Effortlessly Maintain Compliance for Quality Documents and Processes
A QMS with poor document and process management practices means wasting your money
- I am unable to manage the effort related to audit preparation
- My quality information is stored in disconnected silos with different interfaces
- I am unable to efficiently manage the users in my quality processes
- I don’t know how to share information with 3rd parties safely and correctly
- I do not have full control of my quality information
- KPI management is not available in our current system but is required
A solution to manage controlled documents and quality processes for life sciences
Poor document management systems and complicated practices for process management are wasting your time and money.
EXTEDO's Quality Management Hub powered by CARA offers a platform for managing quality documentation in a controlled and automated way, allowing you to focus on creating your documents and refining their content rather than managing them.
Request your personal EXTEDO Software Demo now!
Assign automatic quality control workflows
The Quality Management Hub powered by CARA provides everything you expect from a Quality Management Solution and more. Gain the power to assign automatic quality control workflows while using risk assessment tools to identify and counter threats before they happen. A dashboard functionality keeps you informed about the current status. The solution further includes all standard document creation, review, approval, sign-off, and publishing features, as well as controlled printing for your team to make your quality control processes efficient, accurate and effective.
Advanced quality automation
EXTEDO’s solution enables you to incorporate quality into your natural workflow. Easily create internal or external Quality Events for regular quality assurance checks, audits, complaint resolution, and more.
You can even create and manage CAPA items for Quality Events, including sharing with external auditors to allow them to update CAPA info directly.
AI-powered insights for quality events and complaints
With the integrated AI functionality, EXTEDOpulse AIxpt, quality events and complaints captured within our QMS can be analyzed and interpreted using an intuitive AI chat interface. Instead of manually searching, extracting, and compiling data, users can ask natural language questions and instantly receive structured, reliable answers. AIxpt enables quality teams to interact directly with their quality data, helping them to identify whether complaints or quality events exist for a specific product or group of products, retrieve impacted batch numbers and affected products, compare complaints and events in structured tables, detect trends that support root cause analysis and decision-making, among other use cases. All insights are derived from validated data already managed within the Quality Management Hub, ensuring consistency, traceability, and compliance.
Assign automatic quality control workflows
The Quality Management Hub powered by CARA provides everything you expect from a Quality Management Solution and more. Gain the power to assign automatic quality control workflows while using risk assessment tools to identify and counter threats before they happen. A dashboard functionality keeps you informed about the current status. The solution further includes all standard document creation, review, approval, sign-off, and publishing features, as well as controlled printing for your team to make your quality control processes efficient, accurate and effective.
Maintain and monitor your GxP relevant equipment throughout its lifecycle in a transparent way
Integrated equipment management functionalities allow you to track the different lifecycle states of your equipment - from initial qualification to maintenance and final inactivation. The status of every asset is documented in one system, facilitating correct maintenance intervals and effectively reducing costs. Collect, access, and manage detailed information regarding qualification and maintenance activities with the logbook data item, ensuring the efficient and economical operation of your material and thus your entire work procedures.
A solution for every quality challenge
The Quality Management Hub powered by CARA gives you the tools you need to perform any quality control task from a single location. Well-structured data-capturing masks allow you an easy way to track all information and guide you through the necessary steps of analyzing a Quality event. Simultaneously, helpful Corrective Action and Preventative Action (CAPA) items make issue resolution a swift and seamless experience. Send change requests that are reflected throughout your organization for quick results, while detailed effectiveness evaluations indicate where you can optimize your processes.
Services
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Business Process and Regulatory Consulting Services
Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.
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Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics. Designed to educate you on how to utilize your EXTEDO solution, our training sessions are conducted either in-house or onsite.
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Technical Consulting
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.
