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1 Whitepaper Reduce Regulatory Delays by Formalizing Design Control Processes

2 Reduce Regulatory Delays by Formalizing Design Control Processes The path to market for a medical device is fraught with potential obstacles and pitfalls. And the seemingly Herculean feat of achieving and maintaining regulatory approval looms as an especially imposing task for many medical device manufacturers. But as daunting as the prospect of working with regulatory bodies might seem, it is unavoidable. Failing to fully comply with them can lead to serious and costly delays in delivering new products and updates the existing product, as those require DHF/DMR updates and sometimes RA submission. One of the key strategies to successfully navigating the regulatory pathway, however, boils down to being prepared, organized, and thorough. And while this advice may seem obvious or simple, its importance can t be understated. Luckily, effective product lifecycle management (PLM) solutions, such as Arena PLM, can help to facilitate proper management of quality documentation in order to ease the pains of the regulatory approval process while accelerating time to market. Quality Management Systems According to the quality system regulation (QSR) known as 21 CFR Part 820, medical device manufacturers must implement and maintain certain measures to ensure that the devices they make perform as intended. In essence, this regulation requires manufacturers to tightly control a product s design including changes that might be made throughout the development process by carefully specifying the steps and procedures that make up each design phase. It also mandates that companies provide documentation to demonstrate compliance, specifically in the form of a design history file (DHF) and a device master record (DMR). Whether a company submits a 510(k) or premarket approval (PMA) application, it must be prepared to readily furnish the appropriate QSR documentation and additional details to FDA upon request. The same is true for FDA inspections. The catch with inspections, of course, is that it s not always possible to know exactly what information FDA may seek. Source: FDA But it is possible to make sure everything is in order and organized internally should a request arise from either an inspection or the regulatory approval process. If all pertinent documents are cleanly maintained and easily accessible at any time, and if all quality management system (QMS) components are in place, full compliance with required regulations can be streamlined, stress can be minimized, and approval-related delays can be reduced or minimized. 1

3 The Importance of DHFs and DMRs When it comes to demonstrating compliance with 21 CFR Part 820, certain design elements are crucial among many other critical elements: the design history file (DHF), the device master record (DMR), and Change & Document controls. The DHF is a collection of documents generated throughout the product lifecycle including plans and documents covering procedures related to design input and output that explain the design of the product. As specified in 21 CFR Part (j), which covers design controls, medical device manufacturers must establish and maintain a DHF for each type of device to show that the design was developed in accordance with the approved design plan, as well as FDA s general quality system regulations, at each phase of the product s design, from inception to design transfer. The DMR, which is an allencompassing collection of documents and records (including device specifications, process specifications, quality assurance procedures, and packaging and labeling specifications) is mandated by 21 CFR Part All docs and records, including DHF and DRM, must be carefully managed according to the document control and change management requirements specified in this regulation. The Role of PLM Tools FDA expects DHFs and DMRs to be clean and organized and has the authority to demand that these expectations are met. The agency can respond to more serious infractions, for example, by stopping shipment, issuing a recall, shutting down a product line for investigation, or even shutting down the product line entirely. Furthermore, FDA can request an inspection at any time, with any level of specificity. In light of these demands and potentially serious consequences, it is crucial for medical device manufacturers to be prepared. 2

