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Laboratory Information Management (LIMS)

Sun Pharma tracks every sample from receipt to certificate of analysis. Chain of custody, 21 CFR Part 11 compliant—no paper trail to reconstruct.

Solution Overview

Sun Pharma tracks every sample from receipt to certificate of analysis. Chain of custody, 21 CFR Part 11 compliant—no paper trail to reconstruct. This solution is part of our Productivity domain and can be deployed in 2-4 weeks using our proven tech stack.

Industries

This solution is particularly suited for:

Pharma Food & Beverage Chemical

The Need

Pharmaceutical, food and beverage, and chemical manufacturers operate under intense regulatory scrutiny where laboratory testing is not optional—it's legally mandated. Raw materials must be tested before they can be used in manufacturing. In-process materials must be verified at multiple stages to ensure quality and safety. Finished products must undergo comprehensive testing before release. Testing is expensive—a single comprehensive test panel for a pharmaceutical intermediate might cost $500-2,000 and take 24-72 hours. Managing hundreds or thousands of tests per month across multiple laboratories, material types, and product lines requires unprecedented coordination, documentation, and traceability.

The traditional approach—paper lab notebooks, printed test request forms, manual result entry, spreadsheet-based certificate of analysis (CoA) generation—creates systemic problems. A raw material arrives at the lab, a technician writes test parameters in a notebook, performs the tests, records results on paper, and transcribes the data into a spreadsheet. Days later, someone manually generates a CoA, often discovering that missing data makes the results incomplete. When regulatory agencies audit (FDA, USDA, EFSA), auditors demand complete chains of custody showing exactly who handled each sample, when it was tested, by whom, on which instruments, and how results were verified. Paper trails and reconstructed documentation fail this test. Auditors discover gaps: "Who performed this test? What was the analyst's training status on that date? Which instrument was used? How was it calibrated?" Regulatory non-conformances lead to warning letters, facility seizures, and recalls.

The compliance requirement is not theoretical. FDA 21 CFR Part 11 explicitly requires: electronic records must have unique identification, data integrity must be ensured through audit trails, records must be protected against unauthorized access or modification, and electronic signatures must be auditable. ISO 17025 (laboratory accreditation standard) requires documented chain of custody, specific roles for authorized reviewers, and complete traceability from sample receipt through result reporting. For pharmaceutical manufacturers, the MHRA Good Manufacturing Practice (GMP) guide and EMA guidance on good laboratory practice require complete documentation of testing, instrument qualification, and analyst competency.

Beyond compliance, operational problems multiply. When results show an out-of-specification condition, tracing back to find the root cause is nearly impossible. Which batch was the failing sample from? What prior samples from the same supplier passed or failed? Which other products might contain materials from the failing batch? Manual traceability makes this investigation take weeks. Rushed answers lead to incorrect recalls or, worse, missed recalls that allow defective material to reach customers. Regulatory investigations cost $200k-500k in internal resources and consulting, plus potential penalties, product recalls, and facility downtime. A single FDA warning letter can shut down a facility for months.

Quality decisions become subjective without structured workflows. Lab supervisors must manually review results, contact technicians to investigate anomalies, and decide whether results should be accepted or rejected. Without structured workflows, some supervisors are lenient while others are strict, creating inconsistency. Products that should be rejected pass through. Products that are acceptable get held because of overly conservative decisions. Pharmaceutical batch releases are delayed waiting for lab approvals, costing millions in locked working capital. Food manufacturers cannot fulfill orders because testing delays extend product hold times.

Sample integrity is another hidden problem. Samples arrive at the lab and must be stored at specified conditions: 2-8°C for biological samples, 15-25°C for chemical samples, frozen at -20°C for long-term storage. Without automated temperature monitoring and documentation, auditors cannot confirm that samples were maintained at correct conditions throughout testing. A failed test might be dismissed as invalid because sample integrity cannot be proven. Or worse, defective products are released because sample storage failures are not documented or investigated.

