Interfacing

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Medical Technology QMS

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Learn how Interfacing can help make your Medical Technology Quality Management System program better

Digital Quality Management Software (QMS) for Medical Technology

Every aspect of the medical technology process must be controlled and monitored as per ISO 13845 and US FDA QSR requirements for medical device organizations. In order to ensure the integrity of the enterprise and to maintain quality assurance, the implementation of additional standards such as ISO 9000 must be pursued. This means installing efficiently designed processes throughout the operation from product development, to supply chain and shipping. By adopting a strong, process-centric culture, your company can smoothly transition from chaotic and ad hoc management systems to a smooth running operation that will increase profits.

A Solution Designed for the needs of the

Medical Technology Industry

Interfacing’s process optimization & automation, SOP documentation digitalization and proactive regulatory vigilance solution, the Enterprise Process Center© Suite has brought about significant time savings with accelerated approval & validation, improved visibility and operational improvements for customers including the following:

End-to-end alignment

End-to-end alignment

The EPC allows life science organizations to easily align departments, regulations, procedures, controls, within a single repository to enable quick and standardized continuous improvements. Our technology allows information fragmenting to build reusable data fragments.

Accelerated approvals and validation

Accelerated approvals and validation

Interfacing QMS solution delivers sustained time saving by reduced training, updating and re-training time. The integrated approval, review and endorsement workflow also helps streamline the validation of new version of the standard operating procedures (SOPs) through fragmented content review and approval cycles to aid decision-making.

Digital Signature and Multi-Factor Authentication

Digital Signature and Multi-Factor Authentication

EPC meets the very stringent requirements associated with compliance for FSA QSR, ISO 13845, GxP programs, and all SOPs and processes are parsed and documented, providing the audit trails meeting compliance with 21 CFR Part 11 Electronic Record and Electronic Signature (ERES) and a host of other regulatory requirements through RSA encryption, vault key story, and multi-factor authentication (MFA)

Improved Speed and Agility

Improved Speed and Agility

Interfacing’s Enterprise Process Center© Suite is fully mobile and digital, providing life science organization with the flexibility of quality documentation readily visible through a variety of means including phone, tablets, graphical and textual to boost employee agility and self-training.

Multi-language support

Multi-language support

Interfacing’s Enterprise Process Center© Suite provides insightful ways to manage global content, whether by automated translation suggestions for all fragments of content, or the ability to collect variance for SOPs by country, region or product-type

Understanding compliance: ISO 9001, ISO 13485, FDA QSR and GxP

We understand that the requirements placed on medical device companies in terms of compliance are very high and that ISO 9001, ISO 13845, FDA QSR and GxP is an essential part of that program. By using our solutions, your company gains the accountability and consistency that will give you a cutting edge over your competition.

Our tools ensure full visibility from end-to-end, all the way from the creation and amendment of a regulation to the approval and revision of the content through to the update and retraining of employees for standard operating procedures (SOPs). We see the full lifecycle management as moving parts of a complete ecosystem and that’s why are unique approach that combines regulatory requirements, documents, processes, work instructions, and governance.

ISO 9001

International standard that specifies requirements for a QMS. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify. First published in 1987 by the International Organization for Standardization (ISO). The current version of ISO 9001 was released in September 2015.

ISO 13485

In short, ISO 13485 is an internationally recognized standard that the following countries have adopted: Europe, Canada, Australia and other markets. Excluding Canada, the application of ISO 13485 is not a requirement but is the de facto standard in use today as a measurement of full QMS compliance set forth on medical device regulations.

US FDA QSR

The US FDA QSR (also known as 21 CFR Part 820) was introduced prior to ISO 13485. All medical device companies in the US are required to meet this standard for national distribution but must comply with both regulations in order to distribute devices internationally. US FDA QSR must also be met by international companies wanting to do business with US customers.

Nuanced QMS

Other countries will have their own criteria to meet nuanced QMS requirements. For example while both Brazil and Japan have their own requirements, they are both based on existing US FDA QSR and ISO 13485 standards. On a positive note, these standards achieve harmonized quality management requirements to meet US, Canadian, European and all other QMS standards in effect.

GxP Compliance

Our approach can help with all regulations and compliances related to pharma production and medical devices (GxP, CFR, GCP, GLP, GMP, HIPAA, ISO9001, medical devices regulations, SOX, BITS, CSA, FDA, FedRAMP, FIPS, FISMA, MHRA, NISP DoD, PCI DSS, SOC 2, U.S. SEC 17a-4 among others).

