PDM for small business

We help improve the productivity of your employees by creating a system
to promote the sharing and use of information in your company.

The larger the organization, the more complex the flow of information and the more difficult it is to share information at an accelerated rate. Can you say that the employees around you, and the superiors and subordinates who usually talk with each other, can share information enough? In addition, even if companies and organizations are able to manage information in an integrated manner, there will be few companies that can be said to be able to fully utilize information such as reference, reuse, and updating.

There may be various reasons for this, such as poor operability, poor accessibility, slow speed, and inability to search, but we support the promotion of information sharing and utilization inside and outside the company.

PDM Solutions for Small Business Locations

PDM and document management are areas in which similar functions are required, ranging from start-up R & D-oriented venture companies to global pharmaceutical companies.

HOYA Group has been increasing the added value of its products to medical devices such as medical endoscopes, intraocular lenses and artificial bones based on the technologies of glass and optical devices, which are regular occupations. We provide our customers outside the Group with the same mechanisms and computer validation know-how as the PDM management systems used within the HOYA Group including our own.

There are common hurdles for companies that handle medical devices and pharmaceuticals. It is a response to investigations and inspections by audit authorities represented by FDA.

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.

Support for information sharing site construction

Workflow function

In many cases, it is necessary to manage procedure manuals and drawings that require strict change management and version management. This solution is equipped with a workflow function as standard, and can support most workflows. We propose version management by combining third-party solutions for workflow implementation that requires more complicated, change of approver depending on amount and content, conditional branching, etc.

Workflow function
1

Change application

  • Create a "revision plan" by referring to the latest document version
2

Revision of documents

  • Check In
  • Check Out
  • Revising documents in the system
3

Approval of documents

  • Electronic signature
  • Issuing additional flows for re-education tasks, etc.
4

Publication of documents

  • In case of update, the old version is automatically moved to the old storage
  • Publishing in PDF, etc.

Many companies use Outlook or Exchange server as their internal email, but the benefits of using the same Microsoft tools are great, and as a workflow function, you can edit and confirm these files online in the cloud without, for example, sending linked emails to approvers when a document has been revised, or downloading and saving Excel, Word, PowerPoint, and other files locally for security reasons. Since it is the same Microsoft tool as Word and Excel, the operability is unified, so you can use it from the beginning without any discomfort so that almost no training is required. It can also be fully integrated into the Outlook screen.

Task management function

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.

Task management function

Strict authority and version control

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.

Authority by process

  • Authority to make design changes and new versions
  • Authority to procure raw materials, warehousing and withdraw
  • Operation authority for each manufacturing process

Authority by responsible role

  • Designer
  • Process staff
  • Authorizer
  • Quality assurance department

etc.

Strict authority and version control

Trace function

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.

  • Occurrence of product defects and DHR
  • History of past design (change) records
  • DMR change history
  • Document creation/modification date and time
  • Document creator / modifier

etc.

Trace function

Cloud application linkage

We offer solutions that combine Microsoft's cloud capabilities with a wealth of applications and features, enabling us to expand as needed.
For example:

Outolook linkage function

  • User, customer, or other email address, address, or other attributes
  • Task, calendar linkage
  • E-mail reminders such as late tasks, approvals, and process delays

CRM linkage

  • Physician master management, hospital and clinic management, opportunity and lead management
  • Pre-sales demo, equipment rental management, field service

ERP linkage

  • Inventory management, financial accounting, management accounting

etc.

Cloud application linkage

Search function

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.

  • Create keywords for images automatically
  • Convert audio data to text for searching
  • Extract useful information from a video
  • Categorize data

etc.

Search function