AI-powered batch record review, deviation flagging, and CAPA tracking that supports QC testing and QA release decisions. Built for pharma manufacturing teams drowning in documentation.
QC analysts spend hours cross-referencing hundreds of data points per batch against specs. Manual, repetitive, and one missed deviation flag can delay QA's release decision.
Every deviation requires investigation, root cause analysis, and extensive documentation. Most follow predictable patterns that AI can recognize instantly.
Corrective and Preventive Actions involve complex workflows across departments. Tracking effectiveness and closure is a full-time job.
FDA inspections require instant access to complete, organized quality records. The scramble to "get audit-ready" shouldn't exist.
Connect your batch records, SOPs, and quality data. ClearBatch learns your processes, specifications, and regulatory requirements.
AI autonomously performs QC testing by reviewing batch records against specs, flagging deviations, and cross-referencing environmental monitoring data. 24/7, no fatigue.
Generates deviation reports for QA review, recommends CAPAs based on historical patterns, and maintains audit-ready documentation. QA uses this data to make informed release decisions.
Identifies trends across batches, predicts quality issues before they happen, and continuously refines its understanding of your processes.
| Capability | Legacy QMS | ClearBatch |
|---|---|---|
| Batch Record Review | Manual, 4-8 hours per batch | Autonomous, minutes per batch |
| Deviation Detection | After the fact, human-reported | Real-time, AI-flagged |
| CAPA Generation | Templates filled manually | AI-drafted from patterns |
| Audit Readiness | Scramble before inspection | Always audit-ready |
| Trend Analysis | Quarterly, if someone has time | Continuous, predictive |
| Annual Cost | $100K–$200K+ per site | Starting at $30K per site |
Legacy QMS systems cost $100K–$200K+ per year and still require manual work. ClearBatch is AI-native, purpose-built for paper-based lab digitization, and a fraction of the cost.
Simple, predictable pricing. One price covers your entire team at a single facility — no per-user math.
$30K–$48K billed annually per site
Start with a small team and add seats as adoption grows. Ideal for multi-department rollouts and larger facilities.
3-seat minimum • Volume discounts available
Both plans include full onboarding, ongoing updates, and dedicated support.
Custom enterprise agreements available for multi-site deployments.
AI-powered batch review, deviation management, CAPA tracking
Immutable, timestamped record of every action and decision
New features, AI model improvements, regulatory updates
Onboarding, training, and ongoing technical assistance
Validation protocols, IQ/OQ/PQ templates, SOPs
ClearBatch is designed from the ground up to operate within GMP environments. We provide comprehensive validation documentation including IQ/OQ/PQ protocols, a validation master plan, and traceability matrices. Our team works directly with your Quality Unit (QC and QA) during onboarding to ensure ClearBatch meets your facility's specific validation requirements.
ClearBatch includes core Part 11 controls: electronic signatures with unique user authentication, immutable audit trails with timestamped records, role-based access controls, and system validation documentation. Our 21 CFR Part 11 compliance roadmap is available during the demo process, and we work with your compliance team to address any specific requirements for your regulatory filing strategy.
All data is encrypted at rest (AES-256) and in transit (TLS 1.3). ClearBatch runs in SOC 2-aligned infrastructure with strict access controls, regular penetration testing, and comprehensive logging. Your batch records and quality data never leave your dedicated environment, and we can accommodate on-premise or private cloud deployments for organizations with specific data residency requirements.
Onboarding typically takes 4–8 weeks depending on the complexity of your batch records and quality processes. We start with a process mapping session to understand your SOPs and specs, then configure ClearBatch to your specific workflows. A dedicated implementation manager handles data ingestion, user training, and validation support. We don't go live until your Quality Unit (QC and QA leadership) is confident.
Yes. ClearBatch is designed to complement your existing systems, not replace everything at once. We integrate with common pharma QMS platforms, LIMS, and ERP systems via API or file-based data exchange. During the demo process, we'll map your current tech stack and identify the most effective integration approach.
Legacy systems like DART, MasterControl, and Veeva QMS typically cost $100K–$200K+ per year per site, plus implementation fees that can run $50K–$150K. ClearBatch starts at $30K per site annually — a 50–70% reduction — with onboarding and support included. More importantly, ClearBatch actually reduces the manual labor those legacy systems still require.
The best QC professionals don't just follow checklists. They think critically about risk, compliance, and process. ClearBatch handles the brute force work so your team can focus on the judgment calls that actually matter.