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In this blog, we recap an episode from the eVOTL Insights Podcast, titled “Episode 75: Cary Bryczek, Director of Solutions for A&D, Jama Software.”

Certification and the Role It Plays in the eVTOL Aircraft Market

eVTOL Insights is a leading source of news, information and analysis into the global electric vertical take-off and landing (eVTOL) aircraft and urban air mobility markets. Since their launch in April 2020, they’ve been covering the latest industry news and offering insight for leading executives in the manned and unmanned market, across both passenger and cargo-carrying services. Their in-depth news and intelligence cover a range of different topics, from new company partnerships to industry updates on certification, infrastructure, battery developments and regulation.

As well as daily news, they interview industry professionals as part of their popular podcast series, produce short news videos for their YouTube channel and host virtual networking sessions on the final Friday of every month. To learn more, visit eVTOL Insights

eVOTL Insights Podcast

In Episode 75 of their podcast series, Cary Bryczek, Director of Solutions for Aerospace & Defense at Jama Software, is interviewed by Jason Pritchard, of eVTOL Insights, about the eVTOL aircraft market.

Cary is a member of the International Counsel on Systems Engineering MBSE initiative, a certified Configuration Management Professional (CM2-P), and a member of the Women in Aerospace organization. She is focused on helping companies utilize their data and digital capabilities to deliver aerospace and defense systems and services effectively. Her background has spanned both government civilian, defense contractor, and software vendor roles. At Jama Software, she has helped lead the company in Systems Engineering and Model-Based Systems Engineering domain expertise, as well as sales to help make Jama Connect a globally-recognized requirements management platform.

During this conversation, Cary talks about Jama Connect’s role in the eVTOL aircraft market, how it can help companies with the certification process, and some of the work it has been doing this year.

Click on the Play button below to listen to the episode and see below for a brief preview of that conversation.

Podcast Preview

Jason Pritchard: Hi, I’m Jason Pritchard and welcome to the eVTOL insights podcast. A brilliant show featured guests from companies in the EV tour aircraft and urban air mobility markets. Throughout each episode, we’ll be finding out about their exciting projects, which will help revolutionize the way we travel in future and get their insights into the current state of the industry.

In this episode, I’m joined by Cary Bryczek, director of solutions for Aerospace and Defense at Jama Software. Cary received her BS in electrical engineering from the University of Miami. She is a member of the International Council on Systems Engineering (INCOSE), MBSE initiative, certified configuration management professional, and member of the Women in Aerospace Organization.

Cary is focused on helping companies utilize their data and digital capabilities to deliver aerospace and defense systems and services effectively. Her background has spanned both government civilian, defense contractor, and software vendor roles. At Jama, she has helped lead the company in systems engineering and model-based systems engineering domain expertise, as well as sales, helping to make Jama Connect a globally recognized ALM platform. She has more than 25 years of experience implementing systems engineering in the industrial and aerospace industries with roles at the US government, Lockheed Martin, PTC, and Jama Software. Cary, thank you so much for joining me on the eVTOL insights podcast.

Cary Bryczek: Thanks, Jason, it’s really great to be here. I’m excited to talk to your community.

Jason Pritchard: So we’ve talked a little bit about your background, but are you able to tell us a bit more about that and really how you came to work at Jama software?

Related: Toys to Tools – Keeping Pace with eVTOL Certification Standards

Cary Bryczek: I’ve always been a technology geek. I went the electrical engineering route at university, but then in the working world, I came to find my place doing systems engineering more than anything else. The first part of my career did a lot of work with the government itself and then worked with Lockheed Martin. And then 16 years ago, one of the software vendors that was trying to sell software to our team said, “Hey, Cary, want to come join me at a new company and be my sales engineer?” After I asked him what that was, because I had never heard of a sales engineer before, I decided that it sounded super exciting and I made the career jump.

And then eight years ago, I joined Jama Software, who at the time was positioned as a startup poised to be a market disruptor. And I’ve enjoyed working every day for the past eight years, bringing the most modern tools technology to our customers, working with tiny, innovative startups to big companies. What I enjoy most is bringing the art of systems engineering and the discipline of regulatory compliance to new groups to help them achieve success. No two days at Jama Software are alike for me and I really love that about my job.

