Digitizes preparation workflows for volumetric solutions and reagents, including standardization records, approval workflows, and validity tracking. Covers the complete lifecycle: preparation templates → chemical composition integrity → standardization → restandardization → usage. Automated expiry alerts and reconciliation controls ensure that only approved, valid solutions are used in analytical testing.
Core Features
Solution Preparation & Master Governance
- Master Solution creation with name, type, and required parameters
- Standardization and re standardization workflows for volumetric solutions
- Raw data capture and report generation for every solution preparation
- Tracking of solutions by name, type, preparation batch, and usage status
Usage Tracking, Validity Control & Lifecycle Traceability
- Complete usage and consumption tracking across analytical workflows
- Validity notifications issued before solution expiry
- Automated expiry alerts and reconciliation controls ensuring compliance
- Solution termination workflows with full traceability
Compliance Assurance & Analytical Reliability
- Ensures only approved, valid solutions are used in analytical testing
- Eliminates manual tracking through fully digital lifecycle governance
- Complete audit trail for all preparation, standardization, and usage activities
- Reduces risk of expired or invalid solutions entering laboratory workflows
Key Benefits
Ensures only approved, valid solutions are used in analytical testing
Eliminates manual solution preparation tracking
Complete traceability from preparation to usage
Reduces risk of using expired or invalid solutions
Business Benefits
Prevents the use of expired or invalid solutions through controlled preparation workflows and validated usage rules
Improves accuracy of solution preparation by enforcing standardized, step wise digital procedures
Streamlines solution and reagent management with automated tracking, standardized records, and centralized documentation
Ensures full traceability from preparation to analytical results, supporting compliant laboratory investigations
Optimizes reagent usage with real time consumption visibility and structured planning
Strengthens analytical reliability by ensuring only approved and valid solutions enter the testing process
100%
Prevention of Expired Solution Use
Zero
Invalid Reagent Entries in Test Records
60–70%
Reduction in Solution Preparation Admin Time
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Frequently asked questions
Pharma is committed to helping you access trusted lab and pharmacy solutions, with expert help at every step of the way.
What types of solutions are managed in softLIMS Solutions Management?
Volumetric solutions, titration reagents, buffer solutions, mobile phase preparations, standard solutions, and all other laboratory reagents and solutions used in analytical testing.
How does the module manage standardization and re-standardization of volumetric solutions?
Standardization workflows guide analysts through the standardization process with required test entries. Re standardization is triggered at defined intervals or upon validity concerns, with full audit trail.
How are solution expiry dates tracked and enforced?
Each solution is registered with a defined validity period. Automated expiry notifications are sent before expiry, and expired solutions are automatically blocked from issuance preventing use of invalid reagents.
Can solution usage and consumption be tracked to individual batches or tests?
Yes. Each solution issuance event is linked to the specific test or batch for which it was used, providing complete traceability from preparation through analytical application.
How are raw data reports for solution preparation generated?
The system generates raw data preparation reports capturing all preparation details, analyst, date, amounts, and standardization results suitable for audit review and regulatory submissions.
How does the module ensure chemical composition integrity of prepared solutions?
Preparation templates define the required chemicals, quantities, and procedures. Analysts follow structured digital workflows with mandatory entries reducing the risk of preparation errors.
What happens when an analyst tries to use an expired solution?
Expired solutions are automatically removed from the active issuance list. If an analyst attempts to use an expired solution, the system prevents selection and prompts preparation of a fresh solution.
How does the module support multiple solution types with different management requirements?
Solutions are classified by type (volumetric, reagent, buffer) with type specific workflows, preparation templates, standardization requirements, and validity parameters.
What reports does the Solutions Management module provide?
Reports include solution preparation log, standardization data, standardization usage, termination records, solution index, and consumption history available for audit and management review.
How does Solutions Management support 21 CFR Part 11 compliance?
All preparation, standardization, issuance, and termination activities are captured with electronic signatures, timestamps, and complete audit trails fully compliant with 21 CFR Part 11.
