BioSistemika

Koprska 98
Ljubljana,  1000

Slovenia
https://biosistemika.com/

• Booth: 1959

 Press Releases

• IVD Software (May 06, 2024)
  BioSistemika offers custom software development services for the life sciences, IVD (In Vitro Diagnostic), and medical industries. With over a decade of experience, the company has successfully addressed hundreds of unique challenges faced by laboratories and laboratory device manufacturers, ensuring compliance with industry standards and regulation, for example ISO 13485, IEC 62304, GxP, and FDA Title 21 CFR Part 11.
  
  Comprehensive Approach to IVD Software Development
  
  BioSistemika’s services cover the entire software development lifecycle, from conception through to maintenance, including critical tasks such as requirements analysis, system architecture design, coding, and testing. The team has a deep understanding of the regulations and standards that apply to specific medical and IVD devices and follows them throughout every stage of the software development life cycle. They maintain well-established quality assurance processes and conduct detailed software validation to ensure compliance and reliability. At deployment, the client receives all software-related documentation prepared in audit-ready format.
  
  At the core of every project is the development of intuitive, high-quality software that seamlessly integrates with existing laboratory workflows. The focus is not just on creating functional software but also on enhancing data integrity, facilitating smooth data management, and ensuring the software solutions are future-proof and scalable to adapt to the evolving needs of the medical and diagnostic fields.
  
  Moreover, BioSistemika's commitment to quality is evident in its project management practices. Utilizing state-of-the-art project management tools, the team ensures timely project delivery while adhering to best practices in lean software development. This methodical approach reduces risks and leads to the successful implementation of complex projects that require high levels of customization and rigorous testing protocols. Deep engagement with client teams ensures transparent and constant communication throughout the project lifecycle and allows for continuous refinement and adaptation of the software to meet specific operational needs and emerging challenges.
  
  BioSistemika's technological expertise spans various platforms and languages, including C#, .NET, and ASP.NET Core for backend development and Angular, TypeScript, and React for front-end development. This versatility allows the creation of robust solutions that are not only compliant with IVD regulatory requirements but also aligned with the latest innovations in software technology. Read more about BioSistemika's competencies here.
  
  High Security and Seamless Hardware Integration
  
  Their solutions are designed to ensure high data integrity and security, which are paramount in medical and diagnostic applications. Additionally, BioSistemika is adept at integrating software with complex hardware systems, a common requirement in the medical and IVD device sector, where software often needs to interact seamlessly with diagnostic instruments and other medical devices. Whether it’s simple serial connections or complex integrations, BioSistemika’s expertise ensures seamless functionality across all system components, enhancing the overall utility and efficiency of the diagnostic processes.
  
  Partnership for Your Competitive Advantage and Future-Proof Solutions
  
  BioSistemika's IVD software development services represent a synthesis of interdisciplinary knowledge, advanced technical skills, deep regulatory understanding, and a client-centric approach. This blend ensures that laboratories and device manufacturers are not just equipped with software that meets their current needs but are also prepared to evolve and adapt to future technological advancements and regulatory changes. BioSistemika's commitment to innovation, quality, and client satisfaction makes it a preferred partner for IVD software solutions, continuously pushing the boundaries of what can be achieved in the digitalization of diagnostics and laboratory environments.
  
  For more information on how BioSistemika can enhance your IVD software capabilities, you can visit their website, booth #1959 at the ADLM Expo, or contact their expert team directly (team@biosistemika.com). 
  
  
  
  
   

• Navigating the transition from RUO to IVD software (May 06, 2024)
  Research Use Only (RUO) products are intended for preliminary scientific research and are not for use in diagnostic procedures. These products are pivotal in early-stage experiments where the primary goal is to explore new scientific ideas without the constraints of regulatory oversight. In contrast, IVD software is designed for use in diagnostic tests performed on samples from the human body. Such software must comply with regulatory standards, ensuring reliability, accuracy, and safety in clinical diagnostics.
  
  Upgrading from RUO to IVD
  
  Transitioning software from RUO to IVD involves significant enhancements in both the software’s architecture and its compliance with global regulatory standards and regulations, such as ISO 13485 and FDA Title 21 CFR Part 11. Key changes typically include implementing robust data security measures, enhancing traceability, and ensuring precise error handling and validation processes.
  
  Upgrading from RUO to IVD opens up numerous opportunities for research institutions and biotech companies. It enables the commercialization of research findings, allowing them to contribute directly to clinical diagnostics and patient care. IVD applications broaden the market reach and potential revenue streams of products initially developed for research purposes. Furthermore, IVD products typically command a premium in the market, reflecting their verified efficacy and compliance with international standards.
  