Jason Pritchard: Are you up to now tell our audience a bit more about Jama Software, for those of us in the audience that might be unfamiliar with the work that you do or even not necessarily in this industry as well? Are you able to tell us a bit more about the company’s role and really how that plays into the emerging eVTOL aircraft and urban air mobility market?

Cary Bryczek: I think we’re different than any other company that you have interviewed on your podcasts yet. We’re not making super interesting eVTOL vehicles. We’re a tools company. We’re known in the industry as, this market disruptor who has reinvented application lifecycle management. And now we’re the market leader in requirements management. There’s a big need in the eVTOL marketplace to modernize tools and use software as a solution for cloud-native, web-based applications that reduces the IT overhead.

eVTOL startups, they’re wanting to use their investment money in great engineering minds of people instead of building and maintaining tooling, or using decades-old tooling software that’s not purpose-built for aviation, and having to even retain staff on top of it all to keep it working. So Jama Connect is really its software that’s used throughout the certification process, which begins with definition and agreement of the working methods used for certification of the aircraft.

Related: 2022 Industry Predictions for Airborne Product and Systems Development

Cary Bryczek: During this phase, customers are using Jama Connect to capture goals, objectives, marketing information, and even sales information. More importantly, they’re capturing the concept of operations for the air vehicle. But it’s also used to store the process documentation itself that describes the engineering process that the organization is going to use during the entire program and type certification process. The rest of the phases of the type certification process, it closely mirrors the classic systems engineering V model. And then Jama Connect, being an ALM tool, which is used to do things like requirements management, test management, manage traceability, do baseline control and configuration management, Jama Connect is used to author and maintain requirements, safety requirements, and assist in the validation of those requirements by facilitating things like review and approval mechanisms. Our software retains a full audit trail that can be reported on live, instantaneously, or even exported to document format When you have to share that with the ASO or the FAA.

Jama Connect, inside of the application is providing what we like to call it Live Traceability™, but the traceability meaning these the real time views of requirements, safety data, verification and validation, test data, even when that data is originating in other engineering tools. Early on in Jama Software’s career, as it was being developed, is that we wanted to make collaboration an important theme built into our engineering tool. Our founders were engineers themselves, and when they were working on contracts for other companies, they found that they had to do a lot of manual back and forth in review and approval, and things changed, and it was impossible to keep track of that. So we’ve decided that collaborative engineering, as part of the work that every engineer does in their day to day tasks, instead of handing off work to be recorded and filed by dedicated tool staff, is a real big game changer. The more people that you have collaborating and working on the data in the engineering tool, the more efficient the organization has become.

And so our vision is to really make the job of the certification engineer as sufficient as possible, because they’re the ones that, in a lot of cases, they have to look and analyze the audit trail. And then the systems engineers, like the chief systems engineers, they have to do the role of hearding the chickens to make sure that everybody stays on track and analyzing, making sure that everybody really follows that process. So having collaboration mechanisms built right into the software makes it so much easier for engineers to get their work done.

To listen to the entire podcast, visit: Cary Bryczek of Jama Software Talks Certification and the Role It Plays in the eVTOL Marketplace

The Top Six Things You Should Know About TÜV SÜD

In the quest for innovation, product testing, compliance, and safety certifications remain key to accessing markets and gaining customers. No one wants to buy a product, service, or process that hasn’t been thoroughly vetted by an independent body. In the context of global markets, few certifications carry the importance or significance of those from TÜV SÜD, but in the United States, the various companies that are part of the TÜV Association are not widely known. So, what is TÜV SÜD, and why is it so important to product development?

Here are the top six questions and answers about TÜV SÜD:

1: What does TÜV SÜD stand for?

“TÜV” stands for “Technischer Überwachungsverein,” which translates to “Technical Inspection Association” in English. There are several independent companies that are part of the TÜV Association; TÜV SÜD is headquartered in Munich and employs approximately 25,000 people around the globe.

2: What type of company is TÜV SÜD?

