Nimble Support: Arxspan Customer Support Solutions

When choosing a SaaS solution, the most critical aspects of the service are uptime and customer service response time.

Arxspan prioritizes both of these aspects of our platform at the highest level, providing excellent system uptime, rapid response to support inquiries, and near real-time resolution of most reported system issues.

What this means to our customers is that they can expect a high-availability application service with prompt customer service responses and direct access to product experts to help answer questions and resolve issues. At Arxspan, we know that service, reliability, and fast response times are a critical aspect of customer satisfaction – and our customers will tell you that is exactly what they enjoy.

Arxspan offers prompt, around the clock support for its applications. We also offer additional services on demand:

Custom Workflows

The ArxLab Notebook system is delivered with standard workflows that include full version control, electronic signatures and witnessing workflows to ensure compliance with 21 CFR Part 11. In some situations, particularly in GxP and other proprietary and SOP-driven workflows, customized workflows are required to maintain adherence to business process. Arxspan will provide services to create custom workflows for its clients, per the specifications that can be established in a client scope of work document.

Product/Platform Integrations

The ArxLab Notebook system is designed to easily accommodate form elements whose content is driven by data tables managed elsewhere in the ArxLab environment. Interface components such as drop-down lists, restricted content fields driven by data tables and features specific to scientific research, like unit of measure requirements can easily be extended to custom form fields. All fields that are based on existing database content are enabled with an auto-complete feature.

Integrate with laboratory inventory systems, compound registration systems or other enterprise databases to drive ELN form data. Databases managed using Arxspan Services are always available to drive ELN content. ArxLab ELN content linked to data in the Arxspan cloud automatically maintains referential integrity.

Arxspan can performing custom services to integrate with client legacy systems and databases via custom API development, enabling effective communication and data management across ELN, registration, assay, inventory, and LIMS applications.

Data Security

In the past few years, SaaS delivery of scientific software solutions has become an increasingly appealing model for scientific companies, research organizations, and universities. The benefits to teams of researchers are compelling – from being able to collaborate in real time, to working with the most up to date version of the product software, to enjoying the benefits of new feature rollouts that are the product of consolidated recommendations from multiple clients using the software. Furthermore, data security and integrity associated with scientific cloud services has been well demonstrated.

The Arxspan private cloud is supported by experts in developing and hosting secure, web-based scientific software application systems. Data is stored on multiple redundant systems in world class certified data centers, and all data is transmitted using 128-bit SSL encryption. Backups of your data are available on demand, and all Arxspan infrastructure is physically located in the United States. Additional capabilities such as single sign on and multifactor authentication for signing and witnessing enhance data security. This experience makes Arxspan an ideal choice for managing and storing your scientific research data.

Security/Credentialing

Arxspan and SAFE-BioPharma® – Digital Signature Compliance Made Simple

Arxspan has partnered with the SAFE-BioPharma Association, a non-profit association that created and manages the SAFE-BioPharma digital identity and digital signature standard for the global pharmaceutical, biotechnology, and healthcare industries. The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the US Food and Drug Administration and the European Medicines Agency.

Arxspan has developed a web service that facilitates integration of SAFE-BioPharma digital signatures directly into numerous ArxLab workflows, as well as other software applications. The web service, which integrates into any software including the ArxLab system, legacy electronic laboratory notebooks, and clinical data collection tools, builds upon the credentialing standards required by the global SAFE-BioPharma digital identity and signature standard, including all requirements for identity proofing, credential issuance, and credential management.

Arxspan enables SAFE-Biopharma digital compliance in two ways:

  • ArxLab Notebook incorporates digital signing certificates compliant with the SAFE-BioPharma standard, allowing personnel with SAFE-BioPharma cyber-identities to authenticate identity and apply digital signatures when using the ArxLab Notebook.
  • Arxspan offers a web service that can be integrated with any 3rd party application, thus enabling SAFE-BioPharma Mobile signatures.

The Arxspan web service allows software programmers to easily integrate both the authentication and signature processes directly into software applications using a simplified web services API. In addition, Arxspan is available to manage major aspects of the process, including critical aspects of user-credentialing and end-user support, allowing users to interface with a single vendor.

Credentials for authentication are entered into the client-side web service. A third-party service then delivers one-time passwords to the user by text, phone message, e-mail reply, or tokens in the case of mobile applications. After proper authentication, the user authorizes Arxspan to enable the digital signature on the documents for archive.

Arxspan’s capability provides the SAFE-BioPharma community with an uncomplicated and effective way to make SAFE-BioPharma digital signatures a seamless part of any existing application.

Regulatory Compliance

ArxLab Notebook is delivered with standard workflows that include full version control, electronic signatures, and witnessing workflows to ensure compliance with 21 CFR Part 11. ArxLab Notebook is 21 CFR Part 11 qualified, pending system validation on the client side, for digital signatures and for audit history of experiments. The system manages intellectual property and offers optional support for SAFE-BioPharma® digital signature compliance. Arxspan uses industry best practices to safeguard against unauthorized data access, and routinely passes audits of its production environment for security compliance. Arxspan actively ensures that the ArxLab system will consistently be online, functional, and secure for its customers.

GxP Workflows

The ArxLab Notebook system has robust capability for configuring, managing, and enforcing standard operating procedures (SOPs), including common steps like instrument calibration, sample preparation, sample analysis, approval, and generation of a certificate of analysis. What differentiates ArxLab Notebook is the ability to overlay and enforce these SOPs on top of the features that make ArxLab Notebook so easy to use, including the QuickAdd dashboard widget, email, and SMS text messaging. ArxLab combines a familiar browser-based interface, next generation connectivity tools, and the rigor of GxP workflow enforcement, giving scientists maximum ease-of-use while enforcing regulatory compliance.