Life Sciences Solutions

Life Sciences solutions that reinvent clinical, quality and regulatory processes transforming how Life Sciences organizations access, manage, analyze, share and gain insights from regulated content

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Life Sciences overview

Life Science companies, such as pharmaceutical, biotech and medical device and diagnostics manufacturers, operate in a highly regulated environment. Operations are both data and document-intensive. Business leaders are tasked with transforming their organizations into innovation centers, while maintaining tight regulatory compliance with governmental guidelines, such as the FDA's 21 CFR Part 11 and the EU's Annex 11. CIOs must enable other departments to share key information among team members and make the best decisions possible, while dealing with vast amounts of data and information often housed within legacy systems. Software for Life Sciences is designed to help tackle many of these challenges.

Segments served

Pharmaceutical

Innovative medicines, generic drugs and over-the-counter products

Biotech

Biological processes, organisms or systems to improve quality of life

Medical Device & Diagnostics

Instruments, apparatuses or machines for prevention, diagnosis or treatment

Life Sciences challenges

  • Increasing global regulations

    Life Sciences companies need to reduce the costs of regulatory operations and speed up health agency approvals to accelerate time to market. Functions across the value chain, such as Regulatory Affairs, Quality, R&D, Manufacturing, Marketing and Distribution are under strict directives to maintain documents and records under careful compliance to GxP, ISO, USP and other standards and regulations.

  • Profound disconnect across the value chain

    Research and Development, Production, Distribution and Marketing often create information silos, slowing the flow of information, such as Life Sciences content, among stakeholders and impeding time to market. This problem is compounded by the multitude of mergers and acquisitions occurring in the market.

  • Growing volume of data

    Life Sciences companies generate a vast amount of data from scientific research, clinical trials, patient profiling, compliance and regulatory requirements. As the volume and variety of data continue to grow, so do the challenges of managing and analyzing that data for maximum business advantage.

  • Rapidly changing Life Sciences technology

    Life Sciences companies are under pressure to balance innovation with cost-cutting measures across the enterprise, while ensuring the drugs brought to market are managed in a patient-centric way.

Life Sciences solutions

OpenText™ Life Sciences solutions are built on a portfolio of Enterprise Information Management (EIM) products and services designed to improve information governance, increase compliance, optimize business processes and implement analytics to drive innovation, insights and profitability.

Life Sciences solutions benefits

  • Streamline regulatory compliance with a single authoritative source of content

    Efficiently manage the creation, review and approval of regulatory submission documentation globally, while accelerating the submission process with uncompromised Life Sciences regulatory compliance and complete global control of content.

  • Unify processes that extend across domains, divisions and external partners

    Break down information silos with Life Sciences content management to unify processes and share relevant information with team members in a collaborative environment that spans the enterprise and includes alliance partners, contractors and consultants.

  • Leverage data for meaningful insight

    Augment traditional data management and data analytics with AI-powered Life Sciences analytics to gain actionable insights that translates into more efficient clinical trials, accelerated discovery and approval of new medicines, improved production and supply chain operations and more targeted sales and marketing.

  • Enhance engagement with customers, partners and employees

    Provide users with easy access to key applications and an interface tuned specifically for their role, enabling them with a unified solution layer to easily and intuitively accomplish their work.

Why OpenText for Life Sciences?

Unparalleled industry expertise

More than 100 Life Sciences specialists in all areas of the solution lifecycle including Engineering, Product Development, Value Consulting, Sales and Professional Services

Undisputed market leader in Enterprise Information Management

Leadership in Enterprise Content Management and Digital Asset Management offers Life Sciences organizations the confidence that their highly regulated information assets are managed in a defensible and compliant manner

Designed to drive autonomy and speed to value

Leverages the OpenText portfolio of products to provide comprehensive purpose-built solutions, that utilize industry guidance and best practices based on more than 25 years of experience working with Life Sciences companies of all sizes.

Pharmascience logo

OpenText is a real partner...the service they brought to the table was not only the knowledge of the application, but also all the project management. They knew how to deliver this project.

Denis Beauchemin, Head of IT, Pharmascience
Almac Clinical Services Limited logo

Locating documentation has become much quicker, saving up to 360 hours per week, which equates to £350K per year.

Janine Cheevers, Quality Systems Coordinator - Clinical Services
Dr. Reddy's Laboratories logo

A sound ECM strategy was needed to help us optimize our current storage to manage our growth. We needed a solution that could cope with our current and future needs seamlessly without compromising the productivity of our employees.

Mr. Krishna Sai, Senior Director of IT, Dr. Reddy's

Innovation in Life Sciences quality management

Life Sciences companies are accelerating their move to digital technologies, and quality assurance organizations have much to gain. This paper describes how automation can address the key factors driving change in quality management while reducing operational complexity and supporting innovation to create an Intelligent and Connected Enterprise.

Download the white paper

Achieve efficient MLR review and claims management

One of the biggest challenges for Life Sciences companies is efficiently using and managing digital media assets, while avoiding false claims and off-label promotion. Given the current global environment of digital transformation and the increasingly complex nature of regulations, these companies need to be more accountable and coordinated in their marketing approaches than ever before.

Download the white paper

AI-enhanced analytics can unlock the value in the vast amount of data generated by Life Sciences

Artificial Intelligence promises to transform how Life Sciences organizations will conduct all aspects of their business, from drug discovery and development to manufacturing and commercialization. This blog discusses the drivers for AI and use cases where AI-enhanced analytics will have the greatest impact within the next five years.

Download the white paper

Contact us to speak with a member of the Life Sciences team

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