Custom Software Development
Custom Validated Applications
When workflows are too specialized for standard ERP modules, we build custom validated applications from the ground up.
Our custom software development service delivers complete, validated applications for specialized GxP workflows. Whether organizations need a new system for a unique process or want to build on top of existing infrastructure, we deliver finished applications with complete validation documentation.
Every custom application includes the full validation package: User Requirements Specification, Functional Specification, Configuration Specification, Installation Qualification, Operational Qualification, and Performance Qualification protocols. Independent Quality Assurance reviews every release.
Deliverables: Complete application build, full validation documentation suite, automated OQ test suite, PQ protocol templates, Traceability Matrix, and Validation Summary Report with Independent Quality Unit signature.
When to Choose Custom Development
New Processes
Organizations have new workflows or processes that don't exist in any standard system. We design and build the application from scratch with validation built in from day one.
Unique Requirements
Processes have unique requirements that can't be met by off-the-shelf solutions or spreadsheet remediation. Custom development ensures the application fits exact needs.
Integration Needs
Organizations need custom applications that integrate with multiple systems, APIs, or data sources. We build the integration layer and the application together.
The Solution: Validated Systems, Not Just Software
We build custom applications that are fully validated, 21 CFR Part 11 compliant from day one. We don't just build the app. We deliver the entire Validated State, including the evidence binder.
Our ValidKeep™ platform provides the validation framework, but what sets us apart is totality. Every deliverable, from User Requirements Specification to Performance Qualification Protocol, is included. Independent Quality Assurance reviews every release package. Organizations receive a finished system, not consulting hours.
We layer Infrastructure Qualification (Cloudflare), Supply Chain Security (SBOMs), and Automated GAMP 5 Verification to create a compliance shield that's audit-ready on Day 1.