Information Management within Life Sciences

Whether you’re a medical device, biotechnology, contract development & manufacturing organization (CDMO), contract manufacturing organization (CMO), cosmetics or pharmaceutical company, it is crucial to manage your content in a safe and compliant way and always have the right, up-to-date information available. We all know how crucial this is with for example the GxP conformity in place.

Smart robotic arm in a greenhouse taking care of plants

At AmeXio, we understand the challenges associated with the volumes of complex and sensitive information that life sciences organizations have to manage.

Think of:

  • Instructions to manufacture the medicine.
  • Drug Product related information including the Labeling documents
  • Training and courses that employees need to complete in order to do their job.
  • All information about medicines and how to use them.
  • Request for a new product, including the whole approval process. From testing to actually producing the medicine.
  • All highly sensitive information

Having a platform approach in which life sciences organizations connect each of their business applications to one Document Management System highly increases efficiency. With one single installation, all content is stored centrally, but at the same time, each department is using their own environment.

Challenges Life Sciences 

Moving to a digital way of working in an efficient and compliant way 

Speed and innovation

Bringing new products to market quickly is vital in life sciences to outpace competition, maximize patent windows, and address patient needs. However, lengthy research, complex development, diversity of regulations, stressfull market access, and finally just-in-time supply chain pose significant challenges

GxP validation

GxP validation is a rigorous, resource-intensive process that involves thorough documentation, testing, and continuous compliance to maintain product integrity and patient safety.

Protection of personal data

Protecting personal data is critical in life sciences to ensure patient privacy, comply with strict data protection regulations like GDPR and HIPAA, and maintain trust.

Massive amounts of data

Life Science organizations have to deal with thousands of documents every day. It is crucial to have clear, transparent and efficient processes in place to manage this content.

Information Complexity

Operating globally means dealing with diverse regulations and practices, which multiplies the number of documents for the same information. Your labeling department struggles to keep documents aligned with market-specific requirements.

AI (Artificial Intelligence)

How to deal with AI and decide what’s the best strategy for your organization. How can you benefit the most from it?

Our success story with L’Oréal

Our Solutions  

AmeXio offers a range of solutions that help you manage content in a professional, compliant and efficient manner.  

Structured Content Management

Structured Content is crucial for life sciences, streamlining the management of regulatory submissions, technical documentation, labeling, manuals, and patient info. They ensure consistency, compliance, and reusability, simplifying content creation and updates across channels.

Electronic Document Management

Electronic Document Management enables secure storage, easy retrieval, and efficient management of critical documents like regulatory files, SOPs, and quality records. It ensures compliance, enhances collaboration, and supports seamless audits.

Digital Archiving

It is essential to securely archive data such as training records, quality documents, research results, and production files for the long term. Digital archiving ensures compliance with strict regulations, facilitates audits, and guarantees that critical information remains accessible.

Business Process Management & Case Management

Business Process Management (BPM) and Case Management are essential in life sciences, not only strengthening your QMS but also streamlining a wide range of critical processes.

Connecting people & systems

We help define your strengths and identify gaps—AmeXio Consulting delivers audit reports and improvement plans to break silos. Next, we connect systems, design efficient workflows, and manage them to drive conformity and productivity.

Automation & AI

AI helps ensure your GxP content is consistent, such as aligning manufacturing instructions with eCTDs and complying with regulations. Generative AI can streamline regulatory processes by searching systems to provide accurate responses for regulatory departments and authorities. Of course, qualified employees have the final say in both cases.

Complementary Services

GxP Validation

GxP validation refers to the process of ensuring that systems, processes, and products comply with Good Practice (GxP) standards in regulated industries. At AmeXio we support life sciences companies with the steps they need to take to comply.

Contact us

AmeXio Cloud

AmeXio Cloud is a cloud-based solution offered by AmeXio Group, designed to provide flexible, scalable, and secure cloud infrastructure for businesses. It supports organizations in managing their content and data in the cloud, helping them streamline their operations, improve accessibility, and ensure compliance with industry standards, including GxP for regulated sectors like life sciences.

Read more about Cloud Solutions

Let’s talk! 

We have over 20 years of experience in content management within life sciences and are very well aware of related processes, challenges and systems. We are proud to speak our customers’ language and to have the experience and expertise to bring your content and information management to the next level.