TÜV SÜD is focused on protecting people and the environment through rigorous testing, certification, auditing, and advisory services. The company helps ensure regulatory compliance of new and updated technologies, especially in automotive innovation and development, and it functions as a notified body in Europe for medical devices. The TÜV companies trace their origins back to the 1860s when they were first formed to oversee the safety of steam engines.

3: What is the difference between TÜV SÜD and TÜV Rheinland?

TÜV SÜD and TÜV Rheinland are different companies that both provide similar services. All TÜV companies are at least 25.1% owned by the TÜV Association. There are currently six main members of the TÜV Association, all of whom are denoted by the brand “TÜV” plus the regional suffix, such as SÜD or Rheinland. The other TÜV companies include TÜV Nord, TÜV Thüringen, TÜV Saarland, and TÜV Austria.

4: What is a TÜV SÜD Certification?

A TÜV SÜD Certification assures governing bodies and consumers that a product, service, or process has passed relevant safety testing and meets relevant compliance requirements. The certification process is rigorous and comprehensive and involves multiple steps, including steps to review requirements and establish processes followed during development.

5: Why is achieving TÜV SÜD Certification so important?

TÜV Certification is recognized internationally as a sign of quality and thorough review—similar to an ISO or UL certification. Although it originated in Germany, it is regarded globally as evidence that your product, service, or process has attained high standards of safety, quality, and sustainability. With a TÜV SÜD Certification, you can achieve access to additional markets and give your customers peace of mind.

6: Is Jama Connect® certified by TÜV SÜD?

Jama Connect received its first TÜV SÜD certification in 2016. Jama Connect is TÜV SÜD certified for developing safety-related products according to ISO 26262 (up to ASIL D) and IEC 61508 (up to SIL 3). Jama Software is the first vendor that is both SaaS and Agile to receive the certification. In 2019, Jama Software completed additional certification for Jama Connect as a software tool for the development of medical devices according to IEC 62304 and railway applications according to EN 50128.

FDA Inspection

Intro

In Part One of this two-blog series, I shared 5 best practices to prepare your organization for FDA inspection success. Inspections by the FDA can lead to regulatory action and consequences such as warning letters, recalls, and consent decrees. Thus, you want to put your best foot forward to demonstrate the compliance of your Quality Management System (QMS). In this Part 2, we’ll focus on the logistics for running a smooth and efficient inspection.

1: Tone and philosophy

First and foremost, everyone interacting with the FDA should be truthful, professional, and courteous. While this may seem like common sense, it is worthwhile to emphasize. The FDA is there to protect the public good by finding the evidence that your Quality Management System is compliant, so convey that you are there to help them in that goal.

2: Typical Roles

In its aim to demonstrate compliance to FDA regulations, an organization is balancing 3 things: 1) Providing the investigator with requested documents, information, and subject matter experts (SMEs) in a timely manner; 2) Understanding what topics the investigator may request go to next and prepare accordingly; and 3) Keeping a record of what the investigator has examined.

To that end, here are roles to have during an inspection.

Host – Serves as the primary interface with the investigator. This role is typically best served by your Head of Quality, as that individual understands the organization’s QMS and understands the FDA approach. If there is more than one investigator, there should be one host per investigator.
Scribe – Takes notes on conversations with the investigator and what the investigator is examining throughout the inspection. Like the host, assign one scribe per investigator. Folks great at listening and typing quickly make for great scribes.
Back Room lead – This person runs the Back Room, coordinating all the requests coming in, sending requests to the front room, and prepping SMEs. Even more importantly, this person is monitoring what is happening in the front room, anticipating areas of inquiry, and preparing accordingly.
Doc Control – Whether your organization is paper based, 100% with electronic records, or a hybrid, Doc Control is key to retrieving those records in a timely manner and keeping track of what has been presented and reviewed by the investigator.
Tech Reviewers – These folks inspect records before they head into the Front Room to ensure it’s the right document and noticing any issues that the host should be aware of before they are presented to the investigator.
Runners – Individuals who can retrieve information and SMEs as needed.

3: Set up a Front Room and Back Room

Typically a conference room, the Front Room is where activities with the investigator(s) are centralized. Aside from the investigator, Individuals are limited the bulk of the time to the host, scribe, and SME’s.

The Back Room is where document, information, and SME preparation occurs. A large conference room works best, not too far from the Front Room.