The financial impact is enormous. Delays in lab results delay product releases, tying up working capital and losing sales opportunities. Failed batches that could have been saved through faster root cause investigation become total write-offs. Regulatory investigations cost hundreds of thousands of dollars. Recalls can cost millions. A single pharmaceutical product recall can cost $5-50 million in direct costs (destroying product, recall logistics) plus $100-500 million in lost sales and reputation damage. Food product recalls average $10-100 million depending on scope.

The Idea

A Laboratory Information Management System (LIMS) transforms laboratory operations from manual, error-prone processes into a coordinated, fully auditable system where every sample, test, result, and decision is tracked with complete traceability and regulatory compliance. The system manages the complete laboratory workflow: sample receipt through testing through results verification through certificate of analysis generation through archival.

When a sample arrives at the laboratory, the receiving process begins with barcode assignment. The technician scans the sample container, enters or confirms the sample ID, records the arrival date/time, documents the condition of the sample (physical integrity, sealing, temperature history if applicable), and assigns the sample to a specific storage location. This creates the first entry in the chain of custody: "Sample PH-2024-0847 received 2024-11-15 14:23 UTC from supplier Acme Chemicals. Condition: intact, sealed, temperature probe reading 4°C. Stored in cold room C-2, bin 5A. Received by technician Martinez (training current: 2024-12-14)." This record is immutable and timestamped. The system automatically checks sample storage temperature using IoT sensors connected to the cold room: if temperature drifts outside specification, the system alerts supervisors and documents the excursion for the chain of custody. If an excursion occurs during testing of sample PH-2024-0847, that fact is recorded in the test data, allowing auditors to evaluate whether the excursion invalidated the results.

Test requests are submitted electronically with complete specifications: which tests to perform, acceptance criteria, priority, due date, and any special handling requirements. The system generates a test plan that assigns tests to qualified technicians (based on documented training records) and books time on required analytical instruments. For a pharmaceutical raw material that requires HPLC analysis, the system confirms that an HPLC instrument is calibrated and qualified for the analysis, assigns the analysis to a trained technician, and schedules the work. The test request includes every requirement: sample amount needed, expected runtime, acceptance criteria (e.g., "HPLC purity must be 98.5-99.5%"), and any prerequisites (e.g., "sample must be analyzed within 2 days of receipt").

During testing, the technician logs into the instrument control system using credentials that track exactly who performed the test. Results are recorded directly into the system from the instrument (for automated instruments that output digital data) or entered by the technician with digital signature confirmation (for manual testing). The system automatically compares results against acceptance criteria: "HPLC result: 98.7% purity. Acceptance criteria: 98.5-99.5%. Status: PASS." If results fall outside criteria, the system flags the result for investigation: "Result out of specification. HPLC purity 94.2%. Acceptance range 98.5-99.5%. Recommend: repeat test, investigate instrument performance, or escalate to quality management."

The system maintains detailed audit trails for every result: instrument used (serial number, calibration status), technician who performed the test (credentials, training status), date and time of test, exact test parameters used, instrument settings, and any deviations from standard procedure. For pharmaceutical testing, this creates FDA 21 CFR Part 11 compliance: "Test ID: TEST-2024-0847-001. Performed by: Martinez, J. (qualified HPLC analyst, training current through 2024-12-14). Instrument: HPLC-Alpha, serial 12345, calibrated 2024-10-15 (next calibration: 2024-01-15). Test date/time: 2024-11-15 14:56-15:04 UTC. Parameters: injection volume 50µL, flow rate 1.0 mL/min, wavelength 254nm. Results: 98.7% purity. Approved by: Smith, M. (Lab Supervisor, authorized reviewer). Approval date/time: 2024-11-15 15:23 UTC. Signature: [electronic signature token with cryptographic verification]."

When multiple tests are required before a batch can be released (common for pharma), the system tracks test completion status and blocks premature release decisions. For a pharmaceutical batch requiring HPLC analysis, impurity testing, microbial contamination testing, and water content testing, the system shows: "HPLC: PASS (15:23 UTC). Impurity test: PENDING (submitted to external lab). Microbial test: FAILED (>10 CFU/mL, repeat required). Water content: PASS (3.2%, within spec 1-5%). Batch release blocked until all tests complete and pass." This prevents incomplete data from being used for release decisions.