Manage Content

Manage the individual pieces of information, assign owners, and ensure governance through approval cycles, and change requests.

Digital Signature

We fully support digital signature to ensure that the audit trail of all content is secure, time-stamped, with accurate and complete copies of records available for inspection throughout the retention period.

Ensure Transparency

Full visibility to understand where records are used and their applicability. You can also maintain digital content with clear accountability, including roles and responsibilities.

Conduct Impact Analysis

Analyze your records for downstream impacts, and analyze the potential impacts on policies, SOPs, business units and related records.

Digital SOPs

Generate complete customizable output of processes and related records such as regulations in a ready-to-print and exportable Word format. You no longer need to manage SOP on paper! The digital SOP is in-sync all the time.

Approval and Governance Workflow

Integrated and embedded approval workflows to ensure strict control over the change of your records, including validation of changes, evaluation of impacts and highlighting changes.

Encourage Collaboration

By uniting goals and creating a common framework for your teams, they will be able to cooperate strategically, create change requests, and assign tasks to implementers.

Commitment to Compliance

At Interfacing, compliance is at the core of our mission. We continuously strive to help our clients achieve and maintain full regulatory compliance, ensuring their operations align with global standards.

ISO 27001 Certified Excellence

Interfacing proudly holds ISO 27001 certification, reflecting our dedication to robust information security management. This certification underscores our commitment to delivering secure and reliable solutions for our clients.

AWS Partnership for Advanced Cloud Hosting

By partnering with Amazon Web Services (AWS), we ensure top-tier cloud-hosting services backed by proven compliance. AWS global data centers meet stringent standards, including SOC 1 Type II and ISO 27001. For details on AWS compliance with ISO 18345, FDA QSR, and GxP, explore their comprehensive compliance program.

What our customers say matters

Our Testimonials

Orange

Jean-Luc Heloin, Project Director, Orange Business Services

“EPC was the only tool that answered the project’s needs and requirements. We are rolling out corporate-wide to over 300 modelers & 120K employees!”

Pepsi-Cola

Control Officer Team, Pepsi-Cola

“Our auditors gave us excellent feedback on the use of the EPC as part of our GCS implementation initiative. They were particularly impressed with our ability to identify controls and relate them to risks prioritized with the Risk Matrix. They have since recommended our approach to internal GCS compliance as best-practice for other PepsiCo plants.”

Pepsico

Richard Hughes, Director of Finance, Pepsico

“The integration of our internal audit objectives within our business operations is a novel approach that has exceeded our highest expectations in terms of the effectiveness of our compliance initiative. The Global Control Standard implementation program has allowed us to promote a culture of governance and process improvement across the organization”

Price water house Coopers

Alfonso Velázquez Tavira, PWC BAS Manager, PricewaterhouseCoopers

“EPC’s competitive licensing pricing will allow us to deploy the software to about 36,000 expected end users across Mexico in the next two years. We chose EPC over Bizagi BPM, Fuego BPM and Microsoft Biztalk Server because of its wide range of integrated functionality when it comes to process mapping and automation. All of the BPM suites we considered had functionalities that didn’t meet UNAM’s present needs. With Enterprise Process Center (EPC) we chose which modules we needed to address the problems we were facing currently, with the flexibility to extend in the future as UNAM’s process maturity grows.”

Prospera

Michelle B, Technical Writer

“I like that everything can be linked to a process. I like that you can view processes via a process map or detailed format. Great support during planning phase and project manager worked with our team during development. Any questions we had during the project were answered promptly and if we have questions now, we reach out to the support team.”

Qnet

Oscar M. Erickson, Information Technology Services Specialist

The best application for management This system is simple and easy to use with unique features that make this application a vital tool for any management of any company, thanks to its integral functions allows to have a complete overview of the performance of each area of ​​the company, has a friendly interface that facilitates its use and adaptability quickly and safely.”

Rema Tip Top

Corey Lynch, Business Improvement & Compliance Manager, Rema Tip Top

“The automated monitoring feature of the SOP module bridges the gap between ongoing process management and procedural associated documents and is a great aid for compliance purposes, which constantly require up to date information.”

