The future of life sciences is digital. Are you ready to transform your operations, accelerate discoveries, and optimize your cybersecurity stance? You can do all this and more with our team of experts who know both Digital and Life Sciences like the back of their hand.
By straddling the entire digital technology stack, we’re equipped to uncover and seize every digital opportunity within your organization – including those yet to be discovered. Our end-to-end solutions don’t just solve current challenges, but also anticipate future needs, keeping you ahead in this dynamic digital age. Don’t let technology challenges slow you down. Leverage our expertise in life sciences and IT to stay ahead of the curve, ensure regulatory compliance, and unlock new opportunities for growth.
Our Life Sciences IT Consulting service offers a holistic approach to technology transformation, specially tailored for the unique needs of the biotech, pharmaceutical, and other life sciences sectors. Our team draws from their in-depth and unique industry experiences and leverages that knowledge to drive successful completion of your project. Perhaps most importantly, we approach every engagement with our “Right the first time, every time” approach.
Welcome to Arc Technologies Group – your trusted partner in transforming digital technology into a powerful tool for innovation and growth. With us, you’re not just future-ready – you’re actively shaping the future. Besides, in life sciences, the right IT strategy isn’t just about staying competitive – it’s about changing lives. Let’s start the transformation, together.
Why ATG?
Service Offerings.
Service Use Cases:
IT/OT Convergence
IT/OT convergence refers to the integration of Information Technology (IT) systems, which involve data processing, storage, and retrieval, with Operational Technology (OT) systems, which are used to monitor and control physical devices and processes. This convergence is critical in industries such as manufacturing, utilities, and healthcare, where IT systems provide data analytics, and OT systems directly influence the production lines or control critical operations. This integration aims to improve efficiency, enhance data accuracy, reduce operational costs, and foster innovation by allowing data-driven decision-making directly on the shop floor.Long term implementation in the GxP space.
Pharmaceutical manufacturing often involves the use of complex technologies to ensure regulatory compliance, such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Clinical Practice (GCP). This is where GxP comes in. However, integrating the Information Technology (IT) aspects (like data management, analytics, etc.) and Operational Technology (OT) aspects (like machine automation, quality control systems, etc.) in such environments is a complex task. A pharmaceutical company can engage a specialized consultancy that has experience in both IT and OT domains, as well as a solid understanding of GxP regulations to help implement their strategic efficiently and successfully. ATG can help you maintain and improve compliance while optimizing operations, enhancing data integrity, improving traceability, and increasing overall operational efficiency.
21 CFR Compliance
21 CFR Part 11 is a regulation set forth by the U.S. Food and Drug Administration (FDA) that provides the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records. This is particularly relevant in regulated industries such as pharmaceuticals, medical devices, biotech, and other life sciences. OT systems are directly involved in the production and management of goods and services. In the life sciences industry, these systems might include laboratory equipment, manufacturing systems, monitoring devices, and other technologies used in producing, testing, and distributing products. OT systems and the support IT infrastructure must be able to generate, collect, and store electronic records in a secure and reliable manner to comply with 21 CFR Part 11. This includes maintaining data integrity, implementing secure access controls, and providing audit trails for all actions performed on electronic records.OT Compliance at IT Efficiency and Scale
A pharmaceutical manufacturer needing to upgrade its legacy systems to comply with FDA’s 21 CFR Part 11 regulations. Our consulting teams can be engaged to assist throughout this remediation process, from creating the supporting infrastructure for 21 CFR-compliant systems to integrating you IT and OT equipment for unique user authentication through a centralized domain, in implementing compliant electronic records and signature systems, and ensuring the integrity, confidentiality, and authenticity of electronic records. ATG can handle the whole process from start to finish. System design, implementation, documentation, and validation are all within the deep capabilities of our life science consulting team.
Long Term Systems Integration
Large scale systems integration involves connecting multiple individual subsystems to operate as one unified system. This can include hardware, software, or organizational elements. The aim is seamless data flow, unified control, and standardized protocols across all components. Key aspects include interoperability (ensuring systems can communicate), data integration (enabling smooth data flow), business process integration (aligning workflows), security and compliance (ensuring regulation adherence and data security), and maintenance/support.Peace of mind through experienced teams.
An enterprise, for example, a mid-cap CRObank, might be looking to integrate its legacy systems with new technologies like cloud computing and ML. However, the task of doing so is enormous and fraught with risks. The enterprise can outsource this systems integration to an IT service provider specializing in this field. The provider can assess the existing infrastructure, recommend the right technologies, manage the integration process, and provide continuous support. This would help the enterprise to avoid operational disruption during the transition, leverage the best technologies, and reduce the risks associated with integration.
Outsourced Data Management
Outsourced data management involves delegating the tasks of collecting, storing, processing, and analyzing data to a third-party service provider. This can include database design and maintenance, data security, backup and recovery, and data analytics. It allows organizations to focus on core activities while ensuring that data is handled professionally, reducing costs, improving efficiency, and leveraging the provider's expertise for data-driven decision-making.Data is our domain - don't let it be your headache.
A biotechnology firm might be engaged in a large-scale genomic sequencing project. The vast amount of data generated from such a project requires specialized IT resources to store, process, and analyze. The firm could outsource this data management to an IT service provider with expertise in bioinformatics. The service provider could offer scalable cloud-based storage solutions, provide tools for big data analytics, and support the firm in deriving valuable insights from the genomic data. This would not only alleviate the burden of managing massive amounts of data but also accelerate the firm’s research and development efforts.
Large enough to do it right. Small enough to give a damn.
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