CANEA ONE is a validatable eQMS system with customized features for Life Science companies
Verified standard system
We make sure that every release of CANEA ONE can be validated under the requirements of FDA Part 11, GxP, 13485 and Eudralex 4.
Data integrity and patient safety
Important, tested and validated functions related to electronic signatures, read receipts, logging and traceability.
Ready-to-use, proven functions include CAPA support, SOP management, training, risk analysis and decision support.
Makes things easy
We offer a solution that is quickly implemented, flexible, easy-to-use and maintain.
The life science industry consists of biotechnology, pharmaceutical and medical technology companies that develop medical innovations for the improvement of human health. By tradition, Sweden has a strong, innovative life science industry that enjoys excellent growth. Today, Sweden is in the top four European life science countries and is counted as one of the world’s leading countries in the field.
Developing medical innovations that are efficacious and safe for the patient is advanced, time-consuming, costly and exhaustive work. The process often takes many years and is very demanding as, in addition to working, the product has to be safe and capable of large-scale production. The industry and its products are subject to strict regulation based on requirements, standards and decisions by authorities that grant approval for new products on the market.
Creating efficient, user-friendly working methods while meeting regulatory and customer requirements is a major challenge. The difficulty of creating a management system in which it is easy to find, manage and maintain documents, procedures, cases and processes, and creating working methods with good applicability are common problems. This often leads to unnecessary administration, reduced transparency and overview, increased risk and difficulties in meeting requirements.
The CANEA solution
To make things easier for Life Science organizations from a management system perspective, CANEA has developed CANEA ONE – a complete, tried and tested IT solution validatable from strategy to implementation. Based on 20 years of management system experience, designed for ease of implementation, use and maintenance, the system comes with ready-to-use functions such as electronic signing, traceability, SOP management, CAPA and risk analyses.
CANEA works with a number of established companies in the medical, biotechnology and pharmaceutical industries and supports newly established companies in their efforts to comply with regulatory standards. So far, we have successfully delivered more than 250 implementation projects to customers in the regulatory landscapes of the EU and USA, and we work with the leading companies in the industry.
Implementation and validation
All versions of CANEA ONE released from our R&D department are verified against general requirements set by e.g. the FDA and Part 11.
Validating a system such as CANEA ONE requires input from both the standard product and the project. Just because a standard product is “validated”, it does not automatically mean we have a validated system.
The documents that must be drawn up to meet the requirements of a validated system in the Life Science industry are as follows:
- URS – User Requirement Specification – Designed by the customer.
- RM – Risk Management Analysis – Designed by the customer. Based on the URS. A risk analysis highlighting the greatest risks in the system based on the way the customer uses it.
- FS – Function specification – Designed by CANEA. A description of the way CANEA ONE complies with the requirements of URS from a functionality perspective.
- Configuration specification – Designed by CANEA based on how the software configuration is applied from the customer’s URS. AKA Design Specification. These are the specifications used to build the customer’s unique documentation systems
- Design review – the meeting between the customer and CANEA where a crosscheck is made between the URS and the Functions specification / Design specification
- Validation plan. Describes how the customer intends to validate the system
- Testing (protocols/plans, outcomes/reports). Testing that includes IQ, OQ and PQ. These are different qualifications.
- Validation Report. The final report “proving” that the system has been validated and meets the requirements imposed on the system.
We use CANEA ONE
Verifiable system meets high regulatory requirements
Medical device company Nidacon needed a verifiable system for document management. CANEA ONE was one of few systems that lived up to their stringent requirements.
ABIGO expands with a complete CANEA ONE solution
Pharmaceutical company ABIGO needed to improve its document management with help from a complete, user-friendly IT support system. The preferred solution was CANEA ONE.
Safely handle all instructions, procedures and other governing documents. Easily upload and edit documents that support authorization control, referral flows, templates, and versioning. Education and training through customized training steps and built-in proficiency assurance tests. Tests to ensure “read and understood” with read receipts, “received and read” and electronic signatures. Automated physical distribution of documents to notice boards etc.
Traceability and logging
All events and actions are traceable in the system and logged with a breakdown including the date, a time stamp and performer. This provides a good view of historical actions. A history log is kept for each document, project, process, or case to facilitate follow-up of any changes made, if desired, right down to field level. Support for process control and process monitoring.
Renders all types of risks in the operation associated with e.g. products, processes or projects transparent and easy to manage. Digitize risk information management throughout the life cycle. Monitor risks and link actions and documentation to them. Easily create custom forms to manage all types of risk information based on your preferences. Support for escalation, alarms and reminders.
Decision support through visualization and supervision of aggregated data in table and chart formats. Easily extract statistics and aggregated information from the system. Create analyses with any content and print reports for presentation in e.g. PDF or PowerPoint. Provides overviews from the general down to the detailed level.
CAPA & Change Control
Use built-in flows for e.g. corrective actions and changes, to increase efficiency, improve process compliance, and enhance quality assurance in management. Use functions for follow-up and statistics to systematically analyze and eliminate deviations such as product defects. The ability to constantly solve the root causes of problems and prevent their occurrence to assure the quality and safety of your processes and products. Decision support through the visualization, monitoring, reporting and analysis of aggregate data.
Create the conditions for successful projects, delivered on time and on budget. Support for project models and working methods means the project team has tools for such things as time planning, risk management, document management, budgeting, status reporting and resource planning. The ability to look over and prioritize among projects in the project portfolio with full insight into the status of each project in progress. Financial control and budget follow-up and a built-in communication flow in the project tool that brings all internal and external communications together in one place.
CANEA’s expertise and ability to provide guidance during the preparation of the structure of the system is something we have not experienced with previous suppliers. I highly recommend CANEA ONE to other organisations within Life Science in need of e-signatures, read receipts and traceability. The system is flexible when necessary and robust when needed.
Maud Tallroth, Nordic Quality Manager, Air Liquide
Interested to know more?
Click here for contact.