Spreadsheet Remediation Service
Our Scope: Labs, Logistics, Quality
Quality Directors, Lab Managers, and Supply Chain Directors face the same challenge: processes too complex for paper, but too niche for ERP systems. We fill that gap.
Labs
Batch Release calculations, Temperature Excursion tracking, Stability Study management. Lab spreadsheets become validated applications with complete audit trails.
Logistics
Cold Chain monitoring, Line Clearance workflows, Shipping validation. We convert logistics spreadsheets into compliant systems that integrate with Quality Management Systems.
Quality
Vendor Scorecards, CAPA tracking, Change Control workflows. Quality spreadsheets become validated applications with electronic signatures and immutable evidence.
The ERP Gap
Processes too complex for paper, but too niche for ERP systems.
ERP systems handle the big processes: manufacturing, inventory, financials. But what about the specialized workflows? Batch Release calculations that require lab data integration. Temperature Excursion workflows that need real-time alerts. Vendor Scorecards that aggregate multiple data sources.
These processes are too complex for paper-based systems, but they don't justify the cost and complexity of custom ERP modules. They exist in the gap, and that's where we operate.
We convert these gap processes into validated applications. Not enterprise software. Not consulting hours. Finished systems with complete validation documentation.
The Solution: Validated Systems, Not Just Software
We convert uncontrolled spreadsheets into fully validated, 21 CFR Part 11 compliant applications. 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.
Key Processes We Convert
Batch Release
Lab data integration, calculation workflows, release documentation.
Temperature Excursion
Real-time monitoring, deviation workflows, impact assessment.
Line Clearance
Production line validation, checklist workflows, documentation.
Vendor Scorecards
Multi-source data aggregation, scoring algorithms, reporting.
Why It Matters: Risk Remediation, Not Software Development
We position ourselves as a risk remediation partner, not a software shop. Quality Directors aren't buying an application. They're retiring a regulatory risk. Every spreadsheet we convert reduces exposure to FDA 483s and Warning Letters.
Our validation deliverables trace from Federal Law (21 CFR Part 11) down to the specific Git Commit Hash of deployed code. We maintain a Formal Validation Master Plan that auditors can review. We provide the Independent Quality Unit signature on every Validation Summary Report.
The question isn't whether spreadsheets need validation. It's whether organizations will address them before an inspector does.