Focus on Your Application. We’ll Help Manage the Compliance Infrastructure.
If your software, SaaS platform, hosted application, or data solution is used by pharmaceutical, biotech, medical device, CRO, or other regulated life science organizations, your customers expect more than application performance.
They expect security, data integrity, availability, validation support, audit readiness, and compliance with 21 CFR Part 11 and other applicable regulatory requirements.
Court Square Group’s Audit Ready Compliant Cloud (ARCC) provides qualified, managed cloud infrastructure designed specifically for regulated life science applications and data.
You focus on building, supporting, and improving your solution. Court Square Group focuses on maintaining the compliant hosting environment behind it.
Make 21 CFR Part 11 Compliance Easier for Your Customers — and Your Team
Selling software into life sciences can create an additional layer of complexity.
Your customers may ask:
- Where is the application hosted?
- Is the infrastructure qualified?
- How is change controlled?
- How are backups and disaster recovery managed?
- What security controls are in place?
- Is documentation available to support validation and audits?
- How will the environment remain in a qualified state as the application changes?
ARCC helps address those infrastructure and operational requirements without forcing your software team to become experts in regulated cloud operations.
Court Square Group can provision and manage qualified environments that include infrastructure qualification, operational controls, access controls, monitoring, audit logging, backup, change control, and ongoing managed services.
Your Application. Our Compliant Hosting Foundation.
Instead of building and maintaining your own regulated hosting infrastructure, you can deploy your application within an environment designed for life science compliance.
That helps you:
- Reduce the operational burden associated with regulated hosting
- Support customer 21 CFR Part 11 requirements
- Shorten the path to deploying solutions for regulated customers
- Reduce infrastructure qualification and documentation workload
- Maintain a more consistent, controlled hosting environment
- Scale infrastructure as customers, applications, and data grow
What You Get with ARCC Hosting
A Qualified, Audit-Ready Cloud Environment
ARCC provides secure cloud hosting designed around the requirements of regulated life science organizations.
Court Square Group manages the infrastructure and the processes required to help keep the environment qualified and audit ready.
The ARCC model includes technical operations as well as quality and regulatory support. Court Square Group documentation describes ongoing management of monitoring, network configuration, storage, security, backup and recovery, qualification documentation, change management, system logs, authorization records, and other regulatory artifacts.
ARCC Hosting Can Include:
Qualified Infrastructure
Deployment of your application into an infrastructure environment designed for regulated workloads.
21 CFR Part 11 Support
Infrastructure, controls, processes, and documentation designed to support applications subject to FDA 21 CFR Part 11 requirements.
Infrastructure Qualification
IQ/OQ procedures and documentation to establish and support the qualified state of the hosting environment.
Managed Cloud Services
Day-to-day infrastructure management, monitoring, administration, patching, backup, recovery, and support.
Change Control
Controlled management of infrastructure changes with supporting documentation.
Security and Access Controls
Role-based access, security policies, audit logging, encryption, monitoring, and other technical safeguards.
Backup and Disaster Recovery
Documented backup, recovery, retention, and disaster recovery processes designed to protect regulated systems and data. The Science 37 hosting specification, for example, includes encrypted backups, geographic separation, recovery objectives, and periodic restoration testing.
Audit-Ready Documentation
SOPs, policies, work instructions, qualification documentation, system records, logs, and other artifacts to support customer audits and regulatory inspections.
Scalable Infrastructure
Resources can be expanded as application usage, customers, workloads, and data volumes grow.
Built for Technology Companies Serving Life Sciences
ARCC is not limited to pharmaceutical companies themselves. It can support technology providers whose applications or data are used within regulated life science environments, including:
- SaaS companies
- Clinical trial technology providers
- eClinical software providers
- Data and analytics platforms
- AI and machine learning applications
- Regulatory technology providers
- Pharmacovigilance platforms
- Laboratory and scientific software providers
- Quality management applications
- Document and content management systems
- Medical device software platforms
- CRO technology solutions
- Data repositories and hosted databases
- Specialized applications supporting GxP-regulated processes
Stop Building Compliance Infrastructure Around Your Software
Your core competency is your application.
Maintaining a regulated cloud environment requires an entirely different set of capabilities: infrastructure management, qualification, documentation, monitoring, security, change control, backup, disaster recovery, and quality-system processes.
Building those capabilities internally can consume technical resources that could otherwise be focused on product development and customer support.
With ARCC, Court Square Group becomes the infrastructure and compliance partner behind your application.
You Manage the Application
Your team can remain focused on:
- Product development
- Application functionality
- Customer requirements
- Product roadmap
- Application configuration
- User experience
- Application support
Court Square Group Manages the Hosting Environment
Court Square Group can support:
- Infrastructure provisioning
- Infrastructure qualification
- Cloud management
- Monitoring
- Security
- Backup and recovery
- Patch management
- Change control
- Incident management
- Qualification documentation
- Regulatory documentation
- Maintenance of the qualified state
This operating model is reflected in Court Square Group’s existing hosted-platform engagements, where Court Square Group manages the infrastructure and qualification layer while the software provider remains responsible for its application and associated configuration.
Make Your Solution Easier for Life Science Companies to Adopt
Life science buyers do not evaluate software on functionality alone.
They also need confidence that the technology can operate appropriately within a regulated environment.
Hosting your application in ARCC can help give customers a stronger answer when they ask about:
21 CFR Part 11 compliance
Demonstrate that the underlying hosting environment was designed specifically for regulated life science workloads.
Qualification
Provide documentation supporting the qualified infrastructure.
Audit readiness
Support customer vendor audits and inspection-readiness activities with controlled documentation and processes.
Security
Protect regulated applications and data with managed technical and administrative controls.
Business continuity
Support application availability with backup, recovery, monitoring, and disaster recovery processes.
Scalability
Expand the environment as customer demand and workloads increase.
Designed for Regulated Life Sciences
Court Square Group has focused on life sciences for decades and provides managed IT, validated hosting, qualification and validation, regulated content management, and other technology services for the industry.
That matters because compliant hosting is more than putting an application into the cloud.
It requires understanding how infrastructure, technology operations, quality systems, validation, security, and regulatory requirements work together.
ARCC brings those disciplines into a single managed hosting model.
Host Your Application in a Cloud Built for Life Sciences
Your customers need confidence in the technology they use. Your development team needs the freedom to keep building.
Court Square Group’s Audit Ready Compliant Cloud gives software and technology companies a qualified, managed hosting environment designed to support 21 CFR Part 11 and regulated life science requirements.
Focus on your application. Let Court Square Group help manage the infrastructure, qualification, and operational compliance behind it.
