Are you relying on staff to complete Design History File (DHF) checklists?
Are you relying on staff to maintain document lists and Device Master Record (DMR) binders?
Are you having a difficult time complying with FDA 21 CFR Part 820?
We offer a solution that simplifies device history management and maintenance.
Imagine one place for all your device history. No more nightmares maintaining spreadsheets and huge paper binders for each product. With our solution the staff involved in the design history process load documentation into PLM instead of storing on network drives and hardcopy files. If you already have a PLM system, you can easily use it to manage your Product Life!
Let’s talk about a simplified approach to managing a products DHF and DMR.
Employees involved in the device creation and documentation often become confused with terms like DHF, Design Input, Design Transfer or Device History Record (DHR). Even though they’ve been trained and read your company’s Design Controls, they don’t recall if Functional Requirements are part of the Design Input or the DMR. When uploading a document with our solution, the employee simply selects the product and document type and its placed in the appropriate category of the product’s DHF.
We offer a solution that turns your DHF and DMR checklist into automated DHF and DMR management.
When a user uploads a document such as a Requirement, User’s Manual or Test Procedure, it’s placed in the appropriate category of the product’s DHF. This eliminates errors and takes stress off Engineering, Manufacturing and the Quality Department. Let your PLM system work for you. Instead of using resources to manage DHF and DMR checklists use those resources to audit records and ensure employees are following Design Controls and procedures.
With TriStar’s Intuitive & Dynamic Windchill Dashboards solution you have the ability to show the status of a products DHF, DMR and DHR on one screen. This is very useful during an FDA audit. From there you can drill into product changes and history.
Traceability & Visibility
With our simplified DHF solution, traceability is no longer an issue. You can easily access the actual DHF Records that document your product’s history throughout the development process with revision control. You can show the DMR defines your product. Visibility is of the utmost importance! It’s a fact that most companies only report on it at the end, but cannot track how they are doing during development.
The DMR can be transferred to manufacturing or a subcontractor for fabrication, testing, labeling and shipping. Evidence that each lot or batch was manufactured in accordance to the DMR can be stored as the Device History and displayed in Windchill as your products (DHR).
Click Here to Watch This Webinar Replay.
In this webinar replay, explore how to Manage FDA Medical Device Compliance in Windchill!
- Medical device manufacturers have an arduous process of managing all the relevant data (documents, BOM’s, drawings, ECN’s, etc.) of the DHF, DMR, DHR to ensure passing audits by the FDA
- See how Tristar is taking a new approach not only to report on this data, but actually dynamically collect, manage and give Dashboard status throughout the product development process
Guest Author: Shawnda Zook, TriStar Senior Application Engineer
Let us know what questions you have, and if you’d like to request your TriStar, Intuitive Windchill Dashboard! 1-800-800-1714