  Seamless Transition with BioSistemika
  
  Partnering with BioSistemika ensures a smooth transition from RUO to IVD, leveraging their extensive experience in regulatory compliance and software development tailored for the life sciences and medical sectors. BioSistemika's methodical approach includes a thorough analysis of the existing RUO framework, meticulous planning for IVD-specific enhancements, and strategic implementation to meet regulatory requirements efficiently.
  
  While complex, the transition from RUO to IVD offers substantial benefits for the advancement of medical science and healthcare. With BioSistemika’s proven expertise, laboratories and companies in the life sciences field can confidently upgrade their software products, ensuring they meet the highest standards of clinical use and regulatory acceptance.
  
  Explore one of BioSistemika's case studies with a detailed project showcase here for an example of how it transitions software from RUO to IVD.
   

• Upgrade your software to 21 CFR Part 11 regulatory requirements (May 06, 2024)
  BioSistemika is at the forefront of offering insights and technical solutions for companies transitioning their software to meet the FDA’s 21 CFR Part 11 requirements. As a key regulation governing electronic records and electronic signatures, meeting 21 CFR Part 11 regulatory requirements is crucial for companies operating under the jurisdiction of the U.S. Food and Drug Administration (FDA). This regulation ensures that electronic records and signatures are trustworthy, reliable, and equivalent to paper records and handwritten signatures, making it fundamental for industries like pharmaceuticals, biotech, and medical devices.
  
  Why Compliance is Critical
  
  Devices that comply with 21 CFR Part 11 are essential for any organization looking to market and sell their products within FDA-regulated industries. Compliance ensures that data related to clinical trials, quality control, and patient records meet standards for security, traceability, and authenticity, thereby protecting patient safety and maintaining public health standards.
  
  Key Features for 21 CFR Part 11 Compliance
  
  Software that meets 21 CFR Part 11 requirements should have the following "software features:

  • Authentication: Verification of user identities to ensure that interactions with the system are securely logged and traceable.
  • Audit Trails: Detailed logs that record the date and time of system interactions, providing a traceable history of modifications and data entries.
  • Electronic Signatures: Mechanisms that verify the identity of individuals who sign electronic documents, ensuring that signatures are secure and legally binding.
  • Data Export: Capabilities to export data in formats that are both human-readable and machine-readable, facilitating audits and reviews.

  
  Integrating 21 CFR Part 11 Features into Existing Software
  
  Existing software systems can be upgraded to include 21 CFR Part 11 features, though this process requires a comprehensive evaluation of current capabilities and identifying areas that need enhancement. Upgrading may involve significant changes, especially in data management and security features, to meet the regulatory requirements. Implementing features like audit trails, electronic signatures, and robust user authentication are often necessary steps in this transition.
  
  BioSistemika’s approach not only focuses on integrating these technical features but also emphasizes the importance of having a quality management system (QMS) in place to support compliance. This holistic approach ensures that software not only meets technical requirements but also aligns with broader regulatory compliance goals.
  
  View BioSistemika's detailed guide on this link for guidance on upgrading your software to comply with 21 CFR Part 11. For personalized advice, contact us for a consultation or visit our booth #1959 at the ADLM Expo.
   

• FDA and ISO software documentation in IVD and medical device industry (May 06, 2024)
  BioSistemika understands the pivotal role of comprehensive FDA and ISO software documentation in the development and regulation of medical devices, particularly IVD (In Vitro Diagnostic) devices. As regulatory landscapes evolve, adhering to standards such as ISO 13485 and FDA's 21 CFR Part 11 becomes crucial not only for compliance but also for ensuring product quality and safety.
  
  What is FDA and ISO Software Documentation?
  
  FDA and ISO documentation encompasses all records and evidence proving that a medical device meets the required safety and quality standards. For software integrated into medical devices or used as a medical device itself, it’s essential that the development processes are thoroughly documented to meet specific regulatory requirements set by bodies like the FDA and international standards organizations. This documentation process includes detailed records of software design, development, testing, and maintenance activities.
  
  Why Documentation is Necessary
  
  Adhering to documentation practices is essential for several reasons:

  • Regulatory Compliance: Documentation helps ensure that medical device software complies with relevant FDA regulations and international standards, which is critical for legal market entry.
  • Quality Assurance: Proper documentation processes support the establishment of a Quality Management System (QMS), which systematically improves product quality and safety.
  • Market Trust: Well-documented software development processes build credibility and trust with stakeholders, including regulatory bodies, clients, and end-users.

