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.

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.

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

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.

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 PLM and QMS to manage release & revision control, publishing, and access control for component Item specifications and product assembly Bills Of Materials (BOMs) at all structured levels from raw materials, to various sub-assemblies, all the way to finished & packaged products, beginning from new product design conception through current production. The product addresses information records capture, revision control, sharing access & security, and archiving, but Arena PLM and QMS implementation & use is not without tedious labor, recurring costs, and low time-motion efficiency in the user interface design.

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

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.

Some departments use it, others do not. We use this system to work towards ISO 13485 compliance, tracking lots, P/Ns, Design Documents, etc. It helps us to get information out to the entire team so that it is readily available. It also helps to reduce overall required resources for maintaining documentation processes.

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.

[It is] used to track BOMs, suppliers, and ECOs. [It is] used across the R&D, manufacturing, and supply chain groups. The contract manufacturer has access to view ECOs, build documents, and all other necessary information. Arena PLM is especially useful in handling part and component supply chain issues by easily allowing us to add alternate suppliers.

Standard QMS for med device in production and in development. The top-level problem it addresses is document traceability. In detail, it helps with various nuances in up rev of docs, getting approval/auto reminders to approvers, etc. Version control is also good.

Arena is being used across our entire organization to manage and track product-related documentation including drawings, BOMs, and change orders. The ease of use and accessibility it offers has given our company the ability to make innovative changes to our product quickly and efficiently over our various offices around the world.

We use Arena for quality control and is used across the whole organization. It helps us maintain our revision control and change control for effective backtracking of root cause and design verification and validation. It also helps us to keep check of equipment calibration and keep track of decisions pending approvals and helps maintain change control flow.

Arena is currently only being used by one of the operating companies within my greater organization. It is used in the Quality Assurance department to manage Quality Systems including the document control process. Arena is a controlled database and does a great job of enforcing specific privileges when creating or editing electronic records. Quality records and documents often contain sensitive information that only specific personnel should access to read or edit, and Arena aids in solving that administrative problem with relative ease and usability.

It is being used across the whole organization (Marketing, Regulatory Affairs, Quality Assurance, Manufacturing, Sales, Finance, and Quality Control) as a document management system. It addresses the use of using outdated standard operating procedures and labels.

We use Arena for the whole company. Most everything is now electronic since switching to Arena. BOMs, specs, design history file documents (test reports, software docs, etc.). The entire company has instant access to the documents. We easily provide our vendors with BOMs, etc for purchases. ECO review is seamless, our ECO turn around time has decreased. In addition, our customers want to approve certain documents and we can easily provide them (via license) access to certain documents. We no longer have to put a package together to send via email or have them come into our office for signature (as we used to with the hard copy/manual system).

We use Arena for managing our product changes and BOMs. It is used by the whole engineering division. It addresses the need for change management, revisions, BOMs, and change approvals.