiest month we’ve ever recorded. The good news is that those data breaches and cyber attacks accounted for just 18,407,479 breached records.

Interpol warns that crooks are increasingly targeting hospitals

Security Affairs

According to experts from Group-IB, Russian-speaking threat actors targeted at least two companies in Western Europe in the pharmaceutical and manufacturing industries.

Customer Experience Trends: How To Stand Out From the Crowd


Every organization — from mom and pop shops to pharmaceutical manufacturers — must adopt tools and techniques for providing the hyper-personalized experiences customers require at every touchpoint in their journey. .

European Commission proposes reinforcement of EU Cybersecurity rules

DLA Piper Privacy Matters

Authors: Raf Schoefs , Simon Verschaeve , Laetitia Mouton.

CVS Sued for Alleged Privacy Violations

Hunton Privacy

The letters encouraged the physicians to prescribe drugs made by pharmaceutical manufacturers, who paid CVS to send them. The Texas complaint alleged that CVS disclosed PHI to pharmaceutical manufacturers for the manufacturers’ marketing purposes.

US DoJ charged two Chinese hackers working with MSS

Security Affairs

The duo targeted organizations in multiple industries, including high tech manufacturing, medical device, civil, and industrial engineering, business, educational, gaming software, solar energy, pharmaceuticals and defense.

Preservica appoints new Advisory Council to help steer next stage of growth


He has extensive experience working with Federal and Local Government agencies, as well as companies in Energy, Financial Services and Manufacturing. He has worked closely with companies in both Pharmaceutical and Financial Services industries.

Supreme Court Strikes Down Vermont Prescriber Privacy Law

Hunton Privacy

Vermont’s law was intended to limit the process of “detailing” whereby pharmaceutical manufacturers use prescriber-identifiable information to “ascertain which doctors are likely to be interested in a particular drug and how best to present a particular sales message.” In other words, the “limited privacy” the statute affords prescribers requires them “to acquiesce in the State’s goal of burdening disfavored speech by disfavored speakers” such as pharmaceutical marketing companies.

The Applications of Blockchain in Data Management


It can represent a considerable challenge for businesses in the food and pharmaceutical sector, as billions are lost every year through theft, fraud, and counterfeiting. Blockchain is one of the most important new technologies that has impacted the business world in the last decade.

How To Solve The Cybersecurity Skills Shortage

Cyber Info Veritas

Sharing My Experience For example, the Pharmaceutical manufacturing company I use to work for had alliances with several community colleges to provide these hands-on experience to these students. Because my company was growing at a fast pace due to the demand on the products we were manufacturing, we were required to grow our in-house IT personnel and skills at the same pace, which was a challenge. This could spell disaster for any pharmaceutical company.

Security in a World of Physically Capable Computers

Schneier on Security

This fails in low-cost devices , whose manufacturers don't have security teams to write the patches: if you want to update your DVR or webcam for security reasons, you have to throw your old one away and buy a new one. The courts have traditionally not held software manufacturers liable for vulnerabilities. It's no secret that computers are insecure.

Think Outside of the Gartner Magic Quadrant for Master Data Management Solutions to Deliver Connected Customer Experiences


Customer experience. It’s one of the buzziest terms in business. And it should be. If you haven’t come to the conclusion that CX matters, volumes of research quantifies the value of providing an exceptional - or even decent - customer experience, and the perils of getting it wrong. .

Why You Should Teach Yourself Cybersecurity

Cyber Info Veritas

In highly regulated companies, such as Pharmaceuticals, their manufacturing processes are bound to procedures which are audited periodically. Successful people like to know and understand the intricacies of their subject of work. This way they gain control over the subject they are learning about, which would help them when making decisions. Every successful professional or business person have some things in common.

Why Data Now Makes Every Company a Tech Company


The company has more than 172,000 employees and sells its product across 70 countries for numerous markets ranging from cooking oil to baby food to cosmetics to pharmaceuticals. It no longer matters if your company is a food grower, a manufacturer, a trader, a retailer, or in the case of Sinar Mas, all of the above.

Understanding Blockchain and its Impact on Legal Technology, Part Two

eDiscovery Daily

Areas such as financial services, technology, manufacturing, pharmaceutical, and energy industries all needed systems with these two factors. Editor’s Note: Tom O’Connor is a nationally known consultant, speaker, and writer in the field of computerized litigation support systems. He has also been a great addition to our webinar program, participating with me on several recent webinars.