  
  Key Components of FDA and ISO Documentation
  
  Effective software documentation for FDA and ISO compliance generally includes:

  • Software Requirements Specification (SRS): Details the functions and needs the software must fulfill.
  • Risk Management: Aligns with ISO 14971, documenting the identification, evaluation, and control of risks associated with software use.
  • Software Design and Development Records: Provide a blueprint and detailed explanation of how the software is built and its architecture.
  • Testing and Validation Reports: Confirm that the software meets all specified requirements and functions correctly under all conditions.
  • Maintenance and Update Logs: Document ongoing software updates and maintenance, ensuring the software continues to operate safely and effectively.

  
  Implementing FDA and ISO Software Documentation
  
  Incorporating robust documentation practices into software development can be challenging, especially for companies transitioning to regulatory environments. BioSistemika offers expert consultation and solutions, assisting companies in navigating this complex landscape by implementing and managing effective documentation strategies that comply with FDA and ISO standards.
  
  For more detailed insights into implementing FDA and ISO documentation practices and to understand how BioSistemika can assist your projects, visit BioSistemika’s Detailed Guide.
  
  If your company operates within FDA-regulated environments or needs to adhere to international standards, consider reaching out to BioSistemika for expert guidance. You can meet the team in person at their ADLM booth #1959 for a one-on-one consultation.
   

• Advanced Software Architecture for Life Sciences (May 06, 2024)
  BioSistemika offers specialized software architecture consulting services designed to empower organizations to build robust, scalable, and maintainable applications.
  With a strong focus on aligning software architecture with technical requirements and goals, BioSistemika’s consulting services are indispensable for companies aiming to optimize their software infrastructure.
  
  BioSistemika's approach to software architecture supports complex scientific applications, ensuring that they are not only robust and secure but also flexible enough to handle the rapidly evolving needs of research and clinical environments. The company utilizes a modular architecture, which allows for easier updates and scalability without disrupting existing systems.
  
  Strategic Software Architecture Development
  
  BioSistemika’s team of senior software architects works closely with client teams, offering deep insights into the latest development technologies and trends. This collaboration is aimed at designing software applications that not only fulfill the immediate operational needs but also ensure long-term reliability, security, and performance. Whether the focus is on standalone or embedded software, the consulting process is comprehensive, from initial design to final implementation, ensuring that the software architecture fully supports the client’s business objectives. By minimizing the risks of costly errors and maintenance issues, BioSistemika enhances the overall efficiency and sustainability of software systems.
  
  Key Features of Software Architecture consulting and design
   

  • Modular Design: Structuring software into discrete modules enhances both the maintainability and scalability of its applications. This approach allows new features to be integrated seamlessly and existing ones to be updated with minimal impact on the overall system. Designs that consider future growth and technological advancements ensure that the software remains relevant and maintainable over time.
  • Compliance and Security: Adherence to regulatory standards such as ISO 13485, IEC 62304, and FDA’s 21 CFR Part 11 is a cornerstone of architecture designs. This ensures that all software not only meets global regulatory requirements but also upholds the highest standards of data integrity and security.
  • Interoperability: Given the diverse range of equipment and data systems used in laboratories, BioSistemika prioritizes interoperability in its software solutions. This focus ensures that their software can easily integrate with existing laboratory information systems (LIMS), electronic lab notebooks (ELNs), and other diagnostic equipment.
  • User-Centric Design: Understanding that ease of use is critical, that is why software architecture must be developed with a strong focus on user experience. This results in intuitive interfaces and workflows that enhance productivity and reduce the learning curve for laboratory personnel.

  
  
  Why Choose BioSistemika for Future-Proof Software Development?
  
  BioSistemika's consulting services help organizations build resilient software architectures that support long-term business goals while accommodating future growth and technology shifts. Our strategic approach mitigates risks, enhances maintainability, and ensures your software continues to perform at peak efficiency as new challenges and opportunities arise.
  
  Learn More About Building Future-Proof Software
  
  To gain deeper insights into creating robust software architectures, we invite you to watch our on-demand webinar: How to Build Future-Proof Architecture for Laboratory Software. This session will provide you with valuable knowledge and practical tips directly from our experts.
  
  For direct inquiries or further discussions about your specific software needs, visit us at our booth #1959 at ADLM 2024.