Jama connect

Anselm as the Agent for Jama Connect® Application Lifecycle Management (ALM) Solution

What is ALM, and why do businesses need to implement ALM management?

ALM (Application Lifecycle Management) is a software engineering methodology designed to comprehensively manage the entire lifecycle of applications, from initial concepts and requirements to development, testing, deployment, operation, and eventual retirement. ALM focuses on coordinating and integrating various stages of the software development process to ensure the smooth operation of the entire lifecycle and the delivery of high-quality applications.

 

Why do businesses need to implement ALM systems?

With the surge in the Internet of Things (IoT) and AI applications, industries such as automotive systems, medical devices, aerospace, etc., are incorporating more and more applications into their products. These applications must adhere to strict regulatory requirements, such as ISO 26262, Automotive SPICE, ISO 13485, ISO 14971, FDA 21 CFR Part 11, etc., to ensure product compliance with quality standards and safety. ALM systems provide a rigorous, traceable, and auditable software development process to support software development activities.

 

About Jama Connect®

Jama Software® focuses on maximizing innovation success in diverse engineering organizations. In fields such as fuel cells, electrification, aerospace, automotive software, surgical robots, and more, many clients adopt Jama Connect® ALM system to significantly reduce the risks of defects, rework, cost overruns, and recalls. By using Jama Connect®, research and engineering units can intelligently manage the development process and improve outcomes through Live Traceability™ across platforms. Jama Software® serves industries such as automotive, medical devices, life sciences, semiconductors, aerospace and defense, industrial manufacturing, consumer electronics, financial services, and insurance, with growing demand for ALM systems in these rapidly evolving sectors.

Jama Connect

Anselm Information collaborates with Teamwork.com – a leader in cloud project management solutions, enhancing collaborative efficiency in research and development.

Comprehensive Upgrade of Enterprise Collaboration Efficiency, Advancing Projects More Effectively.

 

As the complexity of business operations continues to rise, efficient project management has become an urgent challenge for enterprises. To meet this demand, Anselm Information becomes the first Solution Partner of Teamwork.com in Taiwan, offering advanced and convenient project management solutions for businesses.

 

Teamwork.com, a global leader in project collaboration solutions, is renowned for its outstanding performance and rich features in project management. With over a decade of focus on PLM solutions, Anselm Information recognizes the bottlenecks in traditional PLM systems’ project management modules and the inconvenience caused to users. Through this collaboration, Anselm Information will provide customers with a more comprehensive and professional project management solution, empowering enterprises to enhance collaboration efficiency and achieve efficient project advancement.

 

Key advantages of Teamwork.com project management solution include:

  • Comprehensive Project Management: Provides a robust project management platform, enabling teams to efficiently plan, collaborate, and execute tasks. It offers features such as task management, time tracking, and document sharing.
  • Intuitive User Interface: The platform’s user-friendly interface allows teams to easily adopt and use it. It provides a neat and organized workspace, enhancing productivity.
  • Customization: Allows users to customize according to their specific needs. Custom workflows, task lists, and templates can be created to adapt to different industries and work attributes.
  • Collaboration Tools: The platform offers various collaboration tools, including messaging, file sharing, and discussions, facilitating effective team communication and knowledge sharing.
  • Time Tracking: Includes built-in time tracking features, helping teams monitor their work hours and improve time management.
  • Reporting and Analysis: Users can access detailed reports and analyses to understand project progress and team performance.
  • Mobile Management: Provides mobile applications, ensuring teams stay connected and efficient while on the go.

 

The Teamwork.com project management platform not only meets daily project management needs for enterprises but also focuses on user experience, ensuring team members can easily get started and quickly engage in their work. Its rich features and intuitive interface make it suitable for project management across various industries and scales.

 

By choosing to be a Solution Partner of Teamwork.com, Anselm Information aims to focus on user needs and convenience during the new product development process. This partnership provides project managers and R&D departments with a comprehensive and efficient R&D collaboration solution, empowering enterprises to enhance collaboration efficiency and achieve successful product delivery, creating more value for customers.

 

If you have any questions or requirements regarding the Teamwork.com project management platform or collaboration, feel free to contact our sales team at sales@anselm.com.tw. We look forward to exploring more collaborative ways and achieving excellent enterprise management together!

Anselm Assists GOLDEN BIOTECHNOLOGY CORP. in Achieving E-documentation Management and Submission for CTD

As the complexity of drug development and market approval increases, meeting the requirements of various national pharmaceutical regulatory authorities becomes crucial. Leveraging years of experience in guiding the implementation of Oracle Agile PLM in the biotech and medical field, Anselm supports client, GOLDEN BIOTECHNOLOGY CORP., in utilizing Oracle Agile PLM along with Anselm’s developed ‘eCTD Suite’ to implement R&D document management, establish an R&D knowledge platform, and adhere to the Common Technical Document (CTD) framework developed by the International Council for Harmonisation (ICH). This assistance helps GOLDEN BIOTECHNOLOGY CORP. achieve:

 

Compliance with International Standards:

Adherence to international drug review standards such as the U.S. FDA, EU EMA, Taiwan TFDA, Japan PMDA, enhancing efficiency in submissions and obtaining drug certifications.

 

Rapid Generation of CTD Submission Documents:

Capability to generate CTD electronic submission templates based on M1~M5 sections required by different countries. The system efficiently generates CTD electronic submission document lists and data packages from Oracle Agile PLM, saving significant manual effort. Through system checks and assisted report outputs, it reduces the risk of errors, ensures the consistency and compliance of submitted documents, and maintains a complete record of the Serial Number change history.

