Change management is widely used in the life sciences, medical technology, pharmaceutical manufacturing and biotechnology and means that proposals for changes must be evaluated according to a controlled process in order to be realized in a quality-assured manner. The term is used both for operational and product changes.
Common challenges in change management
It is difficult to get an overall overview of all the proposed amendments without the support of a well-functioning management system. It is also difficult to obtain evidence for which changes should be prioritized and why. Proposals are often left lying around and good ideas are not implemented. And once something is done, it is difficult to know who is responsible for handling it at different stages and what has been done by whom.
The selection and implementation of CANEA ONE went smoothly and today it is difficult to see how the business could manage a single day without the system.
Mattias Andrup, Medical Affairs Director, ABIGO Medical AB
This is how we can help your business
Our controlled change process ensures that all requests are evaluated. The results are visualized in selection lists in order to be able to prioritize what is to be carried out and in what order. If, for example, 200 proposals for changes have been received and ten of them in an analysis have been shown to generate great benefit in combination with relatively low cost, then these should end up at the top of the priority list.
When the change is implemented, it is controlled by system functionality that ensure that the various steps are carried out correctly and on time. If this is not the case, the user is reminded both via the system and via email notifications. Those responsible can follow in real time where the change is in the process and who is currently responsible.
After a completed year, or any other time period of your choice, it is easy to produce graphical analyzes that show, for example, the number of changes made. They can also be broken down by office, department, process or cost center. Related, but optional, information such as whether the budget and time frames have been met and whether the client is satisfied can also be obtained.
Realizes strategies and creates understanding and commitment among employees through the connections to the daily operations.
Increases the ability to deliver lasting results and maximizes the benefit of investments made.
Visualizes processes and makes the business process descriptions available and up-to-date.
Free up time for the actual business through a better overview and smoother handling of cases.
Ensures that the right information is in the right place and can be handled by the right person.
The best of CANEA ONE
CANEA ONE is used to manage everything from deviations, CAPAs and complaints to audits, changes, supplier evaluations and risks. Customers can easily make adjustments, with sometimes necessary re-validations, directly in the system and without having to consult experts. That simplicity in managing and using the system guarantees a vibrant and thriving eQMS that is appreciated by employees.
Each change proposal is systematically evaluated and those that are implemented are carried out according to the same efficient process where, for example, both analysis, decision, implementation and evaluation can be signed electronically by the person responsible. The process becomes completely traceable. CANEA ONE is simply a user-friendly and stable system that effectively helps you implement and evaluate your quality work.
We know how to handle changes
A guided and controlled change process is necessary when laws or regulatory requirements change. Especially for those who operate in highly regulated industries. Our unique combination of proven IT solutions, experienced management consultants and valued training means that we have what it takes to help you start or manage the change work in the best way.
Some of our customers
Since the start, we have helped hundreds of organizations become both more efficient and more profitable. Here are some examples of customers using CANEA ONE.
We've been helping businesses improve for more than 30 years. Contact our sales representatives for pricing or to get more material on CANEA's methodology for creating live and effective management systems that meet all the requirements of various standards.