HOYA Group has been manufacturing and selling medical devices such as endoscopes for some time, and I have come to realize that these audits require considerable time and effort. I think the hurdle for R & D-oriented startup companies is even higher.
Therefore, we recommend a PDM document management solution that focuses on budget and functions that can be introduced even in small businesses by members who have experience and knowledge of auditing.
Based on Microsoft's document management system SharePoint, we have added the document management functions required in the fields of medical devices, medical care, and medicine based on our knowledge inside and outside HOYA Group.
SharePoint solution itself is used by major pharmaceutical manufacturers in Japan, and it is a system and software with sufficient scalability.
In the design, development, and manufacturing processes over a long period of time, we ensure that records are kept from the viewpoint of document management, and control to prevent progress to the next process without implementation records.
For example, in cases where production records must be stored at specified checkpoints for a long period of time, such as in the cultivation process or the concentration of components derived from natural drugs, it is possible to require that the formal production records be stored.
By linking the system with ERP and MES functions, we provide a solution to ensure that work results (for example, input of raw materials) in response to work orders and to ensure that recorded documents are retained. In terms of manufacturing, we will proceed to the preservation of quality inspection records and the decision to use them.
As standard, SharePoint has a function to set possible operations for a document such as document creation, change / revision, and deletion. In addition to these authority management functions, it is possible to divide the possible operation authority for each process such as stricter design and manufacturing required for medical devices and pharmaceuticals.
Documents such as DHF and DHR are not deleted completely once they are created, and each time they are changed, the version number is updated and all previous versions are saved. In addition, the audit history is securely managed, making it difficult for the systems department to delete or change the audit history.
We offer solutions that combine Microsoft's cloud capabilities with a wealth of applications and features, enabling us to expand as needed.
For text information, such as Microsoft Word, PowerPoint, Excel, or PDF, SharePoint's standard search function can search the inside of a document, but you must enter keywords manually to make it easier for users to search for images, sounds, videos, and so on. HOYA Digital Solutions proposes to add various functions through AI and deep learning.