Designing products in SOLIDWORKS is one of the first steps in an R&D process. However, how can you meet the requirements of various certification bodies? Depending on your field of activity, you may need to comply with standards such as:

• FDA 21 CFR Part 11 (Regulations on electronic records and electronic signatures)
• ISO 9001 (Quality management systems)
• ISO 13485 (Quality management in the medical device industry)

A common requirement among these standards is the availability of an audit trail. SOLIDWORKS PDM already provides a history of your CAD file evolution, but did you know that it also offers tools for generating reliable and increasingly advanced audit trails?

What are the Challenges Related to Audit Trail Production in a PDM System for Certification Compliance?

The following concerns and challenges arise when implementing a Product Data Management (PDM) system while ensuring the presence of audit trails. Taking the previously mentioned standards as examples:

1. Integrity and Security of Audit Trails

To begin with, preventing modification or deletion of logs is essential. Audit trails must be immutable and shielded from unauthorized changes. This is a core requirement of 21 CFR Part 11 and ISO 9001/13485.

Moreover, access control and authentication are critical. Only authorized users should have access, and all actions must be timestamped.

2. Compliance with Regulatory Requirements

Traceability of modifications and approvals: Any modification to a document must be recorded with user identity, date, and justification, as per the standards.

PDM system validation: The document management software must be validated to ensure the integrity and reliability of records (21 CFR Part 11).

Archiving and retention of audit trails: Documents and their history must be securely stored and accessible in case of an audit (ISO 13485, FDA).

3. Performance and Data Management

Log volume and performance impact: Continuous activity logging can slow down the system, requiring optimization solutions.

Interoperability with other systems: The PDM must be compatible with other software (ERP, MES, LIMS) while ensuring compliance with regulations.

4. User Training and Awareness

Misuse of functionalities: Lack of training can lead to errors in audit trail recording.

Adapting to regulatory constraints: Compliance processes can be seen as restrictive and may require change management efforts.

In summary, implementing audit trails in a PDM system that complies with FDA 21 CFR Part 11, ISO 9001, and ISO 13485 requires rigorous access management, system validation, data security, and performance optimization. Striking a balance between regulatory compliance and usability is crucial to ensuring effective adoption by teams.

Audit Trails in SOLIDWORKS PDM

Document History

Each document has a history of its evolution. Recently, SOLIDWORKS PDM has recently added more details regarding document access, particularly check-out operations. Document approval details are also stored in this history and can be considered electronic signatures.

System History in SOLIDWORKS PDM Administration

To ensure the integrity of SOLIDWORKS PDM configurations, a system history log is available. This allows auditors to track system changes, with recorded dates and users responsible for modifications.

File Access in SOLIDWORKS PDM

One of the most critical audit trails for security is tracking who accessed specific documents and when. SOLIDWORKS PDM has recently added the capability to log all file access activities, consolidating all operations into a single audit file.

SOLIDWORKS PDM Access Logs

Recently added to SOLIDWORKS PDM audit trails is a log of user login and logout activities. These logs include user connections, workstation details, IP addresses, applications used, and even connections from external systems.

SOLIDWORKS PDM Archive Server Activity Log

SOLIDWORKS PDM compiles archive server activities into a log file. If system errors occur, they are recorded in this log, making it an essential tool for error analysis and troubleshooting.

SOLIDWORKS PDM Client Log File

Each SOLIDWORKS PDM client collects information in a log file, recording communication errors, connections, and disconnections.

Key Takeaway: Audit Trails in SOLIDWORKS PDM as a Pillar of Regulatory Readiness

Audit trail management is a key factor in ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, ISO 9001, and ISO 13485. SOLIDWORKS PDM provides a comprehensive set of tools to ensure data traceability, integrity, and security. With advanced features like document history, access logs, connection tracking, and server/client logs, transparency and regulatory compliance become easier to maintain.

By adopting these tools, companies can enhance quality control, streamline audits, and meet the strict requirements of certification bodies. However, to fully leverage these capabilities, access management must be optimized, systems must be validated, and users must be properly trained. By combining rigor, security, and efficiency, SOLIDWORKS PDM becomes a major asset for compliant and efficient engineering data management.

References

ISO 9001 – Retrieved from: https://www.iso.org/standard/62085.html

FDA 21 CFR Part 11 – Retrieved from: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11

ISO 13485 – Retrieved from: https://www.iso.org/standard/59752.html

Have you been using SOLIDWORKS for years and want your skills to be recognized accordingly? Earning SOLIDWORKS certifications validates your expertise and can potentially open new career opportunities. Moreover, if you have a SOLIDWORKS license with an annual subscription, these certifications are free.

