Application Delivery Services
Our Delivery Services
We deliver complete, validated applications for regulated industries. Every engagement includes full validation documentation and Independent Quality Assurance review.
Spreadsheet Remediation
Convert uncontrolled Excel spreadsheets into validated, 21 CFR Part 11 compliant applications for Labs, Logistics, and Quality operations.
Learn MoreCustom Software Development
Build custom validated applications from scratch for specialized GxP workflows that don't fit standard ERP modules.
Learn MoreThe V-Model Validation Process
We follow the industry-standard V-Model for software validation. The left side of the V represents specification and design. The right side represents verification and testing. Each specification on the left has a corresponding test on the right.
V-Model Validation Process
Our 4-Step Process
1. Blueprint & Gap Analysis
We extract spreadsheet logic and create a User Requirements Specification. We identify gaps between current processes and regulatory requirements.
2. Automated Build & Test
We build validated applications using the ValidKeep™ platform. Our automated testing engine executes Operational Qualification tests.
3. Independent Quality Review
An Independent Quality Unit reviews all validation evidence. They verify test results, audit trails, and documentation completeness.
4. UAT & Handover
Organizations perform User Acceptance Testing (Performance Qualification). Once approved, we deliver the complete validation package and hand over the system.
The Frozen Artifact Concept
Every validated system is a "Frozen Artifact," locked code and dependencies that cannot change without formal change control.
When we deliver validated applications, we freeze the code and all dependencies at specific versions. This includes the application code, the ValidKeep™ platform version, and all third-party libraries. The frozen state is documented in the Configuration Specification.
Any changes to the frozen artifact require formal change control. We document the change, re-run affected tests, and update the validation evidence. This ensures systems remain in a validated state throughout their lifecycle.
The frozen artifact is stored in our ValidKeep™ Hub, with immutable WORM storage ensuring the evidence cannot be altered. Every change is tracked, every test result is preserved, and every signature is captured.
Automated Validation Engine
Our automated testing engine executes Operational Qualification tests without human intervention.
The automated validation engine runs a comprehensive test suite that verifies every function, every calculation, and every workflow in applications. It captures screenshots, logs all actions, and generates test reports automatically.
This automation ensures consistency, repeatability, and completeness. Every test run produces the same evidence package. Every test result is traceable to a specific requirement. Every failure is documented with screenshots and logs.
Automated validation doesn't replace human judgment. Instead, it provides the evidence that humans need to make validation decisions. The Independent Quality Unit reviews the automated validation output, but the system ensures nothing is missed.