Streamline your management of controlled documents

Track and handle quality processes in a controlled and transparent manner

Enhance efficiency with automated workflows and alerts

A QMS with poor document and process management practices means wasting your money

Managing large numbers of controlled documents and processes within a QMS is complex, requiring significant time and effort.

  • 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
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Managing controlled documents and quality processes should be effortless.

 Empower quality with automation

Use workflows for review, approval, periodic review, and redundancy activities.

 Gain quality insights & direction 

Provide your team with dashboards for a transparent overview and to consistently improve quality. 

 Use automation for learning management 

Allow the learning management to help you perform trainings in a structured way.

 Go beyond quality document management 

Create and manage quality events, audits, CAPAs, and supplier qualification.

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EXTEDO has been working in highly regulated environments for over 25 years. We understand the detail of controlled document management and processes and help you stay compliant.
"EXTEDO is a great example of a company that really understands the requirements of the market."
Director Business Development, Technical Operations and International Business at Genericon

Your plan to effortless compliance

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Book a meeting 

We’ll discuss your challenges and goals with managing your quality processes and controlled documents.

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Create a plan

We will outline an approach to simplify the management of your processes and controlled documents.

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Take control of your documents

With automated processes, you can effortlessly manage quality documentation and stop worrying about audits.

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.

eDOCSmanager Quality 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.

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Request your personal EXTEDO Software Demo now!

Assign automatic quality control workflows

EXTEDO’s QMS tool 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.

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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. 

 
 
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Capture and provide document training from a single, intuitive interface

Automatically manage workflows for the generation, approval, and periodic review of your controlled documents. EXTEDO’s solution enables you to capture and provide document training from a single, intuitive interface. When training efforts are performed, the module records the accomplishment and marks it as completion with certificate attachments and training reports, helping you gain control over the professional development of your team. 

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A solution for every quality challenge

EXTEDO’s solution 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.

 
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Book a meeting

Services

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 through the entire product lifcecycle. 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.

Services

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. 

Services

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.

Services

Validation Services

Successfully passing an audit from the regulatory agencies requires validated computerized systems. Our team of validation experts has an in-depth knowledge of life sciences business processes, ensuring a tried-and-tested method of system validation. By utilizing the risk-based approach to compliant GxP computerized systems defined within the GAMP 5 standard, we aim to reduce the time, effort, and cost associated with getting your systems up and running.

Resources

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EXTEDO eDOCSmanager Product Information

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EXTEDO eDOCSmanager Quality Module Product Information