Synov Pharma
MES software that digitizes pharmaceutical operations with ALCOA+ traceability and regulatory compliance
Automate your value-added processes without paper. Record every action, automatically generate the digital Batch Record, and comply with the most demanding regulatory frameworks. Audit-ready at all times, with no physical files.
Why choose Synov Pharma
The difference between continuing with manual operations or executing with complete digital traceability
Without Synov
- Manual documentation prone to errors and information loss
- Incomplete traceability that complicates ANMAT/FDA audits
- Manual signatures without traceability or versioning
- Impossible to measure real productivity without accurate data
- Risk of non-conformities that can halt operations
With Synov Pharma
- Zero manual documentation — Batch Record, signatures and ALCOA+ evidence generated automatically per order
- Automatic digital approvals and signatures at every stage of the value-added process
- Multi-zone cloud library — your records secure, backed up and accessible for years
- Third parties and auditors access documentation with controlled permissions, no file sharing
- Real-time analytics — validates the operation order by order, as it executes
How it transforms your value-added operation
Three pillars designed for pharmaceutical packaging, labeling and contract manufacturing
Everything recorded automatically
Your team executes the operation normally. Synov records everything in the background: timestamps, owners, photos, signatures. At the end of each order, the Batch Record already exists — audit-ready, without anyone building it manually.
Unique Digital Signature
Each record includes a unique digital signature, a complete and immutable audit trail, and documentation versioning. All documentation is automatically stored in AWS systems with the highest security.
What do these standards mean?
ALCOA+:
A data integrity principle that ensures information is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. Synov Pharma records data following these criteria.
Unique Digital Signature:
Every action in the system is digitally signed uniquely. It includes a complete audit trail and documentation versioning for each record created.
Security & Infrastructure:
All documentation is automatically stored in AWS systems. Redundant infrastructure with backup recovery from the last 5 minutes. Integration with Microsoft Active Directory for full user control.
Digital Production Cycle
Control, Production, and Documentation
Real customer results
3PL operators who have already transformed their operations with Synov Pharma
Automated Quality Control
Challenge: Manual approvals cause delays and errors. Validating printed text against samples is slow and error-prone.
Solution: HubTEC synchronizes approvals in the workflow, blocks the process if there are rejections, and uses AI to validate prints automatically.
Result:
98% compliance, zero validation errors, 70% less time on quality control.
Automatic Digital Batch Record
Challenge: Creating Batch Records manually consumes too much time, generates inconsistencies, and complicates audits.
Solution: HubTEC documents each stage automatically, integrates valid electronic signatures, and centralizes everything in a digital Batch Record.
Result:
90% less documentation time, simpler audits, zero manual errors.
Automatic Full Traceability
Challenge: Without automatic recording, it is difficult to demonstrate full traceability. Visual evidence of processes is missing.
Solution: HubTEC records timestamps, identifies responsible parties with electronic signatures, and captures photos at every stage.
Result:
Complete ALCOA+ traceability, photographic evidence of everything, ready for any audit.
Measurable Real-Time Productivity
Challenge: Without visibility into real productivity, optimization is impossible. Manual calculations are inaccurate.
Solution: HubTEC records participants, calculates productivity by service, measures cycle times, and displays everything on a dashboard.
Result:
Total operational visibility, bottlenecks identified, 25% more efficiency.
What your plant achieves with Synov Pharma
Concrete results in value-added and packaging operations
Automatic Quality Control
Quality validates itself — AI catches print errors before they advance on the line.
Unique Digital Signature with Audit Trail
Every action signed and versioned — impossible for a production record to be lost or altered.
Complete ALCOA+ Traceability
ALCOA+ evidence generated automatically at every stage — no filling out forms or taking notes.
Real-Time MES Dashboard
The plant manager sees the entire packaging operation on a dashboard, in real time.
Productivity Calculation by Service
Productivity measured in detail — by service, by operator, by packaging order.
Automatic Invoicing by Order
Pre-invoices generated automatically from value-added service routes.
Security and reliability
Robust infrastructure, unique digital signature, and ALCOA+ traceability for your operations
AWS Redundant Infrastructure
Automatic backup recovery from the last 5 minutes
Redundant infrastructure for contingencies with 99.9% guaranteed uptime
Your Active Directory, Your Control
Integration with Microsoft Active Directory for full user control
Complete security and control for your clients over user management
Audit Trail and Versioning
Every record has a complete audit trail and documentation versioning
All documentation automatically stored in AWS with the highest security
ALCOA+ Compliance
Attributable, legible, contemporaneous, original, and accurate data
36,000+ documents processed, validated, and signed in 6 months with a single client
Implementation in 5 steps
Validated process that minimizes disruptions to your operations
Requirements Analysis
We evaluate your processes and define requirements (URS/FRS) for validation.
Solution Design
We create the integration plan with your ERPs and Microsoft Active Directory.
Implementation
We deploy gradually with IQ/OQ/PQ qualification protocols.
Training
We train your team on the new ALCOA+ operational workflow.
Go-Live and Optimization
We launch into production and continuously optimize.
Data Integrity
Signed Documents
Backup Recovery
AWS Uptime
Integrates with your current technology
Connect Synov Pharma with your existing systems seamlessly
How much time does your team lose documenting manually?
Schedule a demo with a pharma specialist and leave with a concrete plan to digitize your packaging operation.
No commitment · Pharma specialist · Response within 24 hours
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