With its own active research and development programmes that require a great deal of flexibility, the company needed to find an equally versatile system without sacrificing the regulatory requirements. The preferred solution was CANEA ONE, and with its implementation all employees can now work in a common and structured way. Transparency at the company has also increased.
ABIGO Medical AB is a Swedish pharmaceutical company that owns, develops and manufactures pharmaceuticals and medical devices. The company is certified in accordance with the ISO standards 13485 and 14001 and complies with Good Manufacturing Practice (GMP), Good Medical Practice (GMP) and Good Distribution Practice (GDP). The operation requires a great deal of flexibility due to short decision processes and its own active research and development programmes which have excellent growth prospects. Consequently, a flexible and scalable system was needed that could satisfy regulatory requirements and standards, but also support change and growth initiatives. When the decision to invest in a document management system was made, CANEA ONE was already one option on the table because ABIGO’s Medical Affairs Director Mattias Andrup had previous experience of the system.
- “It was incredibly important that the system should satisfy the requirements and regulations that our operation is subject to, and that we should be able to validate the system. The selection process and implementation all went smoothly, and it is difficult to see now how the operation could manage without the system,” says Mattias.
As ABIGO’s operations expand, the need for system support has also increased and they now use modules for document management, projects and cases. Expanding with a modular system like CANEA ONE makes it easy for employees to get their bearings and work in the system. The benefits of this have been numerous. The system has reduced duplication of work between the business sites and has increased transparency at the company. Mattias also sees benefits in using a document management system for virtually all functions that currently deal with version-controlled documents and hard copy. This can be anything from marketing material to product descriptions or instructions on tablets for work on the production side. Traceability and history have also been simplified when working with authorities both in Sweden and abroad, which has strengthened the authorities’ trust in ABIGO as a market player.
- “CANEA ONE means that we can spend time on the right things, such as developing our business. I would absolutely recommend the system to other companies and have already done so to some of our distributors who were curious about it,” concludes Mattias.
ABIGO Medical AB is a Swedish pharmaceutical company that owns, develops, manufactures and markets pharmaceuticals and medical devices. The main medical device applications are advanced wound care, ear, nose and throat (ENT), and nutrition. The company was established in 1989 by the current owners, brothers Jan G Smith and Leif Smith, both of whom are still actively involved in ABIGO. The company has an international approach, with distribution of products in some 60 countries through its own sales organisations and partners.
It was incredibly important that the system should satisfy the requirements and regulations that our operation is subject to, and that we should be able to validate the system. The selection process and implementation all went smoothly, and it is difficult to see now how the operation could manage without the system.
Mattias Andrup, Medical Affairs Director
ABIGO Medical AB