Enables automated generation of compliant labels for samples across the laboratory. The module ensures consistent identification of all sample types, prevents mixups during testing and storage, and strengthens end to end traceability across laboratory operations. Designed to support GMP and regulatory requirements for controlled, tamper evident labelling within quality controlled laboratory environments.
Core Features
Centralized Label Template Creation & Version Control
- Create standardized label templates for samples, reagents & solutions
- Version controlled label formats with approval workflows
- Role based access for template modification and release
- Ensure consistency across all QC & QA labeling operations
Barcode & QR Code Based Identification
- Auto generate barcodes and QR codes for all lab materials
- Supports linear, 2D, and custom code formats
- Fast and error free scanning for sample traceability
- Seamless integration with LIMS modules and lab instruments
Controlled Printing, Issuance & Audit Trail
- Controlled label printing with user authentication
- Prevents unauthorized or duplicate label issuance
- Time stamped audit logs for every printed label
- Inspection ready labeling records aligned with GMP & ALCOA+
Key Benefits
Eliminates manual labelling errors and sample mix-ups
Ensures consistent, compliant identification across all sample types
Strengthens traceability from sample receipt through testing and archival
Reduces risk of mislabelled samples reaching quality review
Supports GMP audit readiness with complete label activity records
Saves time through automated label generation linked to sample registration
Business Benefits
Eliminates sample identification errors by automating label creation and enforcing standardized labeling rules
Improves operational efficiency through digital label generation that seamlessly links to sample registration workflows
Prevents sample mixups with unique, system generated barcodes or QR codes for every sample
Strengthens GMP compliance by replacing manual or non standard labels with fully controlled digital identifiers
Ensures complete traceability for all label creation and reprint activities across the sample lifecycle
Enhances laboratory data integrity by maintaining consistent, compliant labeling from sample receipt through testing and archival
5–15%
Avoidable OOS Root Causes Prevented
Near Zero
Risk of Sample MixUps with Barcode IDs
10–30 min
Time Saved per Sample Batch (Label Generation)
100%
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Frequently asked questions
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What sample types does the softLIMS Label Management module generate labels for?
Finished Products, Raw Materials, In Process, Packing materials, and Stability samples all with category specific, regulation aligned label formats.
How are label templates configured per sample category?
Label templates are configured per sample category and regulatory requirement, with defined fields, barcode/QR code format, font size, and layout version controlled and approval tracked.
How does the module prevent sample mix-ups during testing and storage?
Each label contains a unique barcode or QR code generated per sample, making every sample uniquely identifiable eliminating the risk of mixups during testing, storage, and review.
How is label data auto-populated from the Sample Management module?
Upon sample registration in softLIMS Sample Manager, label fields (AR number, product name, lot number, test category, analyst, date) are auto populated eliminating manual label entry and transcription errors.
How are label reprints controlled and audited?
Label reprint requires documented justification and generates an audit trail entry with user, timestamp, and reason. Role based access restricts who can authorize reprints.
How does the module support compliance with GMP labelling requirements?
Label templates are maintained with version control and approval workflows ensuring all labels meet current regulatory labelling requirements and cannot be generated from obsolete templates.
Can the module generate labels for stability samples with time-point-specific information?
Yes. Stability labels include study protocol, time point, storage condition, and pull date in addition to standard sample identification fields ensuring unambiguous identification of stability samples.
How does the electronic signature workflow apply to label approval?
Label format approval and release are captured with electronic signatures ensuring only authorized, approved label templates are in active use within the laboratory.
How does the module reduce the risk of mislabelled samples reaching QA review?
Auto populated label data, unique barcodes, and print controls within the registered workflow significantly reduce the risk of label errors vs. manual labelling or typed labels.
How does the module save time in high-volume laboratory operations?
Automated label generation linked directly to sample registration eliminates the separate step of manually creating or printing labels saving 10–30 minutes per batch of samples in large laboratories.
