Arena PLM and QMS

My company uses Arena for document control and for managing quality processes. This includes employee training, change control, NCMR, CAPA, etc. Arena is Part 11 compliant for electronic signatures which allows us to streamline approval processes and cut down time for releasing documents. Our entire organization uses Arena, although some functions utilize it more than others.

BOM management and issuing ECOs. Helps to easily manage complex BOMs.

I use Arena PLM in my organization to manage the product part numbers, specifications, BOMs, etc. The implementation of Arena has provided reliable revision control for all documentation, which has been especially important when working with our contract manufacturing and product distribution partners. Arena also provides us with a way to categorize our item numbers by type, which has been very helpful.

We use Arena PLM and QMS for our main document control. Having all our documentation in one spot makes it easy to use and update as needed

Arena offers a highly efficient and expedited means of accessing an extensive array of critical documentation and essential information, encompassing change control, requirements management, and electronic quality management system (eQMS) functionalities, thus significantly streamlining and enhancing operational processes. Notably, the integration of these comprehensive tools into the workflow emerges as a particularly remarkable facet of improvement, with documentation management standing out as a notably prominent area of advancement resultant from the seamless implementation.

Document control

We use PLM to track BOMs at all levels and handle ECOs with suppliers
We aim to use it for all products we produce

As a Medical Device manufacturer, [...] is subject to various FDA Regulations and ISO Standards in order to maintain the Certifications necessary to market our medical devices. The PLM module allows [...] to maintain compliance with the Design Controls and Production and Process Controls requirements; the Arena PLM and QMS module supports the [...] Quality Management System (AQMS) which is regularly audited or inspected by the FDA and the Notified Body, the British Standards Institute.

Since the implementation of the Arena PLM and QMS, [...] has realized an 80% reduction in observations or findings during these audits, as well as a 200% increase in efficiency and productively of our quality processes; e.g., Complaint Handling, Non-Conformances (NC), and Corrective Action, Preventive Action (CAPA).

Using Arena PLM and QMS to construct Quality Processes where information is entered into online forms in Arena PLM and QMS, we have reduced the amount of paperwork and MS Word files by 50%, and dramatically decreased errors and omissions.

Arena PLM and QMS is used in our organization for documents, design and change control. The BOM features are used for finished goods and all sub-assemblies. Arena PLM and QMS is also used for training plans and control, as well as for tracking approved suppliers and supplier items. All quality processes (CAPAs, NCMRs etc.) are also triggered and controlled throughout Arena PLM and QMS. Biggest business problems that the product addresses is Quality events (complaints etc.) and design changes.

Arena is used throughout the company and by most departments and all our divisions, here and abroad. It is also used by our assembly partners for parts selection and supply chain planning. Being a cloud-based solution, Arena permits many gains in time and timeliness of communications while keeping everything available to everyone at anytime anywhere. By communicating designs in real-time, Arena permits us to not only save time but reduce errors and roll out better designs faster. Time to market is key, and Arena has helped us with this. Really appreciate all the help so far, keep up the great work!

Arena PLM and QMS is used as the core tool of our QMS. It addresses revision control, training, and tracking of various processes for us. As a start, it brought our company digital. We previously had a number of dusty filing cabinets being controlled by a few select employees with lock and key. Every iteration or Change had to be meticulously tracked and controlled via excel sheets and Data Drive folders with restricted access. Arena PLM and QMS streamlines all of this and keeps changes, and revisions, out in the open so there aren't any questions as to what is the latest and who is responsible for it. Another problem Arena PLM and QMS addresses is files. Purchasing frequently did not have a spec to purchase what amounts to hundreds of small products from various vendors. A clean and tidy file system, complete with approved vendors and PNs, makes this a much simpler issue to tackle. Lastly is training; while Arena PLM and QMS training is pretty rudimentary, at least it is automated and revision controlled. It is pedantic to tie entire groups of employees to an SOP for their review and sign offs where before someone would have to chase them around and get them to wet sign a training log.

We use Arena to maintain the BOM and change management process throughout the company. It also is used as a database for schematics and assembly drawings.

Arena PLM and QMS is used primarily by the Operations, Engineering, Product Development Teams, along with our CM Partners. Arena ties all of our departments together to ensure everyone is on the same page with our product development, launch to market, and most importantly continual improvements. Without Arena, there would be no control as to how our product is configured and ultimately this could result in severe loss of revenue, lessen our consumer confidence, and our Quality team would find it very difficult, almost impossible, to track potential issues and risks.

Engineering and Supply Chain/Operations use Arena for product lifecycle management down to the component level. Arena allows us to have clear version control and traceability during development and into the production of multiple products and controlled exchange of data with suppliers.

Quality Document Management System and component drawing/bill of materials management. [Arena PLM and QMS] keeps track of our changes and manages phase gate approvals. Not all of our business systems are incorporated into arena such as manufacturing metrics and procurement related pricing information and cost management. It does however allow for documentation of supply chain sources.

Arena is used across the whole organization, we start it off with Engineering and Quality, but departments like Product Mgmt, Project Services, Sales and Supply Chain, all use Arena.

We use Arena across the quality, regulatory and operations departments to control product design and manage the Quality System.

Arena PLM and QMS is used in our organization for the following - Management of our product data (current product structures with component suppliers, updates and revision history, the linkage between different products, etc.). Direct link from Arena to the manufacturing site, which means direct up-to-date data without any emails etc. Direct link from Arena to our ERP system (inventory management, order-delivery chain management, etc.), which again avoids emails, etc.

Arena is used company-wide for ECOs, ECRs, purchasing, and inventory

Itis being used by the whole company to manage our change management system. It allows us to have complete control of our concept and design system.

It helps with BOMs and change orders. Keeps everything nice and organized. I am able to easily reference quality documents and processes, link part numbers and suppliers, train to updated procedures and work instructions, and create easy to navigate change requests and change orders. It really helps to use this product when lots of projects are ongoing simultaneously.

It is being used by the whole organization to ensure document control is tracked for FDA reviews. Specifically, any document that is generated in the process of medical device development must be archived, with a clear paper trail of approvers. Any revisions to such documents must also be archived. Arena serves these purposes well.

We use Arena [PLM and QMS] as our document management system and as a place to store our Bill of materials, supplier information, sourcing information, etc. We also use Arena [PLM and QMS] for our nonconformance and CAPA system. It does a wonderful job [of managing] the change orders that are implemented in the system every day and allows for flexibility when it comes to updating the process flows.

Across the whole organization as a form of document control to support the QMS of the company. Used by R&D, Quality, Manufacturing, Sales, and Executive Team.

We use Arena around the clock to keep track of many items, requirements, documents, etc. What would we do without it? It is also super helpful to use as part of a large team, using scribe to contact other team members across the company about specific items. I love how there are many ways to customize how you view and edit data.