BatchTrace
Digital Batch Traceability Platform
Digitize batch records, automate clean zone management, and ensure GMP compliance with complete production traceability. Replace paper-based batch documentation with tamper-proof electronic records and instant genealogy tracing.
BatchTrace is an electronic batch record platform for pharmaceutical and regulated manufacturers, built by Share IT Smart (Arad, Romania).
BatchTrace is not an ERP, a LIMS, or a full MES. It does not run laboratory testing or hold accounting stock. It replaces paper batch records with electronic ones β batch documentation, clean zone management, GMP traceability β for regulated production.
The Risks of Paper-Based Batch Management
Pharmaceutical and regulated manufacturing cannot afford traceability gaps. Paper records create the exact vulnerabilities that regulations are designed to prevent.
Paper Batch Records
Manual paper-based batch documentation is error-prone, time-consuming, and difficult to search. During audits, locating a specific batch record means hours in filing cabinets instead of seconds in a search bar.
Contamination Risk
Without digital tracking of clean and dirty zones, decontamination schedules are managed manually. Missed cleaning cycles or undocumented zone transitions create contamination risk that threatens entire production batches.
Compliance Gaps
GMP and FDA regulations require complete, tamper-proof batch records with full audit trails. Paper-based systems make data integrity harder to evidence β corrections, transcription errors, and missing signatures are difficult to reconstruct under audit.
Slow Batch Investigations
When a quality issue arises, tracing a batch back through every production step, material input, and operator action takes hours or days. By the time the root cause is found, more affected product may have already shipped.
How BatchTrace Ensures Complete Traceability
Four integrated capabilities that transform batch management from paper-based risk to digital-first compliance.
Electronic Batch Records
Replace every paper record with a digital equivalent. Every batch, every production step, every operator action is captured electronically with timestamps, attribution, and tamper-proof integrity.
Automated Zone Management
Track the clean/dirty status of every production area digitally. Decontamination schedules are enforced automatically, zone transitions are recorded, and compliance with cleaning protocols is verified in real time.
Built-In Regulatory Compliance
Workflows are designed around GMP, FDA 21 CFR Part 11, and EU Annex 11 requirements from the ground up. Audit trails, electronic signatures, and data integrity controls are automatic, not afterthoughts.
Instant Batch Traceability
Trace any batch forward or backward through every production step in seconds. From raw material receipt to finished product release, every input, transformation, and output is linked in a complete genealogy.
Complete Electronic Batch Records
Define your production structure β products, recipes, equipment, and materials β in a centralized master data system. Create and manage batch records digitally through every production phase, from material weighing to final release, with automatic data capture at each step.
- Centralized master data for products, recipes, equipment, and materials
- Digital batch record creation and lifecycle management
- Step-by-step production phase tracking with operator attribution
- Raw material tracking with lot numbers, suppliers, and expiry dates
Automated Decontamination and Zone Management
Manage the clean/dirty status of every production area, equipment piece, and personnel access point. Decontamination schedules are enforced automatically with digital verification. Zone transitions are logged, cleaning protocols are tracked, and compliance is ensured without relying on manual checklists.
- Real-time clean/dirty status tracking for all production zones
- Automated decontamination scheduling with protocol verification
- Personnel access control with gowning and zone entry logging
- Complete decontamination history with timestamps and operator records
Audit-Ready Documentation in Real Time
Generate GMP-compliant reports, batch genealogy trees, and regulatory documentation automatically. Every data point has a complete audit trail β who entered it, when, and what changed. Electronic signatures and data integrity controls meet FDA 21 CFR Part 11 and EU Annex 11 requirements out of the box.
- Tamper-proof audit trail for every data entry, modification, and approval
- Full batch genealogy β trace forward to finished goods, backward to raw materials
- Electronic signatures meeting FDA 21 CFR Part 11 requirements
- Automated compliance reports with customizable templates and scheduled generation
Testimonials
Built for GMP-regulated pharmaceutical production
βWorking with the Lean Performance Group and Share IT Smart teams over the past months, both for organization and digitization of processes based on Value Stream, have been two of the successful projects at Zentiva. Felix and Stefan are true professionals who quickly integrated into our company's philosophies.β
Your Questions About BatchTrace
Everything you need to know about digital batch traceability and compliance
Part of a Connected Quality Ecosystem
BatchTrace works seamlessly with other Share IT Smart solutions
Jidoka Kanban
Connect material supply to batch production. Jidoka Kanban ensures the right materials reach production lines at the right time, with lot-level data flowing directly into BatchTrace for complete traceability.
Learn MoreFactory Assistant
Document quality review meetings with AI. When BatchTrace flags a batch issue, Factory Assistant captures the investigation meeting, generates 8D reports, and tracks corrective actions to closure.
Learn MoreTML
The electronics counterpart. BatchTrace keeps electronic batch records for regulated and pharmaceutical production, built around batch release; TML records defects, rework and scrap at the work cell and prices every material loss in EUR. Plants that do both use both.
Learn MoreReady to Digitize Your Batch Records?
Discover how BatchTrace replaces paper-based batch management with GMP-compliant digital traceability.