Simplifying Life Sciences Compliance with Helix Core

KB at your finger tips

This is one stop global knowledge base where you can learn about all the products, solutions and support features.

Products-Helix Core

Simplifying Life Sciences Compliance with Helix Core

Challenges with Compliance

The life sciences industry is known for its heavy regulation, requiring compliance from all organizations involved, including medical device manufacturers, healthcare providers, and pharmaceutical companies. Achieving compliance in this industry, however, poses significant challenges. Keeping teams updated on ever-changing regulations is difficult, especially when working with disparate documents. Creating a traceability matrix to demonstrate compliance is usually a manual task, often delayed until a project's completion, making it more complex. Fortunately, there are solutions to tackle these challenges.

How to Achieve Regulatory Compliance

Life sciences organizations must adhere to various regulatory standards such as FDA, ISO, HIPAA, EU, IEC, and SOX. The specific standards applicable to each organization depend on the type of product being developed and its geographical scope. Some common compliance standards include 21 CFR Part 11, IEC 62304 and 60601, ISO 14971 and 13485, and cGMP. Implementing life sciences compliance software like Helix ALM offered by Perforce can greatly assist in meeting these standards efficiently.

6 Benefits of Life Science Compliance Software

Utilizing life science compliance software such as Helix ALM offers a plethora of benefits. Firstly, it helps in mitigating and managing risks throughout the development process by providing full audit trails and instant issue insights. Secondly, it enhances visibility into the development process, ensuring teams are well-informed on requirements and testing statuses. Additionally, it boosts productivity by facilitating seamless collaboration among engineering teams, enables quick coordination of design changes, and allows accurate project progress tracking and scheduling forecasts. Furthermore, the software enables instant tracing of requirements, tests, and issues, simplifying the creation of traceability matrices. It also assists organizations in demonstrating compliance to regulatory bodies by automatically generating audit trails showcasing compliance achievements, test results, and bug resolutions. Lastly, Helix ALM ensures the security of development artifacts, aiding organizations in staying compliant.

Trusted by Leaders in the Life Science Industry

Helix ALM from Perforce has gained the trust of leading companies in the life science industry. By simplifying core processes, driving innovation, and offering a competitive edge, Helix ALM has become a go-to solution for organizations striving to achieve compliance efficiently. The software's capabilities have been showcased in various success stories, highlighting how it streamlines compliance processes and accelerates regulatory approvals for medical devices and other life science products.

From Word Docs to Life Sciences Compliance

Fractyl Laboratories, a medical technology company, faced challenges in compliance while managing requirements in Microsoft Word documents. This manual process hindered their regulatory compliance efforts. However, upon implementing Helix ALM, they achieved CE certification for their Revita™ procedure well ahead of schedule, highlighting the software's effectiveness in expediting compliance processes. Testimonials like these demonstrate the real-world impact of Helix ALM in simplifying compliance requirements for organizations in the life sciences sector.

Stay Ahead in Today’s Competitive Market!
Unlock your company’s full potential with a Virtual Delivery Center (VDC). Gain specialized expertise, drive seamless operations, and scale effortlessly for long-term success.

Book A Meeting To Setup A VDC

Enhancing Collaboration and Efficiency with Perforce Helix Core Reseller Partners

Perforce Reseller Partner Advantages

Partnering with Perforce, the market leader in collaboration and version management, offers numerous advantages. By collaborating with Perforce, reseller partners assist their customers in bringing products to market faster, safeguarding intellectual property, improving collaboration, and increasing efficiency. Perforce's technical vision and commitment to continuous innovation enhance the value reseller partners bring to their customers, open up new market opportunities, and boost revenue streams.

Read article

Meet the Leaders Behind Helix Core - Perforce Management Team

Jim Cassens - Chief Executive Officer

Jim Cassens leads the team at Perforce as the Chief Executive Officer, bringing with him a wealth of experience and expertise in the software industry. With a focus on driving innovation and delivering exceptional products and services to customers, Jim plays a crucial role in shaping the company's direction and success. His leadership ensures that Perforce remains at the forefront of technology, providing cutting-edge solutions to meet the evolving needs of businesses across industries.

Read article

Empowering Teams for Rapid Innovation with Perforce Helix Core

All-in-One Digital Asset Management

Perforce Helix Core provides teams with a top-notch version control system perfect for driving large-scale innovation rapidly. It allows for the storage and tracking of all digital assets, from source code to binary files and IP, facilitating enhanced capabilities for teams to collaborate and build better products faster by connecting them.

Read article

Helix Core: Enhancing Government Product Development with Secure Solutions

Security Solutions for Government Projects

Helix Core offers a highly secure solution tailored to meet the unique software development needs of government organizations. With complete forward and backward traceability, low cost of implementation and ownership, state and federal institutions such as the Utah Department of Transportation, Tennessee Treasury Department, US Department of Defense, and NASA trust Helix Core. This solution ensures secure processes, data integrity, full traceability reports, and management transparency.

Read article

Unlocking Innovation and Efficiency with Helix Core - Perforce Resources

Maximizing Productivity through Version Control

Helix Core, offered by Perforce, is a powerful version control system designed to streamline development processes, enhance collaboration, and ensure code quality. With Helix Core, companies can manage their source code, digital assets, and artifacts efficiently, enabling teams to work seamlessly on projects of any scale. By providing a centralized repository and robust branching and merging capabilities, Helix Core empowers development teams to track changes, maintain version history, and collaborate effectively.

Read article

Welcome to Knowledge Base!

KB at your finger tips

Products-Helix Core