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Pharmaceutical, biotech and medical devices firms, among others, must comply with a plethora of regulations. This requires every company to perform gap analysis to determine what is required and then update their systems, processes, workflows and data management strategy accordingly to ensure compliance.
As a Contract Research and Manufacturing organization with over 330 clients around the globe, regulatory compliance is non-negotiable for Syngene International. Its integrated scientific solutions necessitate careful documenting of trials, test results, product formulae, manufacturing processes, and more.
These initiatives can include digital transformation, cloud migration, portfolio and infrastructure rationalization, regulatory compliance, mergers and acquisitions, and innovation management. Regulatory Compliance Through Enterprise Architecture & Business Process Modeling Software.
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. A recent poll of some 300 senior executives from U.S.-based LW: How does AI factor in?
Enhance Trade Compliance: Scan through free trade agreements to identify trade regulations and clauses that may impact you to avoid penalties. Manufacturing: Optimize production schedules, manage inventories, and ensure that facilities are running efficiently.
Today, enterprises are trying to grow and innovate – while cutting costs and managing compliance – in the midst of a global pandemic. Compliance and Legislation : How do we manage uncertainty around legislative change (e.g., Enterprise architecture is central to managing change and addressing key issues facing organizations.
By adopting FAIR Data Principles, life sciences firms (pharmaceuticals, biotech, medical device manufacturers) can accelerate data sharing, improve data literacy (understanding of data) and increase overall transparency and auditability when working with data. Reusable – metadata should include rich business and technical context.
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. Confront new compliance challenges as a result of the changes you had to institute? Have you had to revisit and reset priorities?
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.
In the world of pharmaceuticals, something interesting keeps happening — companies acquire, merge, or divest from other companies. It’s like a puzzle they’re trying to solve getting the right products, improving their research options or manufacturing capacity, and making sure everyone knows they’re here to stay.
Manufacturing execution systems (MES) have grown in popularity across the manufacturing industry. If your manufacturing processes have become more intricate and challenging to manage manually, an MES can help streamline manufacturing operations management, increase efficiency and reduce errors.
This language requires companies to review their data processing policies very carefully to ensure compliance. For example, consider the hypothetical case of Class Action Plaintiffs vs. ABC Pharmaceutical Company. GDPR, OJ L119 at 35 (emphasis added). discovery and international privacy rules.
Counting Down to the EU NIS2 Directive madhav Thu, 05/23/2024 - 05:16 Our recently released 2024 Data Threat Report showed a direct correlation between compliance and cyber security outcomes. 84% of organizations that failed a compliance audit reported having a data breach in their history.
ISO/IEC 27006-1:2024 Information security, cybersecurity and privacy protection – Requirements for bodies providing audit and certification of information security management systems complements ISO/IEC 17021-1 and requires ISO 27001-certified organisations to show evidence that they are maintaining their compliance with the Standard.
Healthcare organizations need a strong data governance framework to help ensure compliance with regulations like the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in the US and the General Data Protection Regulation (GDPR) in the EU. Issues with compliance and audit conduct also arise due to these scattered data sources.
Next to these two entities, Annex II contains the ones listed below: postal and courier services; waste management; manufacturers and distributors of certain chemicals; food producers and distributors; manufacturers of certain critical products, such as some medical devices, transport equipment, motor vehicles, trailers, electrical equipment, etc.;
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.
As we see banks increasingly prioritize resiliency, performance, security and compliance, there are many external factors that can impact the financial services industry that they must be ready for. As semiconductor manufacturers look to innovate quickly, electronic design automation (EDA) tools can be a key asset.
Management bodies of essential and important entities will have to approve these cybersecurity risk management measures, supervise their implementation and be liable for non-compliance by the entity. In contrast to the previous regime, both essential and important entities are subject to the same set of obligations.
For example, the marketing department in a pharmaceutical company should never be trying to access the drug research data, and the warehouse employees of an e-commerce company should not be trying to access employee personal information from the file server’s human resources (HR) folders. Significant Data Changes.
A Self-Learning Data Platform breaks down silos among medical affairs, marketing, business intelligence and manufacturing, and helps develop a common understanding of customer data and market insight across all departments. Loss of Exclusivity Phase: Value Extraction via Data.
For these reasons, many Chief Data Officers , Chief Information Officers, and heads of Enterprise Architecture and MDM have replaced their legacy master data management systems with Reltio Connected Customer 360 , including many of the top 10 pharmaceuticalmanufacturers, financial services and insurance companies, and global technology companies.
Sharing My Experience For example, the Pharmaceuticalmanufacturing company I use to work for had alliances with several community colleges to provide these hands-on experience to these students. This could spell disaster for any pharmaceutical company. Sourced and bred by an in-house program.
Automotive With applications of AI, automotive manufacturers are able to more effectively predict and adjust production to respond to changes in supply and demand. Intelligent automation also helps insurance companies adhere to compliance regulations more easily by ensuring that requirements are met.
The CCPA includes several exemptions that may permit health and life sciences companies to limit their compliance obligations or exempt their activities entirely. Some, but not all, health and life science entities are exempt from the CCPA. Determine what data is covered by the CCPA. HIPAA covered entities and business associates.
The CCPA includes several exemptions that may permit health and life sciences companies to limit their compliance obligations or exempt their activities entirely. Some, but not all, health and life science entities are exempt from the CCPA. Determine what data is covered by the CCPA. HIPAA covered entities and business associates.
The CCPA includes several exemptions that may permit health and life sciences companies to limit their compliance obligations or exempt their activities entirely. Some, but not all, health and life science entities are exempt from the CCPA. Determine what data is covered by the CCPA. HIPAA covered entities and business associates.
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.
For the past three years, OpenText™ Enterprise World in July has been the destination of choice for business leaders and partners who have invested in Enterprise Information Management with OpenText.
The draft provides some comfort by excluding manufacturing and operations information and organizations’ internal management information from the scope of “important data.” The draft Data Security Measures do not define “sensitive personal data.”
IT, Legal, Records, Privacy, Security, Compliance Finance, Audit and other areas can manage their information alone. Specialists in finance, operations, compliance, legal matters, and others are highly trained in their disciplines. Conversely, technology specialists rarely train on the intricacies of law, compliance and privacy.
When major acquisitions happen, market analysts, competitors, customers, and employees alike are watching closely to determine what’s next. In fact, employees like me were not terribly nervous when OpenText™ – a long-standing leader in enterprise content management – acquired Dell EMC’s Enterprise Content Division in January 2017.
The alarm manufacturers provide an app – which they claimed was “unhackable” – that allows users to lock their cars using their smartphone. Some commenters, like Senior Consultancy Manager Nicky Whiting, found that organisations had become complacent about their GDPR compliance requirements.
Avoiding regulatory uncertainty: If AI rules are applied inconsistently across different sectors, companies may struggle with compliance. AI applications such as in drug development and manufacturing will need to align with these internationally recognized requirements. Clear, harmonized guidance will be essential.
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