 

Security and Compliance:

Oracle Agile PLM complies with the requirements of FDA 21 CFR Part 11, ensuring the confidentiality of sensitive data through rigorous permission controls. Additionally, we conduct system verification based on EU GAMP requirements during the implementation process, producing IQ/OQ/PQ documents. Combined with comprehensive R&D process change control, it fully meets the audit requirements of relevant regulations.

 

Real-time Collaboration:

Teams distributed across multiple global locations can achieve real-time collaboration, enhancing the speed of information flow.

 

Flexibility and Scalability:

The system can be adjusted according to client needs, providing scalability to address future technological and regulatory changes.

 

We understand the rigor and complexity of drug review processes. Through our solution, we offer a reliable, efficient, and compliant solution for the biopharmaceutical industry (new drugs, active pharmaceutical ingredients, generics), facilitating smooth regulatory approvals and rapid market entry worldwide. We look forward to providing optimal support for your business and jointly facing the challenges of the global biopharmaceutical industry.

Anselm ventures into the field of information security

Providing Forescout deployment services.

Information security is a crucial concern in today’s advancing technology landscape. However, with technological progress, ransomware attacks have also seen a surge. These hacker attacks involve encrypting users’ data and demanding payment for decryption. Such attacks can lead to severe economic losses and pose a threat to privacy. Therefore, individuals and businesses alike need to enhance their information security to safeguard against ransomware attacks.

Nevertheless, as data storage and processing increasingly migrate to the cloud, it is imperative to follow some fundamental security principles to ensure the security of cloud computing. These principles include encrypting sensitive data, implementing multiple layers of protection, and conducting regular security assessments. In this digital age, information security is paramount for cloud computing.

For businesses, taking appropriate measures to prevent data leakage, theft, corruption, or other security threats is essential. Among these, security risk detection is a vital means of safeguarding against security risks. It can help businesses proactively identify potential threats within foreseeable risks and take appropriate preventive actions when time permits. Security risk detection plays a crucial role in ensuring information security.

However, faced with a shortage of cybersecurity talent, automated control technology is becoming a powerful weapon in addressing information security issues. Through the use of automated monitoring systems, real-time monitoring of network activities is possible, enabling the rapid detection and prevention of security threats to ensure data security.

Anselm assists clients in adopting product development management solutions and understands the significance of information security for research and development data and the entire enterprise. Since 2022, Anselm has become a partner with Forescout, an automated information security solution. Forescout Technologies, Inc. provides network security automation spanning across the digital realm, aligning clients’ security architectures with their digital realities, covering all asset types: IT, IoT, operational technology, medical IoT, and cloud environments. The Forescout Continuum platform offers comprehensive asset visibility, continuous regulatory compliance, network segmentation, and a robust foundation for Zero Trust. For over 20 years, Forescout has been trusted by Fortune 100 organizations and government agencies for delivering large-scale automated network security. Forescout provides clients with data-driven intelligence, enabling the accurate detection of risks and rapid network threat remediation while ensuring uninterrupted critical business assets.

For further information, please contact: sales@anselm.com.tw

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Leading R&D Management New Trends Seminar (Taichung)

For the benefit of our loyal customers (existing Agile PLM clients) and newcomers (customers interested in PLM), Anselm, in collaboration with the U.S.-based Oracle and Yifang Technology, hosted the ‘Leading R&D Management New Trends Seminar’ on January 17, 2019, at the Sun Moon Lake Millennium Hotel in Taichung. The event aimed to enlighten attendees from the central region on how to utilize PLM for ‘Design-Manufacture Integration,’ covering the collection and analysis of market demands for product innovation, achieving greater efficiency, and fostering discussions on the application of smart manufacturing.

Below, you’ll find the agenda and highlights from the seminar

  • Implementing ‘Design-Manufacture Integration’ Innovative Management – Oracle Agile PLM Solution Blueprint.
  • When Agile PLM Meets AI and RPA – Providing R&D Teams with an Intelligent Assistant (IA).
  • Using Oracle Agile PLM to Comply with Industry Standards: IATF16949/ISO13485/AS9100, with a focus on IATF16949 as an example.
  • Small Size, Superpower – Embracing the Era with Oracle Integrated Systems.
  • Local Expertise, Professional Services – Your Best Partner in the Journey Towards Industry 4.0, ‘IVAN information’

Leading R&D Management New Trends Seminar

An increasing number of customers are inquiring about the future product roadmap of Oracle Agile PLM. What new features will it have? What new applications are in the pipeline? Does it comply with industry regulations and information security standards?

On November 2, 2018, Anselm hosted the ‘Leading R&D Management New Trends Seminar’ at the Regent Taipei, offering Oracle Agile PLM customers the opportunity to attend this experience-sharing event with a relaxed spirit.

We are grateful to the customers who participated in this event for providing us with valuable feedback. Anselm will continue to organize related seminars in the future, maintaining our commitment as a professional consulting team for Oracle Agile PLM and a bridge for knowledge exchange with the industry. Below are the agenda and highlights from the seminar:

  • Introduction to the future product roadmap and key features of Oracle Agile PLM.
  • Implementing industry standards using Oracle Agile PLM: IATF16949, ISO13485, AS9100, with a focus on IATF16949 as an example.
  • Building a secure R&D data management platform: Implementing ISO27001 standards and FDA regulations as examples.
  • Heavyweight application: When Agile PLM meets AI.

Anselm is moving again!

Anselm will be relocating on 5/28!

The new address is 6th floor, No. 46, Section 2, Zhongshan North Road, Taipei City. You can take the MRT Red Line and get off at either Zhongshan Station or Shuanglian Station, and it’s just a three-minute walk from there.

Thank you to all our partners who have been with us on this journey and supported us. Anselm has grown because of you, and it thrives because of you.

We welcome both old friends and new acquaintances to come and visit.