4: Communicating between the Front Room and Back Room

Determine how information between the Front Room and Back Room will be shared. This includes document and information requests, as well as the conversations that are occurring. One way that works is a web-conference call (no audio or video) in which the scribe shares a document in which they are typing in live. This shared screen is then projected in the Back Room.

Direct chat channels between the scribe and Back Room Lead are also helpful to communicate information the Host should be aware of, like any delays in document retrieval, etc.

5: Documents/Request Management

Determine how documents and request management will occur. There will be time periods when requests are coming fast and furiously. Whether through a spreadsheet or database, it is important to keep track of what has been requested, when it has been presented to the investigator, and returning any hard copy records after the investigator is through with them.

Providing the investigator with the requests in a timely manner demonstrates that your organization’s QMS is under control and has nothing to hide. Keeping a file of everything the investigator has reviewed is key if there is any action taken by the FDA that requires formal response by your organization. It is vital to know what was specifically reviewed so it can be referenced and referred to as necessary to inform those responses.

Closing

Your organization has worked hard to build and run its Quality Management System and prepare for an FDA inspection. Implement these tips to run an efficient inspection and demonstrate your compliance to FDA regulations.

2022 Airborne Predictions

In many ways, 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of new landscapes and will offer unique challenges, opportunities, and more than likely, many surprises.

As we enter a new year of further changes, Jama Software asked select thought leaders – both internal and external – across various industries for the trends and events they foresee unfolding over the next year and beyond.

This is the fourth part of our five-part series. In this blog, we asked for feedback on product and systems development trends anticipated for the airborne product and systems development industry in 2022 and beyond.

First, we’ll hear from Cary Bryczek – Principal Solutions Architect at Jama Software, Michael Soden – Lead Product Manager for Safety Analysis at Ansys, and Mazen El Hout – Product Manager for Embedded Software for A & D at Ansys. Then, we hear from Vance Hilderman – Chief Technical Officer at AFuzion Inc.

Read our other 2022 Industry Predictions here: Part One – Engineering Predictions, Part Two – Medical Device Predictions, Part Three – Automotive Predictions, and Part Five – Insurance Development Market Predictions.

Airborne Predictions 2022 Part I:

Design Trends

Q: What product, systems, and software development trends are you expecting to take shape in 2022?

Cary Bryczek, Jama Software: In 2022 we will see even more new space launch companies and unmanned aircraft systems (UAS) both enter the market as new companies and those that are already in the market will receive more funding. The commercial demand and competition among companies is driving some very exciting technologies to mature at a rapid pace.

Q: What are the biggest trends you’re seeing in your industry right now? How will they impact A&D product, systems, and software development?

Ansys: Regarding commercial aviation, major trends include the rise of the new air mobility to transport passengers in jammed cities. Those air-taxi services would require air vehicles capable of taking off and landing vertically. Some of them are piloted and others fully autonomous. Most of them rely on fuel-alternative propulsion systems, such as full electric or hybrid propulsion, which means completely new energy and system architectures that should be safe and performant.

Also, fixed-wing transport aircraft are moving in the autonomous direction with single pilot aircraft initiatives at some aircraft manufacturers with high impacts on cockpit display systems. In the defense industry, autonomous systems are also gaining attention with the use case of manned fighter jet supported by unmanned loyal wingman, or a swarm of drones doing formation, involving the use of artificial intelligence and machine learning techniques to extend capabilities of traditional methods of developing control systems and software.

Tool Innovation

Q: From an A&D engineering toolset perspective, what are some of the processes you think forward-thinking firms will be working to leverage or incorporate into their process and why?

Ansys: Key development processes include Model-Based System Engineering, Model-Based Safety Analysis, and Code Generation, to cope with the increasing complexity of next generation systems and reduce their time to market and cost of development. Model-based Design leads to harmonized safety analysis with system and software designs. In addition, cloud-based computing is becoming essential to benefit from high performance computing services and effective storage, easier maintenance, and better collaboration.

Q: In terms of product and systems development, what do you think will remain the same over the next decade? What will change?