Why Obtain SOLIDWORKS Certifications?

As a recruiter within the team of SOLIDWORKS specialists at Solidxperts, I pay special attention to these qualifications when reviewing applications. Certified candidates are the first ones I contact when I have a position to fill. A few years ago, I received over 75 applications for a position, and my primary selection criterion was the CSWP certification. Standing out in the job market is just one benefit. Here are several other compelling reasons to pursue SOLIDWORKS certification:

• Professional recognition: They are highly respected in the industry and provide tangible proof of your skills.
• Skills validation: They confirm your mastery of SOLIDWORKS, a valuable asset for reassuring potential employers.
• Increased visibility: Displaying your credentials on your LinkedIn profile enhances your chances of being noticed by recruiters.
• Access to more qualified positions: Some companies require specific certifications for advanced roles.
• Proof of professional commitment: Obtaining certification demonstrates your willingness to improve and keep up with evolving technologies.

How to Obtain Your Certification for Free

Before diving into how to prepare, it’s worth knowing that certification exams are free if you have an active SOLIDWORKS subscription. Visit SOLIDWORKS Certification Subscription Services Offer for more info on eligibility and sign-up steps.

Skills Assessed in SOLIDWORKS Certifications

SOLIDWORKS certification exams are known to assess several key skills, including:

• Complex part and assembly design: Advanced use of 3D modeling tools.
• Configuration management: Creating and managing design variations within a single file.
• Stress analysis: Using simulation tools to evaluate design performance.
• Advanced feature utilization: Mastery of sheet metal, surfacing, and mold tools.
• Creating detailed drawings: Producing precise technical drawings with annotations and tolerances.

All certifications assess different skills. The CSWP (Certified SOLIDWORKS Professional) is one of the most recognized certifications. It demonstrates your ability to model complex parts and effectively assemble your designs. For practice, you can refer to this resource: CSWP Sample Exam.

As for the CSWE (Certified SOLIDWORKS Expert) is intended for seasoned users aiming for the highest level of SOLIDWORKS distinction. It represents advanced mastery and can even justify a salary increase. Learn more here: CSWE Certification Details.

In addition to CSWP and CSWE, several advanced certifications are available to further specialize your skills:

• CSWPA-SU (Certified SOLIDWORKS Professional – Surfacing)
• CSWPA-WD (Certified SOLIDWORKS Professional – Weldments)
• CSWPA-SM (Certified SOLIDWORKS Professional – Sheet Metal)
• CSWPA-DT (Certified SOLIDWORKS Professional – Drawing Tools)
• CSWPA-MT (Certified SOLIDWORKS Professional – Mold Tools)
• CSWPA-EP (Certified SOLIDWORKS Professional – Electrical Professional)

These certifications allow you to deepen your skills in specific areas and strengthen your technical expertise.

Tips for Succeeding in SOLIDWORKS Exams

To maximize your chances of success in SOLIDWORKS certification exams, here are some practical tips:

• Practice regularly: Familiarize yourself with the SOLIDWORKS interface and practice solving complex problems.
• Use official resources: Study guides and sample exams provided by SOLIDWORKS are invaluable for understanding the question format.
• Manage your time effectively: During the exam, start with the questions you are most confident in to save time.
• Master keyboard shortcuts: They can improve your speed and efficiency during modeling.
• Focus on key features: Exams often focus on essential skills such as sketches, assemblies, and drawings.

Recommended Learning Resources

To effectively prepare for SOLIDWORKS certifications, several resources are available:

• Official video tutorials: SOLIDWORKS offers detailed videos explaining key concepts and advanced techniques.
• Official study guides: These documents detail exam topics and provide practical exercises.
• Online forums and communities: Engaging with other candidates or certified professionals can offer valuable tips and insights.
• Training platforms: Sites like MySolidWorks offer online courses specifically designed for certification preparation.

Steps to Add a Credly Badge to Your LinkedIn Profile

By successfully completing a SOLIDWORKS certification, you can obtain a digital badge via the Credly platform. This badge provides a verifiable and shareable proof of your skills, which you can easily integrate into your LinkedIn profile, online resume, or email signatures. It enables recruiters and employers to quickly validate your skills and enhances your professional visibility. Note that the training you complete with Solidxperts will also grant you a Credly badge that you can display.

Learn more on our website: Solidxperts Credly Badges.