Certificate of Analysis (CoA) generation is fully automated. The system compiles all test results, verification approvals, and metadata into a formatted CoA document that includes: sample identification, receipt date and condition, all tests performed with results and acceptance criteria, analyst and supervisor signatures with dates, instrument details and calibration status, and applicable regulatory disclaimers. The CoA is generated in PDF format with digital signatures so customers can verify authenticity. For customers requiring specific CoA formats (some pharma customers require specific templates), the system supports customizable CoA templates. The CoA includes a QR code linking to the immutable test record in the LIMS—auditors can scan the QR code to verify the CoA matches the underlying test data.

Regulatory compliance is built in. The system automatically maintains audit trails required by FDA 21 CFR Part 11: every data entry, modification, or deletion is logged with user ID, timestamp, and change description. Electronic signatures are cryptographically verified and cannot be forged. Role-based access control ensures only authorized personnel can approve test results—a technician can record results but cannot approve them; only designated supervisors can approve. For ISO 17025 compliance, the system documents analyst qualifications and training with expiration dates, ensuring only current, qualified personnel are assigned to testing. For chain of custody, every movement of a sample is recorded: from receiving to storage, from storage to testing, through testing completion, to final archival.

When regulatory agencies audit (FDA inspection, ISO 17025 surveillance audit, customer quality audits), the LIMS provides complete electronic records. Auditors request: "Show me all tests performed on material batch RawMat-2024-Q3-001." The system retrieves complete data: "Batch RawMat-2024-Q3-001. Received 2024-07-15. Tests performed: [List of 6 tests with dates, analysts, results, approvals]. Chain of custody: received 2024-07-15, stored in cold room until 2024-07-17 12:00 when sample was transferred to testing workstation for HPLC analysis, returned to cold storage at 2024-07-17 16:30, removed again at 2024-07-18 for microbial testing..." Complete transparency.

When unexpected quality issues are discovered, the LIMS enables rapid root cause investigation. If a customer reports defective product, a quality engineer queries the system: "Show me all test results for finished products manufactured on 2024-10-15." The system retrieves all product batches manufactured that day, along with all raw material and in-process test results that went into those products. This traces the defect backward to identify which material batch caused the problem. If the defect was in a raw material batch, the system shows all suppliers providing that material type on that date, enabling immediate supplier notification and potential recall of other customer shipments. Forward traceability is equally important: "Which customers received finished product batches manufactured with raw material batch RawMat-2024-Q3-001?" The system maps the raw material through production to identify all affected finished goods, all customer shipments containing those products, and contact information for notification.

Sample retention policies are enforced automatically. Regulatory requirements often mandate that samples be retained for specific periods: pharmaceutical raw materials for 1 year after batch completion, food testing samples for 6 months, chemical products for 2 years. The system tracks sample age and generates archival/disposal alerts: "Sample PH-2024-0847 retention period expires 2025-11-15. Authorize archival to long-term storage or disposal." Archived samples are tracked with location and disposal history, maintaining complete documentation in case future questions arise.

How It Works

flowchart TD A[Sample Arrives
at Lab] --> B[Create Sample
Record with Barcode] B --> C[Verify Sample
Integrity & Condition] C --> D[Assign to Storage
Location] D --> E[Monitor Storage
Temperature] E --> F[Submit Test
Request] F --> G[Assign Tests to
Qualified Technicians] G --> H[Verify Instruments
Calibrated & Qualified] H --> I[Perform Tests
on Instruments] I --> J[Record Results
with Audit Trail] J --> K{Results Within
Acceptance
Criteria?} K -->|No| L[Flag for
Investigation] L --> M[Lab Supervisor
Review] K -->|Yes| N[Document Result
Approval] M --> O{Approve or
Reject?} O -->|Approve| N O -->|Reject:
Retest| I O -->|Reject:
Escalate| P{All Required
Tests
Complete?} N --> P P -->|No| Q[Await Additional
Tests] Q --> P P -->|Yes| R[Generate Certificate
of Analysis] R --> S[Digital Signature
by Authorized
Reviewer] S --> T[Archive Sample
per Retention Policy] T --> U[Provide CoA to
Customer] U --> V[Maintain Audit
Trail for
Regulations]

Complete LIMS workflow from sample receipt through testing, supervisor review, and approval (with explicit retry or escalation paths for failed tests), through certificate of analysis generation and archival with full FDA 21 CFR Part 11 audit trail compliance.