Cary Bryczek, Jama Software: It is such an exciting time for technology right now and a lot of what consumer, aerospace systems and defense systems will see in the next decade is already here. We will just see that technology is being incorporated into more and more systems. AI capabilities will do more and more of the heavy lifting such as data parsing so that systems such as the Mars Reconnaissance Rover (MRO) can provide selective data back to engineers faster. The explosion of data is at the heart of everything. It is both a boon and a burden. Those companies that learn to exploit the sheer amount of data being captured from every device and system will be faster to bring their technology to market. Data privacy challenges will likely remain the same as they are now with political climates and some now talking about de-globalization.

Airborne Predictions 2022 Part 2:

Vance Hilderman, CTO, AFuzion Inc:

“It was the best of times; it was the worst of times.”

Surely, Charles Dickens was the earliest aerospace forecaster when he wrote those famous words decades before the Wright brother’s first flight. But was Dickens really channeling the Covid pandemic and today’s aerospace unprecedented changes? Likely not, but the “more things change, the more they remain the same” holds true.

Every two or three years I’m asked to predict next year’s aerospace news. I always chuckle, then provide a disclaimer, “In one baseball season, Ted Williams failed to get on base almost 60% of the time; that made his season the world’s best.” That’s right: 40% success in baseball, and entrepreneurship, is a winning season. With that disclaimer at heart, here’s my “winning season for 2022” predictions:

Supply chain issues are not going away soon. The aviation In-sourcing trend occurring BEFORE Covid is now going to accelerate due to added long-distance supplier (read “offshore”) disruptions. Aero companies will bring back development and manufacturing even faster – expect a record pace giving advantage to those with automated processes and tools already under their control.
Autonomous passenger flight is still a decade away. Sorry – I know that’s not the news you want to hear. Truly great strides have been made and we’re now “40%” of the way there. Safety, airspace management, and certification authority acceptance are all still “in work.” But fear not: if you’re healthy with a 20-year life expectancy remaining, you will see autonomous passenger flights. Absolutely your children will.
eVTOL (electric Vertical Takeoff & Landing) aircraft REALLY are coming. If you can’t spell “eVTOL” or “UAM” you’re taking that Covid isolation too far. But 90% of today’s eVTOL players won’t succeed. Watch for 20-25 of last year’s players to not be in the game at the end of 2022. Who will succeed? Easy: two groups of eVTOL players will succeed: 1) Those early companies with solid funding already received and actually flying aircraft (even if near-final-prototypes), and 2) Longstanding manufacturers with prior success mass-manufacturing either cars or regular aircraft.

If you’re not in group #1 or #2, we simply wish you the best and celebrate your optimism.

Covid forced remote work to be a reality, with great harm to those lacking defined processes and management structures supportive of remote work. In 2022, those aerospace companies with strong planning and remote development capabilities will further distance themselves from competitors. Companies embracing automated (and even semi-automated, but substantially less continuous manual intervention) will see profits and market share increase. Aviation automation tool vendors and aircraft/avionics developers with strong automation culture will be powering the decade ahead, starting in 2022.
After a decade of struggles, experts now say Lockheed is in the driver’s seat, passenger seat, and all the other seats when it comes to fighter jets. And for buyers with ample (read “huge”) budgets, the F-35 is an easy choice. But add improved radar, improved stealth, and improved missiles, and the fighter jet itself is a platform, not the end-all. Ask yourself: what kind of computer or device are you using to read this article right now? Does it really matter or is the software and content more relevant? Exactly.
Yesterday’s shortening time-to-market will seem like a joke compared to 2022’s massively intensifying pressures. New companies, new industries, and even countries new to aviation are all forcing greatly decreased product launch times. Companies providing tools to assist with efficiency (such as AFuzion’s and Jama Software’s DO-178C software development frameworks will see greatly increased sales but also even greater competition (details here: https://afuzion.com/plans-checklists/).
And my final forecast: all the smart people who predicted an end to Covid in 2021 and 2022 (Bill G, are you reading? 😉) will see their predictions to have been as correct as the majority of their prior predictions (really now, “email spam will be eliminated by 2006” – go Google that one – too much time on private jets with other interests). Folks, I predict Covid and its variants will be with us for years. We’ll manage -humans are often frail but adaptable. We’ll get our collective international acts together and form a more cohesive international Covid travel management policy and most of us will be flying as we were before. Except much less business travel (and more pleasure!) because all the predictions above (Read #1 through #6) will REDUCE the need for business travel.