4 Managing quality documentation and design control processes can be a complex and hard-to-wrangle proposition. After all, the manufacturing of a product tends to involve several steps and a multitude of different parties, from separate departments and internal personnel to external component and service providers along the supply chain. Additional challenges derived from the collaboration of cross-functional teams that have different agendas and speak different functional languages. Every part of the design process must be supported by a document in the DHF, and every document in the DMR must be carefully controlled. Every single step taken by the manufacturer, including any changes made to the design, must be governed by a documented procedure and approved by the appropriate personnel. Because of the sheer volume of people and processes involved not to mention the level of organization required assembling and maintaining a DHF and DMR can be extremely tedious without an effective PLM system in place. Paper-based systems, in which everything must be checked manually and are never real-time, can cause delays while increasing the opportunity for error. Adopting a cloud-based PLM software solution, in contrast, can expedite time to market while facilitating regulatory compliance. How Arena PLM Can Help Serving as an efficient solution for electronically tracking the development of a product, Arena Solutions cloud-based PLM software makes it possible to ensure that all relevant parties including suppliers are in accord and up to speed on a given project. The software solution offers the additional benefit of enabling the consolidation of all compliance information in one centralized location. Arena PLM allows for the management of bill of materials (BOM), DHFs, DMRs, and quality system records to be compiled, edited, and viewed and approved by personnel across a company in an organized, controlled manner. All documents in a DHF can be accurately and reliably tracked from their inception while records in a DHF as well as all the related changes can be carefully managed as well. The software allows companies to streamline and formalize their document-management processes. Also necessary for medical device manufacturers are the change and revision-control features of the BOMControl platform. The software enables compliance with 21 CFR Part 11 and other relevant regulations, which mandate that electronic records be carefully managed and controlled by authorized personnel. The software carefully routes any changes to a document or to the product design to the appropriate personnel for review; the authorized party can then opt to sign off on the changes or not. All changes can be tracked electronically and are approved via traceable electronic signatures. 3

5 PLM Beyond the DHF and DMR Using quality systems regulations as a framework, medical device manufacturers also create internal quality management systems that consist of standard operating procedures (SOPs), work instructions, and policies in which employees must be properly trained. Arena PLM makes it easier to maintain these quality management measures because they can be documented, with each and every change tracked, in a centralized and easily accessible location. PLM serves as a critical tool during audits as well. To ensure compliance with applicable regulations, auditors might ask to review any number of documents stemming from any phase in the design and development lifecycle. The PLM software allows for quick and easy retrieval of requested documentation. In addition to its demonstrated value; in documentation and product record management, product records, streamlining compliance, and traceability, Arena PLM offers the additional advantage of being a cloud-based software as a service (SaaS) delivery model. Personnel need access only to an Internet browser to operate the system as companies do not need to involve their own IT departments or servers. In order to ease or minimize the validation burden from the manufacturer and help comply with applicable regulations such as 21 CFR Part 11, in which medical device manufacturers must ensure that the systems they use to manage electronic records are validated, Arena offers a validation maintenance service (VMS). Each release is validated in-house against a well-defined set of intended uses for each release. Customers are then provided with validation documentation to confirm that updates to the software have, in fact, been validated and Arena PLM conforms to its predefined intended uses. CONCEPT PROTOTYPE PLM SUSTAINING NEW PRODUCT INTRODUCTION (NPI) PRODUCTION 4

6 Conclusion Medical device manufacturing, by virtue of its dealing with life-critical products is rife with challenges. Stringent regulatory requirements burden globally disparate cross-functional personnel. These stakeholders become mired in multiple phases of a lengthy product development cycle while striving to maintain exacting quality standards. Implementation of a cloud-based PLM solution, such as Arena PLM, however, can promote good manufacturing practices while enabling robust product recordkeeping, traceability, change and document management. In turn, medical device manufacturers can effectively streamline operations, nimbly navigate unexpected bumps along the regulatory pathway, and ultimately expedite time to market. 5

7 About Arena Arena invented cloud-based PLM. For over a decade, Arena has been redefining PLM with a suite of cloud applications that enable engineering, manufacturing and their extended supply chains to work better together from first prototype to full-scale production. Arena helps innovative manufacturers bring better products to market faster with cloud PLM offerings that speed prototyping, reduce scrap and help manufacturers collaborate on product changes with strategic partners worldwide. Based in Foster City, California, Arena has been ranked as a Top 10 PLM solution, Top 5 Supply Chain Collaboration application and also holds a spot on the San Francisco Business Times Best Places to Work List for Contact Arena Solutions Foster City, CA P F Cloud. Connected. Content. Makes Making Easier cleantech.wp 6

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