An Investment of Time, but a Worthwhile One 

Adding SOLIDWORKS certifications to your resume and LinkedIn profile is a strategic investment for your career. These credentials enhance your professional credibility, validate your technical skills, and increase your chances of being noticed by recruiters. If you have an annual subscription, don’t miss the chance to earn these valuable certifications for free. Reach out to Solidxperts today to start your preparation.

Certification Preparation with Solidxperts

To maximize your chances of success, Solidxperts offers training tailored to your needs. Whether you are a beginner or an advanced user, these courses will help you strengthen your knowledge and effectively prepare for certification exams. Our trainers have earned these qualifications themselves and are well-equipped to guide you to success. Explore the available course plans on Solidxperts Training page or simply contact us to plan customized training to suit your needs.

In the field of computer-aided design (CAD), time is a precious resource and every gesture counts. SOLIDWORKS is a recognized leader in this industry. It offers a multitude of tools designed to facilitate the work of engineers and designers. Among these tools, SOLIDWORKS breadcrumbs have emerged as an essential feature to simplify navigation in complex assemblies. But what exactly is breadcrumbs? Why has it become indispensable for many SOLIDWORKS users? In this article, I invite you to discover the history, benefits and best practices to make the most of the breadcrumbs feature, and thus reduce repetitive mouse movements which, in the long run, can lead to significant fatigue.

We’ll explore together how this tool can transform the way you work by improving productivity and reducing errors. Whether you’re a seasoned SOLIDWORKS user or a beginner looking to optimize your workflow, this comprehensive guide will provide you with practical keys to getting the most out of breadcrumbs. Get ready to rediscover your SOLIDWORKS interface and take control of your assemblies like never before.

A Personal Experience with SOLIDWORKS Breadcrumbs

From the very beginning with SOLIDWORKS, I was confronted with the challenges of navigating increasingly complex assemblies. Between the drop-down menus, the overloaded toolbars and the unintuitive creation tree, I often wasted a considerable amount of time looking for the component I wanted. This situation was not only frustrating, but it also caused repetitive fatigue due to the many clicks and mouse movements.

The discovery of the breadcrumbs in SOLIDWORKS radically changed the way I work. With one click, I was able to visualize the complete hierarchy of my assemblies, quickly identifying subassemblies and components without having to manually navigate through an often-messy tree. This time saving has resulted in a reduction in my mouse movements by a factor of 2 to 3, allowing me to focus on the creative side of my projects. Today, the breadcrumb trail has become an indispensable ally in my daily professional life. I am convinced that it can bring the same benefits to each of you.

What is the History Behind the Breadcrumb Trail in SOLIDWORKS?

Introduced in 2016, breadcrumbs came to meet a growing need for simplification in the use of SOLIDWORKS. Prior to integration, navigating assemblies required many clicks in a design tree that was often difficult to interpret, especially for projects with a large number of parts and subassemblies. Users then found themselves going back and forth incessantly, increasing the risk of errors and slowing down the design process.

With the introduction of breadcrumbs, SOLIDWORKS has provided an elegant solution to this problem by providing a clear and dynamic hierarchical view of an assembly’s structure. This tool, which takes its name from the legend of Ariadne and its thread that allows you to find your way through the maze, allows you to visualize immediately the position of a component in the entire assembly. This feature has not only improved navigation but also helped to significantly reduce the time spent searching for items. It made the design process smoother and more intuitive.

The Benefits and Usefulness of Breadcrumbs in SOLIDWORKS

There are many benefits to adopting breadcrumbs that go far beyond just browsing:

• Simplified and Visual Navigation: The main advantage of breadcrumbs is its ability to provide a clear visual representation of the assembly hierarchy. By displaying the path traveled, it allows users to quickly find their way through complex structures. In other words, this overview makes it easier to understand the structure of the model, accurately indicating the relationship between the different components and subassemblies.
• Time Saving and Reducing Fatigue: By eliminating the need to click endlessly in the creation tree, breadcrumbs save valuable time. Fewer clicks also mean a significant reduction in muscle fatigue from repetitive motions. For professionals who spend long hours in front of their screens, this optimization is a real asset to maintain productivity in the long term.
• Efficient Management of Complex Assemblies: In large-scale projects, where hundreds of parts and sub-assemblies are present, it becomes crucial to be able to navigate efficiently. The breadcrumb trail offers a simple method to explore these complex structures. Making it easier to manage configurations and verify relationships between different elements. This feature allows you to quickly identify potential breakpoints or errors in the assembly.
• Improved User Experience: By making the interface more intuitive, breadcrumbs contribute to a better user experience. Fewer navigation errors, an immediate understanding of the assembly structure and a reduction in frustration when searching for components significantly improve working comfort. An ergonomic interface is essential to unleash the creative potential of designers, allowing them to focus on innovation rather than technique.
• Facilitating Team Collaboration: When multiple people are working on the same project, clear, shared navigation is a must. The breadcrumb trail provides a common reference for all team members, facilitating communication and coordination during revisions and changes. This makes it a valuable tool for collaborative environments, where every second counts to meet delivery deadlines.