The Technology

All solutions run on the IoTReady Operations Traceability Platform (OTP), designed to handle millions of data points per day with sub-second querying. The platform combines an integrated OLTP + OLAP database architecture for real-time transaction processing and powerful analytics.

Deployment options include on-premise installation, deployment on your cloud (AWS, Azure, GCP), or fully managed IoTReady-hosted solutions. All deployment models include identical enterprise features.

OTP includes built-in backup and restore, AI-powered assistance for data analysis and anomaly detection, integrated business intelligence dashboards, and spreadsheet-style data exploration. Role-based access control ensures appropriate information visibility across your organization.

Frequently Asked Questions

How much does implementing a LIMS system cost and how long does it take?
Laboratory Information Management System implementation costs typically range from $50,000 to $500,000 for enterprise solutions, but modern cloud-based or self-hosted LIMS platforms can be deployed for $15,000-$100,000 for small to mid-sized laboratories. Implementation timelines vary: cloud SaaS platforms can be operational within 4-8 weeks, while on-premises systems designed for regulated industries (pharmaceutical, food and beverage) typically require 8-16 weeks for installation, configuration, instrument integration, validation, and staff training. Recurring costs average $2,000-$10,000 monthly depending on user count and feature requirements. Custom development approaches like IoTReady's model (using proven BunJS + Elysia + Drizzle architecture) can reduce implementation time to 3-4 weeks while enabling complete data ownership through Docker-based self-hosting. Smaller labs should budget $500-2,000 monthly for maintenance and support once operational.
What is FDA 21 CFR Part 11 compliance and why does it matter for LIMS?
FDA 21 CFR Part 11 is the federal regulation that governs electronic records and electronic signatures in the pharmaceutical and food industries. Specifically, it requires: immutable audit trails recording all data entries with timestamps and user identification; data integrity enforcement preventing unauthorized modifications; electronic signatures with cryptographic verification; role-based access control limiting who can approve results; and complete traceability showing who performed each test and when. LIMS systems achieve this through append-only transaction logs (impossible to modify after creation), timestamping synced to NTP servers for audit compliance, and cryptographic signature verification. Non-compliance with 21 CFR Part 11 results in FDA warning letters, facility shutdowns, and recalls. A single warning letter typically triggers $200,000-$500,000 in regulatory consulting costs, plus millions in lost production. For pharmaceutical manufacturers, compliance is legally mandatory. For food and beverage companies, compliance increasingly required by major retailers (Walmart, Costco) who demand 21 CFR Part 11-compliant supplier documentation. ISO 17025 accreditation standards explicitly reference 21 CFR Part 11 audit trail requirements.
How does LIMS improve quality control and reduce failed batches in manufacturing?
LIMS improves quality by automating test workflows and preventing human error. Specific improvements include: automated acceptance criteria checking (results flagged immediately if out-of-specification rather than discovered days later through manual review, enabling faster investigation); preventing test result approval by unqualified personnel (system enforces role-based access requiring supervisor sign-off); tracking instrument calibration status in real-time (tests cannot be recorded on out-of-calibration equipment, eliminating invalid data); documenting sample integrity conditions (temperature excursions during storage are recorded automatically via IoT sensors); and enabling rapid root cause analysis (backward traceability identifies which material batch caused defect, forward traceability identifies which customers received affected products). Quantified impact: pharmaceutical companies report 15-30% reduction in failed batches after LIMS implementation due to faster root cause investigation, better instrument maintenance visibility, and reduced operator deviation. Food and beverage companies see 20-40% reduction in microbial contamination incidents. Chemical manufacturers report 25-35% reduction in out-of-specification results through stricter enforcement of test procedures. By reducing failed batches, manufacturing cycle time decreases by 10-20% because material holds waiting for approval are shorter (test results documented immediately in system rather than transcribed from paper).
What is a Certificate of Analysis (CoA) and why is automated CoA generation critical?