Royal Australian Air Force

Warren Harrison, Business Improvement Manager, Royal Australian Air Force

“The EPC allowed our people to show their processes in an easy to understand format. It fits perfectly with the ISO process approach. Auditors understood the method very easily.”

San Francisco Public Utilities Commission

Andrea Pierce, Business Applications, San Francisco Public Utilities Commission

“Enterprise Process Center is easy to use, requiring little or no training for rollout, therefore, lowering resistance especially by our non-tech employees. It also allows us to easily train new employees with the knowledge relevant to their roles and responsibilities.”

SGI

Laura - Executive Sponsor in Insurance

Excellent tool supported by a great team The tool itself is great – for more robust than what I initially imagined. What I like best is that there is a team at Interfacing that supports us in establishing best practices for using the tool. We are using Interfacing to document the dependencies from an architecture stand point, as well, to do analysis on process models.”

Stuart Wright Pte Ltd.

Colin Stuart, Senior Well Engineer, Stuart Wright Pte Ltd.

“In the midst of working on a project, any of us well engineers may require replacement for a number of reasons. The replacement engineer will be thrown in the middle of a project, and may not be able to understand the project state. However, with the help of the EPC process maps, the replacement will be able to quickly gain a clear understanding of the project. He just has to know where the work left off and look in the EPC to follow-up on the next step. As such, it doesn’t matter who the person is doing the work; as long as the process is mapped out, the skills are there, and any relevant person can follow through on the entire project. We have found the right tool to make our company a leading-edge consulting engineering business; we even incorporated EPC process shapes in our logo.”

Tennant Company

Tennant Company Team

“We are very impressed with EPC’s functionality and ease of use. We look forward rolling this out across our enterprise.”

Unisys

Mike Hutchinson, VP & General Manager of IMS Worldwide, Unisys

“Our search produced approximately 35 companies that looked promising. After further review, we eventually eliminated most, and finally selected Interfacing’s FirstSTEP technology as the one most suited to our initial needs. Enterprise Process Center has helped us roll out a process-based methodology globally so our people provide consistent service and support no matter where in the world. We believe this product has given us a significant competitive advantage while improving relationships with our clients.”

Unisys

Frank Pugh, Director of Global Implementation of IMS, Unisys

“The simplicity that EPC brought to the task made our job much easier and enabled a quick, albeit partial, rollout of our methodology. FirstSTEP® offered a top-down approach to process mapping versus many other solutions that use a complex, cumbersome and abstract bottom-up approach.”

'US' Utility Services

US Spokesperson, 'US' Utility Services

“A key component of the initiative, and a primary tool for the CoE and the business, in general, was a powerful technology that allowed us to model in a collaborative environment and easily validates the work with process owners. Using the Interfacing’s Enterprise Process Center® (EPC), we modeled processes from both an enterprise-wide, value stream perspective and from the day-to-day task perspective. This was crucial not only to our analysis but also for showing value, sustaining executive support and for validating our work with process actors and owners.”

Veridata networks

Alan Bugarin, BPM Business Analyst

“I have used a number of process modeling and document management tools and nothing comes close to Enterprise Process Center in both functionality and ease of use.”

Veridata Networks

Roehl G. Fontanilla, Vice President, Veridata Networks

“Business will always look for ways to improve their processes, but the biggest challenge is to know where to start and how! EPC provides the capability to see the relationships among these processes in a holistic perspective; providing a clear view of areas where improvements can deliver efficiency and realize cost savings.”

VITO management & advise

Vito van der Burg, MENSGERICHTE INTERIM-MANAGER | PROCESSPECIALIST

“EPC is intuitive and easy to use. It is possible to uickly and easily create overview and clarity. Support is very, seems complex, but is not. I can now create overviews in business processes, BPM and QA.”

Alexandru Ioan Cuza University

Laura-Diana Radu, Lecturer Phd

“The software has valuable functionalities, quite intuitive. The design process and features are flexible and increase visibility into process performance. When I had questions or problems, the Help Desk responds rapidly and gives me the necessary support.”

Azelis

Jeremie Lauzier, ICT Manager

Really good to produce SOP The product is Online, no software to install and it is powerful. We make better SOP, we have better communication of new processes and a better understanding of the processes.”

