APL has a social mission from the Swedish state to provide individualized medicines, so-called extempore medicines, and stock preparations. The mission also includes maintaining operations in crises. They are also an established contract manufacturer in the life science field, providing services in development, analysis, and manufacturing.
Manual handling
Until 2018, when APL acquired an eQMS, all document handling such as printing, copying, stamping, and signing was manual. However, the new system did not meet APL's needs and required development.
– It was inefficient and cumbersome, so we had to handle large parts of document management outside the system. It became more of a storage system than a document management system, recalls Inger Bergman, Head of Quality at APL, and continues:
– We evaluated five other system suppliers and then chose CANEA ONE, which in addition to meeting GMP requirements was a modern and user-friendly system.
Standardized work procedures
When APL decided to acquire CANEA ONE, the focus was on the management of quality documents in the form of SOPs (Standard Operation Procedures) and forms, but the system should also be able to handle documents that are not directly related to GMP.
– With the help of CANEA ONE, we can now create all types of documents and set up a process for each document type. We already have several types of documents in the system, in addition to SOPs and forms, such as policies & guidelines, SHM documents, risk assessments, and other quality documents.
CANEA Document and CANEA Workflow
CANEA ONE consists of five modules that can be used individually or together in various combinations. In addition to CANEA Document, APL also purchased CANEA Workflow to manage cases.
– The management of documents has become more efficient, and the entire flow of activities required for a document to take effect is now completely digital, which saves us a lot of time.
– Of course, introducing new systems and working methods always presents challenges, and not everything has turned out as we expected, but overall, I think we have succeeded well with the introduction of both CANEA Document and CANEA Workflow.
Results
APL now posts all types of documents and has a process for each document type, such as SOPs, forms, policies & guidelines, SHM documents, risk assessments, etcetera. They also post cases such as DEV, CR/CC, CAPA, and more.
"CANEA delivers what they promise. They have shown good cooperation and have listened to our needs."
Inger Bergman, Head of Quality Apotek Produktion & Laboratorier (APL)
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