Moria updates its regulatory files with Aletiq

In summary

Using Aletiq, Moria was able to:

✓ Update the technical files of all its products in accordance with the new MDR regulations

✓ Accelerate the creation and updating of DT (Technical File), DHF (Design History File) and DMR (Design Master Record)

✓ Divide the duration of technical developments by 4

✓ Ensuring the digital continuity of data

✓ Ensure FDA 21 CFR Part 820, 11, and ISO 13485 compliance

Founded in France in 1820, MORIA is one of the most recognized companies for its know-how in the manufacture of ophthalmic microsurgical instruments.

With know-how resulting from 200 years of expertise, Moria instruments are designed, manufactured, and finished by hand in France. MORIA is a company on a human scale and dedicates part of its activities to supporting the education of ophthalmologists.

Operational challenges

To meet the new regulations governing the marketing of medical devices, Moria needed to update all regulatory files for its products. Marketing around 10k product references, the redesign of the DHF (Design History File), DMR (Device Master Record) and DHR (Design History Record) was an important project involving all the company's teams:

→ R&D - Product design and DHF constitution

→ Design office - Product design according to R&D specifications

→ Quality - Control of all regulatory documents and files

→ Methods - Description of the manufacturing process and DMR monitoring

In addition, Moria was facing a number of constraints that made regulatory compliance very complicated:

→ Moria's teams are spread over two geographical sites: R&D and quality in Massy and methods and design office in Bourbon l'Archambault.

→ Each team worked on an own data solution without the other teams being able to have simple access to the data (Sharepoint to R&D, EDM to the quality, PDM to the Design Office, Local Server to the Methods)

→ Drafting, validating and monitoring the evolution of regulatory files consumed a lot of time for the teams and involved cycle times that were incompatible with the transition to the new standard.

Moria adopted Aletiq to centralize all of its technical documentation on a platform on which all the company's teams can collaborate.

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Setting up Aletiq

The Aletiq teams went to the two Moria sites in Bourbon L'Archambault and Massy to:

→ Understand current modes of operation and irritants

→ Building a target vision integrating PLM and ERP

→ Build a progressive deployment roadmap including first R&D, EB, then quality and finally industrialization and production

→ Retrieve all the company's historical technical data

After 4 weeks of work, the Aletiq teams were able to clean and load nearly 12k documents, 10k Solidworks files and as many items to prepare the production environment.

All users were finally able to be trained on site 4 weeks after the start of the project and the teams then naturally adopted the application.

The adoption of teams

Change management is now 3 times faster

The Product and Process Evolution Process (MPP) was extremely heavy in administrative tasks, which penalized business agility and hampered continuous improvement initiatives. Several months could pass between a request for change and the application of the associated technical modification.

With Aletiq, everything happens from the platform:

→ Request for evolution

→ Qualification and impact study by the various teams (R&D, BE, Methods, Regulatory, Marketing, Purchasing)

→ Implementation and implementation of the action plan

→ Registration and traceability of the technical modification

→ Notification of regulatory authorities

→ Start of production

Teams are freed from administrative work and can focus on their core business.

100% of regulatory files up to date

During the 4 weeks of deploying Aletiq, the teams loaded all the existing documentation on the platform. Moria was thus able to have a consolidated vision of the regulatory documentary corpus and of the numerous changes to be implemented. Thanks to the workflow module, requests for changes to documents, reviews, signatures and validations have accelerated considerably.

Less than 6 months after the deployment of Aletiq, the DHF, DMR and DHR of the 20 or so product families that Moria markets were up to date with the new regulations in force.

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