Bombardier

David Orcutt, VP & General Manager of Programs and Customer Support, Bombardier Aerospace

“We have been working with Interfacing Technologies since July 1998. Integrating business units, by aligning practices between different sites, has been facilitated by being able to link all our processes into one integrated framework shared by all managers. We are counting on FirstSTEP® to enable us to simulate anticipated business volumes and efficiently prepare for and manage our growth with tailored action plans.”

E&Y Central America Inc.

Pablo Arrieta, Partner Advisory Services, E&Y Central America Inc.

“Even if we are aware of other companies that compete with Interfacing we have partnered with them not only because they provide a very competitive set of solutions but also because of a relationship built on trust, collaboration and values that have been tested in the good times but also in the difficult ones.”

Equifax

Global Technologies Operations Office, Equifax

“EPC is robust, intuitive and highly collaborative. EPC is an integral tool to enable the delivery of our Global Service Management Strategy.”

Equifax

Dave McCloskey, North American BSM Leader, Equifax

“EPC is allowing us to fill in process gaps that standard flowchart tools could not.”

Exelon Corporation

Exelon Power Team, Exelon Corporation

“The key benefits of using FirstSTEP® reside in its simple, intuitive-yet-powerful methodology. In a merger situation, ‘best practices’ are crucial. Developing the processes to support those practices is an absolute necessity. The quick learning curve for FirstSTEP® allowed members of our team to rapidly and fully get involved in the shaping of our new process based division. Our modeled processes not only served as a strong backbone to our division’s business plan but also empowered all of us to take ownership of our activities and performances.”

Exelon Power Team

Blake McLaughlin, Senior Project Manager, Exelon Power Team

“Our modeled processes not only served as a strong backbone to our division’s business plan but also empowered all of us to take ownership of our activities and performance.”

Freelance Entrepreneur

Armin Fiedler, Senior Project Manager / Management Advisor

“Interfacing offers the full width of an Integrated Management System: full Cloud Solution, Integrates Processes and Documents, Covers all workflow aspects in an IMS, Integrated CAPA and Audit Management, State-of-the-art user experience. In depth, regulatory requirements like FDA 21 part 11 are not only formally covered, but a real added value is created by regulatory intelligence. I overcome typical issues of traditional QMS like missing change readiness and user acceptance.”

International Air Transport Association (IATA)

Sara ARROUN, Senior Manager Quality & Process Improvement

“Great Service and strong relationship I like how responsive the team is, how fast in providing solutions, and how friendly and approachable they are. They provide support in everything ranging from technical issues to process modeling support when I am not able to figure out certain features. I always get my questions answered. The Live Chat is a great channel.”

ICF

Allan Bachan, Vice President

“EPC is very flexible; intuitive; and little training is required. I am u sing EPC for several consulting projects: Solution Blueprinting for IT projects; Performance Measurement and Management Projects; Operations improvement projects.”

Microsoft

Hisashi Sato, Senior Product Manager Microsoft

“[Interfacing’s BPMN Modeler] gives business users the ability to create sophisticated business models with the ease-of-use that Visio is famous for. It allowed me to create connections between flowcharts and build a multi-leveled process framework in minutes.”

Moreland City Council

Bernard Hoehmann, Business Solutions Architect

“Professional company and very competitive Interfacing are able to construct an implementation plan that completely adapts to our needs. The product is highly configurable. I strongly recommend that you consider Interfacing when testing the market. We will create a process library of our business. We also need to construct a framework that relates business processes to risks, costs, owners and approvers.”

Why Choose Interfacing?


With over two decades of AI, Quality, Process, and Compliance software expertise, Interfacing continues to be a leader in the industry. To-date, it has served over 500+ world-class enterprises and management consulting firms from all industries and sectors. We continue to provide digital, cloud & AI solutions that enable organizations to enhance, control and streamline their processes while easing the burden of regulatory compliance and quality management programs.

To explore further or discuss how Interfacing can assist your organization, please complete the form below.

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AI to Transform your Business!

The AI-powered tools are designed to streamline operations, enhance compliance, and drive sustainable growth. Check out how AI can:
• Respond to employee inquiries
• Transform videos into processes
• Assess regulatory impact & process improvements
• Generate forms, processes, risks, regulations, KPIs & more
• Parse regulatory standards into requirements

Learn more about EPC's AI Use Cases
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Document, analyze, improve, digitize and monitor your business processes, risks, regulatory requirements and performance indicators within Interfacing’s Digital Twin integrated management system the Enterprise Process Center®!

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