There you have it: hoping I beat Ted Williams record-breaking 40%+ success rate. And that means I hope to see you wherever you are someday, but hopefully for pleasure, not just business!

Thanks for tuning into our 2022 Predictions Series! To see some of the incredible products, software, and systems our customers are building with Jama Connect, visit our CUSTOMER STORIES PAGE.

Design history files were first required by the FDA in 1990 for medical devices. Learn how DHFs impact product teams, and get Jama Software’s DHF template.

In the competitive world of medical device development, medical device companies can’t afford to lag behind the pack. Streamlining the design and approval process is vital to getting products to market in a timely manner. Proper documentation is key to a smooth approval process.

One essential ingredient to medical device documentation is the Design History File, or DHF. While a bad DHF may not result in non-compliance, a good DHF can make the difference between a smooth compliance process and a bumpy one. To create a good DHF that streamlines compliance, design teams should know what to include—and what to avoid—as they go through the entire design and approval process.

What’s a Design History File, and How are They Used by Product Teams Working on Medical Devices?

Before reviewing all of the essential DHF ingredients, it can help to back up and establish what it is and why it’s important.

The Design History File is a collection of documents that describe the design and development activities of a medical device. Its purpose is to demonstrate that the device was developed using the design control process needed to meet FDA requirements.

Figure 1: Design Control Process for Meeting FDA Requirements

The DHF requirement was established as part of the Safe Medical Devices Act of 1990. The act describes the DHF in section 21 CFR 820.30, sub-section (j) as follows:

“Each manufacturer shall establish and maintain a DHF for each type of medical device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the regulations of this part.”

There are two key terms in the DHF requirement: “establish” and “maintain.” “Establish” means that the development team must define, document, and implement requirements. Evidence is found in procedures, work instructions, drawings, and other similar documents. “Maintain” means that the team must review, approve, and update requirements. Evidence of maintenance is typically found in document control or change control systems of a company.

While a comprehensive DHF is vital to the FDA approval process, design teams will realize other benefits of maintaining the DHF, including:

Requirements traceability;
Change control; and
Knowledge preservation and information sharing among key stakeholders.

What is the difference between DHF and DMR?

The DHF is one of three pillars of design compliance for medical devices:

Design controls: The moving parts of product design and development.
Design History File (DHF): The collection of records from design and development activities.
Device Master Record: The “recipe” for product manufacturing once the design is complete.

As one of the pillars of design compliance, the DHF is important, but it cannot hold up the design process on its own. It’s one leg of a tripod, and removing any one of the legs means that the entire design compliance process may tip over. Equally important to the process are design controls and the Device Master Record, or DMR.

What are design controls, and how does the DHF establish the design control process?

Design controls establish a plan to manage new product development; they are the process pieces that guide development along a predictable path to ensure that requirements are met. The Safe Medical Devices Act requires that manufacturers of Class II and Class III medical devices (and some Class I devices as well) implement design controls over the development process.

Design controls include:

Design inputs: The physical and performance requirements for the type of device. May also include types of materials needed, interfaces with other devices, and even packaging required, especially if the device must be sterilized.
Design outputs: Usually the final specifications for the device, typically documented in models, drawings, engineering analysis, etc. Outputs should trace directly back to initial requirements. Design outputs are the basis of the Design Medical Record (DMR).
Design review: A formal review by the design team and any other relevant parties, such as sales, marketing, manufacturing, etc. Documentation of the review should include the date, participants, version/revision reviewed, and results.
Design verification: This process verifies that the design output meets the requirements expressed by the design inputs and that specifications are correct. Documentation of this process must include the date, participants, version/revision reviewed, and the verification method and results.
Process validation: Process validation involves producing the device with a normal, low-level production process to confirm that the device will function as designed outside of the prototype process. Documentation of the process is required for the DHF.
Design validation: In this process, each manufacturer validates device design under specific conditions on small production lots or batches. The DHF documentation must include identification of the design, methods of production, date, and individuals performing the validation.
Design transfer: The process of transferring design into production, distribution, and installation specifications.
Design changes: May be referred to as “engineering change” or “enterprise change,” this process identifies and documents any design changes.
Design history file: This is the formal document prepared for each medical device that includes either all documents generated in product development process OR an index of documents and locations where they are stored.

