Arvind Krishnan

Codebeamer – ALM Solution for Manufacturers Creating Regulatory-Constrained Products

April 20, 2022

On April 20, PTC announced that it has signed a definitive agreement to acquire Intland Software. This review was developed prior to this announcement.  We hear all the time that software is eating the world, and it’s true. Software is an integral part of many regulatory-constrained products that we use in our day-to-day lives. And …

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Codebeamer – ALM Solution for Manufacturers Creating Regulatory-Constrained Products

On April 20, PTC announced that it has signed a definitive agreement to acquire Intland Software. This review was developed prior to this announcement. 

We hear all the time that software is eating the world, and it’s true. Software is an integral part of many regulatory-constrained products that we use in our day-to-day lives. And with the increasing role of software, more and more manufacturers are working hard to build out development competencies inside their companies. A part of that is finding a robust way to manage their process of developing software-based smart, connected products throughout the product lifecycle. This is where Intland’s codebeamer comes into play.

Need for Software Management

Managing software is critical and indispensable for companies that manufacture regulatory-constrained products. A multitude of industries, from aerospace to medicine, develop products that include software components. When developing regulatory-constrained products, companies have to adhere to various government regulations regarding the software. Some of these regulations mandate tedious procedures and extensive documentation before a product goes to market.

Companies need to manage their physical products as well as intangible ones—like software codes—if they hope to get the product to market first. Intland’s codebeamer, an application lifecycle management (ALM) platform, can help. This post covers three critical features of codebeamer that empower engineers to improve product development.

Requirements Management

Developing a good product starts with gathering requirements. Requirements can come from a variety of sources, including customers, industry experts, and competitors. As regulatory-constrained products become more complex, so do the requirements. Engineers must successfully track these requirements throughout the product lifecycle. Let’s look at what this process entails and how it impacts software.

The first step in this process involves connecting requirements to software components, tasks, test cases, and so on. Engineers need to know which requirements are allocated to which software component. Then they can identify and get to the correct part of the code to fix issues when they arise.
The second step in this process is requirement satisfaction. Engineers must test and document the software code to meet all requirements. Government regulations mandate that companies report and submit proof that their product meets requirements, was developed using compliant processes and is safe for the users and environment.

codebeamer Advantage

Managing all the necessary documentation is easier with codebeamer. codebeamer can automatically extract all requirement-related information from industry-standard formats such as ReqIF/RIF. Furthermore, users can author requirements inside codebeamer and export them using the ReqIF/RIF format.

In addition, codebeamer allows companies to add regulatory documents, tasks, approval processes, audits, and more, right at the requirement stage. When pointed towards a GIT or similar software repository, codebeamer can extract all the associated software components and link them to the appropriate requirements. codebeamer maintains this link throughout the product lifecycle.

Companies can manage requirements and regulatory needs in one system and enjoy improved efficiency in the software development process. codebeamer’s requirements management feature allows users to trace product specifications from ideation through development, testing, and even operation. As a result, engineers can better manage requirements throughout the product development process.

Out of the Box Regulatory Templates and Custom Processes

Engineers are good at designing and manufacturing products, but they are not always experts in creating regulatory documentation. However, controlled product development, accurately documented audit trails, and testing documentation is key to success in industries that are tightly governed by regulations. Engineers are required to track changes and document development processes that will serve as the basis for the evidence submitted to certification bodies/auditing organizations to achieve compliance

Regulatory documentation adds a necessary burden. Engineers often have to create regulatory documentation from scratch using standard office tools. The process of creating regulatory documentation is laborious and prone to errors. Additionally, managing many files and folders quickly becomes complicated.

Templates make life easier for engineers who design products requiring regulatory approvals. Using these templates, engineers can follow an industry-standard pre-configured process. Along the way, engineers can fill in appropriate documentation at the proper stages of the design process, allowing the ALM solution to manage the rest of the process.

