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Deep Life Sciences Roots
Means Deep Domain Expertise

Right-Fit Validation Automation
Across The Life Sciences Ecosystem

Sware provides an the intelligent validation automation platform and managed services programs that flex with your business demands, from single-drug companies to medical device manufacturers to multiple therapeutic area enterprises.

res_q_software

Born out of our work within the life sciences ecosystem, Sware created a new and innovative approach to the mundane, time-consuming, and costly demands of Computer System Validation (CSV). 

Our team has decades of direct life sciences expertise and insights that helped build the most comprehensive, feature-rich SaaS-based validation platform that simplifies the most complex CSV workflows.

We partner with you to size your validation requirements and jointly define how to strategically pair our Res_Q platform and our Professional Services teams with your expertise and available resources. As a result, we can support you as you scale from validating a single system to managing multiple systems, implementations, and releases enterprise-wide.

 Biologics & Biosimilars
Infectious Disease
Rare Diseases
Orphan Drugs
Cell Therapy
Gene Therapy
First-in-Class Therapies
Medical Devices
Digital Therapeutics
DNA/RNA Therapeutics
SaMD

Power Your Business Through Pre-Built Compliance Modules

Because we come from the life sciences industry, we understand there’s no one-size-fits-all regarding the systems you use every day and how you validate them.

That’s why we’ve created pre-built compliance modules for more than 50 different systems that you can be turned on right out of the box. Fully built sets of validation documentation, templates, and automated testing thelp you implement and manage compliance more effectively and efficiently.

Because we come from the life sciences industry, we understand there’s no one-size-fits-all regarding the systems you use every day and how you validate them.

That’s why we’ve created pre-built compliance modules for more than 30 different systems that you can turn on right out of the box. Fully built sets of validation documentation, templates, and automated testing help you implement and manage compliance more effectively and efficiently.

Achieve Tailor-Made Compliance Success

We partner directly with you (and your teams) every step of the way to help you get the most out of your relationship with Sware—and more importantly to help ensure full CSV compliance.

From single product implementation, training, and support to comprehensive CSV Managed Services, you work with a dedicated Customer Success Manager who ensures you build and extract value across your validation lifecycle.

Access Expertise to Fit Your Needs

Sware’s professional services team brings deep compliance expertise which can serve as an extension of your team or function as your CSV compliance team.

We help early-stage life sciences companies define and implement their CSV validation program end-to-end and scale as they grow. Also, we help the largest of manufacturers eliminate redundancies and consolidate control of their CSV program across therapeutic areas, vendors, the enterprise, and the globe.

Comprehensive CSV Managed Services

Compliance Workflow Assessment Compliance Workflow
Assessment
 
Validation Lifecycle Framework Validation Lifecycle
Framework
 
Process & Protocol Development Process & Protocol
Development
 
Structured Risk Assessment & Strategy Structured Risk Assessment
& Strategy
 
Compliance Expert Consultation Compliance Expert
Consultation
 
Mock Audit & Audit Readiness Check Mock Audit &
Audit Readiness Check
 
Change/Release Management Change/Release
Management
 
Reporting & Analytics Reporting &
Analytics
 
Annual  Compliance Review Annual Compliance
Review
 

Put the Power of Intelligent
Automation to Work Today

Sware was built to serve the unique, complex requirements around CSV for regulated systems. Leverage our intelligent validation automation platform and our deep compliance expertise to your benefit — reach out today and schedule a no-obligation, no-pressure session with one of our team members.We’re here to help you.