As you can see, the DHF is one of many design controls, but it also serves as the repository of records of all other design controls. Think of it as the final stop for the information generated by all other design controls.

What is in a Device Medical Record (DMR)?

The third leg in the tripod supporting your compliance process is the Device Medical Record, or DMR. Think of the DMR as the “recipe” that resulted from the design controls to manufacture the device according to design specifications. It’s more than just a production traveler—it will include device specifications, compositions, drawings, formulations, software specifications, etc., as well as production process specifications, including appropriate equipment, methods, procedures and environments, such as clean rooms, humidity controls, quality assurance procedures, and any specialized equipment needed. The DMR will include everything from beginning to end of the production and shipping process, including any relevant installation instructions.

What are some pitfalls to avoid when compiling the DHF?

Many companies make costly and time-consuming errors when creating their DHFs, leading to longer-than-necessary audits and failed FDA inspections. Avoid these mistakes, and you’ll minimize lost time and unnecessary costs getting to market.

Jama Software hosted a webinar led by Quality Centric Consulting to review:

The top DHF errors that are costing you money
How to tackle 21 CFR 820.30 requirements
How Jama Connect™ streamlines the DHF process

Five of the most common pitfalls of the DHF include:

Not having a DHF: Usually small companies strapped for resources will put all their efforts into designing and getting a product to market, with the intention of doing the DHF later on. This could be due to a lack of understanding of what DHF outputs are required.

Chaotic and unorganized DHF: This is more typical in paper-based companies that keep all information in binders, but leave off dates or include unapproved documents, making it impossible to organize at the time of an audit or inspection. Disorganization — whether paper- or email-based — also makes it difficult to manage changes and revisions due to information silos and lack of sharing information.

Including unnecessary documents: Adding business documents, such as supplier quotes, financial information or unused concepts, can bring a flurry of unwanted questions from inspectors. This can also be a symptom of not having a DHF tool or template, as well as a linear process that involves lengthy review and approval times.

Unmaintained DHF: Often companies use either outdated or improper technology for the job. Paper-based systems, email, shared folders with read-write access and the like, are not always effective document controls. This can lead to lost copies of important records, making a DHF non-compliant.

Not traceable to outputs: Without a DHF, it’s impossible to create your DMR, and very difficult to establish your traceability matrix. If design control results are not well documented, easy to locate or current, your DMR will fail to be compliant.

What is compliance management, and how does it help product teams ship on time?

Compliance can refer to a variety of different laws, guidelines, standards, processes, procedures, or other controlling documents, including contracts. Compliance management refers to the intentional process by which designated team members or compliance officers monitor and control design, development, launch, and fulfillment to ensure that all legal, contractual, and procedural requirements are met.

Ideally, compliance management involves both people and a system that is fully integrated across functions of the organization. The more integrated the compliance management in the development lifecycle, the more likely it is to detect potential compliance issues before they cause long-term harm to companies or consumers.

A fully integrated compliance management system can help your product team ship on time or early by keeping all compliance factors top of mind during the design, development, and fulfillment process. When teams are ensuring compliance throughout the entire development lifecycle, unforeseen delays and consumer issues are less likely to derail product success.

To fully integrate compliance management, teams need a development process that includes touchpoints for assessing compliance. The process should include activities such as:

Standard operating procedures
Safety and security procedures
Reporting and documentation
Internal and external audits

Integrating all of these activities will help ensure that teams are fully prepared to establish compliance with applicable standards, regulations, and laws before launch, reducing the possibility of costly delays or failures.

RELATED: A Guide to Understanding ISO Standards

What is compliance control?

Compliance control is a set of guidelines and policies designed to provide a framework for compliance to product teams and stakeholders. These guidelines and policies apply to everyone involved in compliance management—from board of directors to compliance officers or compliance managers to team members.