Templates are important, but fusing pre-existing company processes with new ones is also critical for success. Manufacturers have their own set of product development processes. These processes have evolved over time and are optimized for each company, so they aren’t interested in changing them abruptly. However, there are instances where some changes may be necessary, such as when a company develops a new product that requires regulatory approval.

For example, the Apple Watch has a new electrocardiogram (ECG) function that requires FDA approval. Apple may not have a product development process in place for this requirement. Companies in similar situations need a configurable solution that can blend with and supplement their existing IT systems and processes to manage new processes as well.

codebeamer’s Regulatory Templates and Flexibility

codebeamer comes with regulatory templates for medical device software engineering, medical technology (MedTech) quality and audit management, pharma GAMP, Automotive ISO 26262:2018, Automotive ASPICE, Avionics DO-178C, ISO 9001: 2015 QMS, and many more.  These templates come with predefined artifacts, workflows, and baked-in domain knowledge right out of the box. codebeamer’s out-of-the-box templates and customization function save time, reduce engineer fatigue, and minimize errors when dealing with regulatory requirements.

Of course, these templates may not cover all of a manufacturer’s unique regulatory process and documentation needs, so codebeamer allows engineers to create custom templates from scratch. The ALM solution manages these templates, and the entire organization can use them.

codebeamer is a configurable solution that integrates with existing processes and software solutions. codebeamer integrates with manufacturers’ existing PLM solutions. The platform delivers value in areas where companies do not have experience, such as regulatory compliance.

Manufacturers can derive immediate benefits by using codebeamer to address their most urgent requirements. Then, they can take advantage of codebeamer’s flexibility to customize and configure to explore other features at their own pace. Companies can ensure that they are developing superior products that adhere to all government regulations when using codebeamer.

Configurable Solution with Cloud Option

Regulatory approval and customizable processes are not the only issues manufacturers are facing. Many small and medium-sized businesses (SMBs) are now developing regulatory-constrained products with software elements. There is a twin challenge here for the SMBs. They have to deal with the growing complexity of their products just like their counterparts in large enterprises. But unlike the large companies, SMBs don’t have nearly the same resources in terms of budget, human resources, and IT systems.

SMBs may not have the IT infrastructure to implement software and regulatory management solutions. These solutions are typically hosted on large enterprise servers and need a dedicated IT team to manage them. To address the SMBs’ requirements despite their resource challenge, a cost-effective, easy-to-deploy solution is needed.  A readily deployable cloud-based solution fits the need perfectly. These cloud-native solutions can help these companies manage their software development processes.

codebeamer’s Cloud Solution Enables SMBs

Small and medium-sized manufacturers can use codebeamer’s cloud offering to quickly address software development and regulatory issues. codebeamer X is a cloud-based ALM solution delivering predefined, out-of-the-box building blocks that SMBs can get started with easily. It has an optimal set of tools and features that help SMBs quickly adopt best practices without a large initial investment. As a company matures, it can add more sophisticated tools to manage various aspects of software development and regulatory compliance.

Regulatory-Constrained Product Development Improves With codebeamer

Manufacturers developing regulatory-constrained products must incorporate software into their products while adhering to government regulations. codebeamer is a comprehensive solution that makes this easier.

Creating and managing regulatory documents is a tedious, error-prone process for engineers. Engineers also must handle the requirements of increasingly complex products that incorporate software. codebeamer’s templates and ALM solution reduce the time engineers spend establishing and maintaining regulatory documentation. codebeamer also tracks product requirements throughout the product development process.

Manufacturers may lack the proper regulatory document and software product development processes they need to comply with regulations. codebeamer comes with out-of-the-box building blocks that manufacturers can use for new processes. Companies can also use codebeamer’s more sophisticated tools to improve software and regulatory management. SMBs can also benefit from a cloud-based offering of codebeamer, codebeamer X, that offers critical ALM functionality and tools to help developers manage the entire application lifecycle including regulatory audits.. Using codebeamer X, SMBs can manage complexity in their products without a big initial investment. Overall, codebeamer improves the product development process for manufacturers creating regulatory-constrained products.

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