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.