Common internal compliance controls can include the following:

Published standards, policies, and operating procedures
Training and documented completion of training
Internal audits
Contracts

External compliance controls are those that originate anywhere outside the company:

Laws and regulations
Industry standards
External audits
External risk assessments

What is a compliance management system?

A compliance management system is a program that integrates written documents, processes, functions, controls, tools, and anything else that helps organizations comply with regulations and reduce risks to consumers that arise due to violation of applicable law. While a comprehensive compliance management system will include appropriate tools such as software, it will also clearly define the roles of various stakeholders, including:

Team members
Compliance officers or compliance managers
Board of directors
Internal auditors

The compliance management system will also define processes for:

Assessing and responding to consumer complaints
Addressing results of a compliance audit
Providing relevant compliance training as appropriate
Keeping informed of regulatory change
Taking corrective action when products are found in violation

Why is maintaining compliance so important for product teams working in regulated industries?

Former US Deputy Attorney General Paul McNulty has stated, “If you think compliance is expensive, try non-compliance.” In any industry, non-compliance can lead to fines, product failures, and lawsuits—not to mention the cost of lost reputation, customers, and business.

For teams working in regulated industries, maintaining compliance is especially important as there are often unique safety and regulatory issues at hand. In industries such as automotive, aerospace, and medical devices, one product that fails to meet regulatory or legal standards could potentially lead to the kind of product failure that results in loss of property or human life.

Studies by the Ponemon Institute reveal that non-compliance can cost as much as 2.65 times what compliance costs. What’s more, the institute found that non-compliance costs increased by 45% between 2011 and 2017.

What are best practices for compliance management?

While the specific practices for compliance management will vary according to industry, there are some best practices for compliance management that any product team can use to ensure a successful product launch.

Identify compliance officers: If your company doesn’t have a dedicated compliance officer, identify someone on your team who can at least serve as an ad hoc compliance officer. Identifying the right person (or people) early in the development process will give a central point of contact so that no one is wondering who is in charge of compliance.
Learn relevant requirements: All members of the team should at least have a familiarity with the regulatory and legal environment around product development. In addition, everyone should subscribe to government and industry mailing lists or websites to stay up-to-date on changes to regulations. One study found that regulatory monitoring saved companies an average of $1.03 million.
Create a central repository of requirements: Rather than simply documenting requirements that are relevant only to one team or project, companies should create a central source of information for all compliance requirements, including internal procedures and standards. With one central source for all teams to access and contribute to, teams are less likely to miss requirements in the development process.
Establish traceability between requirements and standards, regulations, and other relevant compliance documents: By documenting traceability between the compliance requirements and project artifacts, product teams create a robust analysis tool that can provide invaluable detail and information for audits and reviews.
Implement tools that support compliance management: While there’s no substitute for having human input and control over compliance management, there’s no question that having the right tools can make compliance a more manageable task. The right tool will support product teams by providing a central source for traceability, requirements management, analysis, documentation, and all related activities.

What makes a compliance program effective?

A comprehensive and effective compliance program will:

Reduce costs: When teams have a program in place for comprehensive compliance management, it’s almost inevitable that the team or company will save money overall.
Improve risk management: Evaluating and assessing risks throughout the lifecycle will improve risk management across the development lifecycle. Good compliance management will help teams identify and assess risks early in the development process.
Keep product development well within organizational GRC framework: An effective compliance program will keep development in compliance with internal controls and the overall organizational GRC framework.
Improve speed to market: When compliance is fully integrated into product design and development, the risk of delays drops, and chances of shipping on time or early increase.

What tools and software can help product teams maintain compliance during the application lifecycle?

A compliance management solution is an important piece of any compliance management system. Within the overall framework of a compliance management system, a compliance management solution will support workflows, self-assessments, surveys, and issue remediation. In addition, intuitive dashboards and charts can provide real-time insights into compliance processes.

How can Jama help teams working in highly regulated industries, like medical and aerospace, maintain compliance during the application lifecycle?

Jama Connect gives product teams the tools they need to integrate compliance management into the design lifecycle. By tracking requirements and giving teams the traceability they need, Jama Connect simplifies compliance management by integrating it fully into the application lifecycle. To learn more about Jama Connect, contact us for a demo.