How to Optimize the Use of Breadcrumbs in Your Workflow

To fully realize the potential of breadcrumbs in SOLIDWORKS, it is essential to adopt a few best practices that will maximize its benefits:

Quickly Navigate Assemblies:

Get into the habit of using breadcrumbs to jump directly to the components you want. Rather than browsing the Creation Tree, click on the items displayed in the breadcrumbs to immediately return to the section you are interested in. This method speeds up navigation considerably, especially in large assemblies.

Associate Breadcrumbs with Keyboard Shortcuts:

Combining breadcrumbs with custom keyboard shortcuts can further improve the efficiency of your workflow. By assigning specific keys to common functions, you can access the tools you need faster, reducing the time spent searching for the right option. A perfect mastery of keyboard shortcuts is a real lever to optimize your productivity on SOLIDWORKS.

Customize Display and Settings:

SOLIDWORKS allows for flexibility in the configuration of the user interface. Take the time to explore the options for customizing breadcrumbs to tailor it to your specific needs. You can change the layout, icon size, and colors to make navigation more intuitive and enjoyable. A personalized interface is always better adapted to the particularities of each project and each user.

Exploiting the breadcrumbs in Configuration Management:

Complex projects often involve managing multiple configurations. The breadcrumb trail can be used to quickly visualize the differences between these configurations and identify the changes made. This approach makes it easier to compare and validate different versions, reducing the risk of errors during updates.

Train and Involve Your Team:

Feel free to share your tips and train your colleagues on how to use breadcrumbs. A well-informed team trained in SOLIDWORKS optimization will benefit from increased cohesion and considerable collective time savings. Hold training sessions or hands-on labs to familiarize everyone with this feature. The dissemination of good practices is an investment that will pay off in the long term.

Incorporate Feedback and Continuous Improvements:

Finally, it is essential to adopt a continuous improvement approach. Take the time to gather feedback from your employees and adjust the use of breadcrumbs according to the specific needs of your projects. A regular analysis of productivity gains and any difficulties encountered will allow you to refine your working methods and fully exploit the potential of this tool.

Tips and Tricks for Efficient Navigation

To get the most out of SOLIDWORKS breadcrumbs, here are some additional tips:

• Practice and Familiarization: As with any tool, the key to success lies in practice. Take some time to get used to the interface and experiment with different configurations to discover which ones work best for the way you work.
• Documentation and Updates: Check the official SOLIDWORKS documentation and release notes regularly. Software developments often bring new features or improvements that can further optimize the use of breadcrumbs.
• Use in Collaborative Projects: When it comes to working in a team, share your tips and custom configurations. Good communication on the use of this tool can significantly improve coordination between project members.
• Leverage Online Resources: Many tutorials and forums dedicated to SOLIDWORKS are full of practical tips and tricks shared by other professionals. Feel free to check out these resources to discover new ways to use breadcrumbs.

Now it’s Your Turn to Get the Most Out of SOLIDWORKS Breadcrumbs

The breadcrumb in SOLIDWORKS is much more than just a navigation tool. It represents a real revolution in the way complex assemblies are managed, by offering a clear and intuitive view of the component hierarchy. By significantly reducing mouse movements and optimizing the time spent searching for items, it allows users to focus on what matters most: design and innovation.

Adopting the breadcrumb trail means choosing a more ergonomic interface, which not only improves individual efficiency, but also collaboration within a team. By combining this functionality with keyboard shortcuts, extensive customization and fine-grained configuration management, you’ll be able to transform your workflow and meet the challenges of the most ambitious projects.

In summary, whether you are an experienced user or a beginner in the world of SOLIDWORKS, integrating breadcrumbs into your daily work is a powerful lever. It will increase productivity, reduce fatigue and avoid navigation errors. Don’t wait any longer to explore all the possibilities offered by this tool. Contact our team to learn how to make your work environment a space where every gesture contributes to the excellence of your achievements.