GxP READINESS FOR SOFTWARE VENDORS
One stop shop for GxP software platforms.
Selling software into pharma, biotech and medtech companies introduces a level of scrutiny most software vendors aren’t built for. Customers ask about validation, data integrity, audit trails and quality systems, often before a deal can move forward.
Assurea becomes your compliance and validation partner, helping you speak the language of GxP.
We help you build the processes, documentation and evidence your customers expect so GxP readiness becomes a growth enabler instead of a sales blocker.
What Challenges Do We Solve?
Helping software companies overcome the barriers to entering and growing in regulated markets.
Your prospects are asking GxP questions you can't answer
Life sciences buyers increasingly ask about validation status, data integrity controls and quality processes during evaluation. Without clear answers, deals stall.
You don't have internal GxP expertise
Building this knowledge in-house takes time your team doesn't have. We provide fractional GxP, Quality and Validation expertise so you don't have to hire it.
Every customer asks for different validation documentation
Without a standardized approach, each customer request becomes a one-off project. We help you build reusable documentation and validation packages.
Your SDLC wasn't designed for regulated customers
Life sciences customers expect traceability, change control and documented testing built into your development lifecycle, not bolted on afterward.
Enterprise customers want to audit you
Supplier audits and questionnaires are common in this market. We help you prepare, respond and pass audits with confidence.
You need certifications to progress enterprise opportunities
ISO 27001, ISO 9001 and other certifications are often prerequisites for enterprise deals. We help you get audit-ready efficiently.
Why Assurea for Software Vendors?
We understand both sides of the table.
Assurea works with software vendors and with the pharmaceutical, biotech and medtech companies that buy from them. That gives us a practical view of what regulated customers actually expect — and what’s realistic for a software company to deliver.
The objective isn’t to turn your SaaS company into a pharmaceutical company. It’s to build just enough structure, documentation and evidence to satisfy your customers’ quality and compliance requirements. Think of Assurea as your fractional GxP, Quality and Validation function — scaled to your size and stage of growth.
Our Services
+GxP Readiness and IT Governance
- GxP readiness assessments
- Life sciences market-entry roadmap
- Regulatory applicability assessments
- GxP product intended-use strategy
- Customer compliance questionnaire support
+SDLC Lifecycle
- QMS design and implementation
- GxP-ready SDLC frameworks
- Software development procedures
- Requirements and traceability frameworks
- Risk management
- Testing and verification strategies
- Defect and issue management
- Change and release management
+Validation Packages
- Validation master documentation
- Vendor IQ/OQ packages
- Requirements and traceability evidence
- Testing evidence
- Release documentation
- Validation summary documentation
- Customer validation guidance
+Customer & Audit Support
- Supplier audit readiness
- Third-party audit support
- Customer validation support
- Quality Agreements
- Security and Quality questionnaire support
+Certification Readiness
- ISO 27001
- ISO 9001
- ISO 13485, where applicable
- Other relevant Quality and information-security frameworks
+GxP Sales Team Training
- Train sales teams to speak credibly about GxP, quality and compliance
- Help sales teams answer prospect and customer compliance questions
- Prepare sales teams for supplier questionnaires and audits
- GxP sales and onboarding support
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Ready to bring your software to regulated markets?
Let’s talk about what GxP readiness looks like for your product.