A Certificate of Analysis is the official document certifying that a material has been tested and meets specification. It includes: material identification and lot number, receipt date and sample condition, all tests performed with results and acceptance criteria, analyst and supervisor signatures with approval dates, instrument details and calibration status, and regulatory disclaimers. Customers (especially pharmaceutical companies and major retailers) require CoAs before accepting material deliveries. Manual CoA generation takes 2-3 hours per batch and introduces errors: missing test results cause incomplete CoAs that customers reject, requiring production delays while the lab re-runs tests or investigators track down results from paper notebooks. Automated LIMS-generated CoAs are produced in seconds with zero omissions, formatted consistently, and digitally signed for authenticity. CoAs can include QR codes linking to immutable LIMS records—auditors scan the code to verify the CoA matches the underlying test data, preventing fraud. For manufacturers supplying 100+ different products to customers requiring CoAs, automated generation saves 10-20 hours weekly. LIMS CoA automation also enables customizable templates—different customers require different formats, which the system manages automatically rather than requiring manual reformatting.
How does LIMS prevent regulatory non-conformances and reduce audit risk?
LIMS prevents regulatory failures by building compliance into the workflow rather than trying to retrofit it afterward. Key mechanisms: immutable audit trails record every data entry with timestamp and user ID (FDA 21 CFR Part 11 requirement)—if an analyst enters an incorrect result, the mistake is logged with date/time/name, not deleted; chain of custody tracking (required by ISO 17025) documents every sample movement: received from supplier at 10:15 AM on Nov 15, moved to cold storage at 10:30 AM, removed for HPLC testing at 2:45 PM, returned to storage at 4:20 PM; instrument qualification records (IQ/OQ/PQ) are maintained centrally with calibration expiration dates, preventing use of uncalibrated equipment; analyst training records with expiration dates ensure only qualified personnel are assigned to tests; and sample retention policies are enforced automatically—when retention period expires, alerts trigger for archival or disposal, creating documented proof of proper sample handling. Regulatory agencies typically audit records going back 2-3 years. LIMS-maintained records mean auditors find complete, consistent documentation. Without LIMS, auditors find paper trails with gaps: missing technician credentials, incomplete calibration records, undocumented temperature excursions. Manufacturers report 30-50% reduction in audit non-conformances after LIMS implementation. FDA warning letters typically cite 5-15 specific non-conformances; LIMS-compliant documentation results in zero or 1-2 minor findings instead.
Can LIMS integrate with existing manufacturing and ERP systems?
Yes, modern LIMS platforms integrate with ERP systems (SAP, Oracle, NetSuite), manufacturing execution systems (MES), and quality management systems (QMS). Integration patterns include: when raw material batch receives final test approval in LIMS, status automatically updates in ERP from 'in test' to 'approved,' allowing manufacturing planning to proceed immediately rather than waiting for manual status updates (typical delay: 2-4 hours); finished product batch records automatically pull test results from LIMS into the official batch record, creating one comprehensive document required by FDA for pharmaceutical compliance; instrument data from networked analytical equipment (HPLC, mass spectrometer, balances, pH meters) flows directly into LIMS via validated interfaces, eliminating transcription errors and creating direct linkage between equipment output and LIMS records; and customer-supplied material quality data (supplier certificates) can be imported and linked to incoming material tests for traceability. These integrations require 2-4 weeks of configuration depending on complexity. For IoTReady's self-hosted model using standard APIs (REST/GraphQL), integrations can be implemented in 1-2 weeks because the customer retains complete control over data and can leverage open-source integration tools (Apache Kafka, custom Python scripts, API webhooks). Pharmaceutical manufacturers report 15-25% reduction in batch release time when LIMS integrates with ERP, because data flows automatically rather than requiring manual entry and cross-checking.

Deployment Model

Rapid Implementation

2-4 week implementation with our proven tech stack. Get up and running quickly with minimal disruption.

Your Infrastructure

Deploy on your servers with Docker containers. You own all your data with perpetual license - no vendor lock-in.

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