Kabushiki Kaisha DNAFORM

Microsoft Office365 / Dynamics 365 enabled regulatory compliance in the medical field

Digitized quality-related documents and records with Office 365 / Dynamics 365

DNAFORM is a venture company of RIKEN, a national research and development corporation, and was established to make biotechnology, a result of joint research with RIKEN, widely available to the world. The company is rapidly developing its business centered on products and services based on its cutting-edge biotechnology, such as clone distribution, gene expression analysis, custom oligo synthesis, and nucleic acid detection.
The field of such leading-edge genetic technology is, in the same way as other fields, subject to requirements to have a system to ensure quality and to comply with audits based on safety standards such as ISO13485 for medical devices. Specifically, a system needs to be in place to manage a series of operations in compliance with regulations in the medical field, such as document management, record keeping, quality process management, and inventory tracing.
The company made a decision to adopt closely linked Microsoft Office 365 SharePoint and Dynamics 365 CRM to fulfill the requirements. In September 2017, the company selected HOYA Digital Solutions as implementation partner in order to incorporate the regulatory compliance know-how of HOYA, whose business is to manufacture and sell medical devices such as endoscopes, intraocular lenses, and artificial bones, and to employ its system implementation capabilities in this area.

Introduction purpose

  • Digitization of quality-related documents and records
  • Tracing of quality-related documents and records to physical inventory
  • Compliance with QMS regulations (ISO13485, 21 CFR 802) and Part11

Solution

  • Tightly integrated use of Microsoft Azure's SaaS products Office 365 and Dynamics 365
  • Prevention of document tampering and conflicts by using the online version of Office 365 as a base

Result of the change

  • Realized enhanced management over a series of document lifecycle and authority, including revision of quality documents, approval process and reference, change (version control), and storage.
  • Records from DHF (design history) to DMR (equipment register) and DHR (equipment history register) can now be traced and linked.
  • Support for Part 11-compliant electronic authentication is now in place.
  • Validations mandatory to medical systems can now be conducted more smoothly.
  • Realized inventory tracing from raw material purchase to product shipment
  • By linking DHR to trace inventory, it became possible to trace back to the design history of DMR, DHF, etc. of the shipped products under complaints and inquiries.

 

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Kabushiki Kaisha DNAFORM

Company Name: Kabushiki Kaisha DNAFORM
Head Office: Tsurumi-ku, Yokohama-shi,Kanagawa-ken
Business: Distribution of various clones, gene expression analysis, nucleic acid detection related products, custom oligo synthesis, etc.
Website: https://www.dnaform.jp/ja/