Life science industry
Navigating the regulatory landscape in the Life Science industry can be a complex task, especially when it comes to eQMS.
Introducing Centuri, a versatile and customizable solution designed to help you seamlessly meet regulatory requirements and streamline your digital processes. Whether you're in the pharmaceutical, biotechnology, or medical technology field, Centuri empowers you to create efficient workflows with minimal validation.
- Systematizes the quality work
- Ensures full traceability and data integrity
- Makes it easy to find the correct information
- Minimizes validation work
Challenges within Life Science
The pursuit of new breakthroughs in pharmaceutical and medical technology is a daring endeavor that demands unwavering commitment and substantial resources. It is not only essential for these innovations to be effective and beneficial to patients, but they must also ensure patient safety during large-scale production.
The life science industry operates within a framework of stringent regulations and controls to ensure that standards and requirements are upheld. Regulatory authorities impose strict demands for documentation and traceability throughout the different stages of a product's life cycle.
The abundance of documentation and the necessity for control frequently result in cumbersome manual administration and inadequate internal processes without proper system support. Consequently, this leads to challenges in locating information, inadequately documented internal procedures, and insecure storage of vital data.
Centuri as solution
Centuri is an innovative and customizable solution that adheres to the highest industry standards. By choosing Centuri, you can eliminate a significant portion of the validation process that is typically required with in-house developed systems.
Centuri not only enables you to meet all regulatory requirements, such as controlled access, life cycle management, and traceability, but also empowers you to effortlessly find, organize, and maintain documents. It provides a comprehensive management system that effectively addresses risks, deviations, and corrective actions while ensuring competence and authorizations. With Centuri, you can streamline your processes and enhance overall efficiency in the most seamless way possible.
With over two decades of expertise in life science management systems, Centuri has been meticulously crafted to effortlessly integrate into smaller businesses while still possessing the robust capabilities to support global scalability.
Complete solution for quality assurance
Systematize the quality work
Centuri helps you digitize information across the entire value chain, from product development to customer support.
With 2c8, you model and visualize the business processes and the document management gives you control over all governing and supporting documentation throughout the entire life cycle.
Centuri's case management empowers you to effortlessly establish workflows for various aspects, including product development, deviations, complaints, audits, and more.
With Centuri's Risk Management feature, you gain complete visibility into all the risks associated with your business. You have the opportunity to link preventative measures that will reduce these risks, while also allowing you to closely monitor any deviations that may occur.
By utilizing Centuri's competence and authorization management, you guarantee that individuals possess the necessary expertise to successfully execute their assigned responsibilities.
Data integrity and traceability
Ensure data integrity
Centuri empowers you to securely oversee and control your instructions, routines, product documentation, and checklists.
Centuri provides robust and validated assistance in managing the lifecycle and tracking changes, all the way down to individual form fields. Additionally, it offers a comprehensive reading log with receipts for a seamless reading experience. The electronic signature feature meets all the stringent requirements of FDA Part 11, including password management.
Data traffic in Centuri is secured through encryption, providing an additional option to encrypt the database itself. Our access controls ensure that only authorized individuals can access information, and ongoing penetration tests guarantee that data remains untainted by external forces.
Make it simple to find correct information
Filter out the noice
Empower your workforce to steer clear of needless work.
With our ready-made templates, writing accurately becomes a breeze. Our streamlined process flows guarantee quality and alignment through collaboration, referral, and approval. No need to worry about outdated information, as our versioning and lifecycle management take care of it all.
For those seeking information, our innovative tag system and advanced search algorithms efficiently sift through the clutter to deliver the most relevant content promptly. Get the precise information you need, precisely when you need it.
For those with a mobile workforce, we offer the flexibility to seamlessly display information directly in your production systems, thanks to our advanced REST-based APIs and Iframes. In addition, we provide quality-assured procedures for publishing on various platforms such as bulletin boards and binders.
Pre-validated standard system
Minimize validation work
Centuri is a state-of-the-art product, designed to simplify the validation process for you. Our commitment is to meticulously test and validate each release of Centuri, ensuring it complies with the rigorous requirements of FDA Part 11, MDR, ISO 13485, GMP, and more. Rest assured that any changes made to the product will not disrupt your existing configurations.
Throughout the implementation process, you will have full access to our comprehensive function specifications, allowing you to effortlessly align them with your specific requirements. To kickstart the project, we collaborate to create a dynamic design specification that serves as the foundation for seamless configuration, meticulous test case creation, and the final validation stages in accordance with IQ, OQ, PQ.
In addition, we provide validation protocols to assist you in streamlining the validation process and prioritizing essential modifications, allowing you to confidently validate your unique configurations.
Centuri as a management system
