Pharma LIMS

Pharma LIMS is an all-in-one solution that simplifies and optimizes lab processes, ensuring better data integrity, compliance, and operational efficiency. Its automation capabilities and real-time insights help pharmaceutical companies improve quality control, reduce costs, and enhance decision-making, all while ensuring the highest regulatory standards.

Key Features of Pharma LIMS:

Sample Management

 Efficient Tracking: Pharma LIMS enables real-time tracking of samples from receipt to disposal, reducing the risk of sample loss and ensuring precise record-keeping.

Automation: The system automates data entry and sample processing, minimizing manual errors and boosting efficiency.

Batch and Lot Management: Easily track pharmaceutical batches and lots for improved traceability and quality control.

Regulatory Compliance

21 CFR Part 11 Compliance: Pharma LIMS meets FDA requirements for electronic records and signatures, providing complete audit trails for all actions.

Good Laboratory Practices (GLP) & GMP Compliance: The system adheres to global standards, ensuring that your laboratory operations align with industry regulations.

Automated Reporting: Reports are generated with minimal manual effort, ensuring compliance and accuracy during audits.

Data Integrity & Security

Centralized Data Storage: All laboratory data is securely stored in one centralized system, offering a single point of truth for faster, more accurate decision-making.

Data Security: High-level security features, including access controls and encrypted data transmission, ensure the protection of sensitive information.

Audit Trails: The system records every action taken on data, from entry to report generation, ensuring transparency and accountability.

Real-Time Data Access & Reporting

Real-Time Updates: Pharmaceutical teams can access up-to-the-minute data on sample status, test results, and laboratory metrics, supporting timely decision-making.

Customizable Reports: Create customized reports, including quality control results, trend analyses, and compliance checks tailored to your lab's needs. Integrated Quality Control (QC)

Automated QC Checks: Pharma LIMS automates quality control processes by validating results against pre-set standards, notifying users of any deviations.

Deviation Management: The system triggers alerts and facilitates corrective actions whenever test results or processes deviate from established standards. Efficient Lab Workflow

Workflow Automation: Routine tasks like sample sorting, test assignments, and report generation are automated, increasing lab throughput and reducing manual work.

Lab Instrument Integration: The system integrates seamlessly with laboratory instruments, enabling automatic data entry, reducing manual input, and ensuring accuracy.

Real-Time Scheduling: Scheduling lab tasks, resources, and instruments is made easier with real-time visibility into available capacity.

Data Analysis & Analytics

Trend Analysis: Pharma LIMS offers tools to analyze data trends, helping to identify potential issues early before they escalate.

Advanced Analytics: Built-in analytics allow labs to assess test results, evaluate product quality, and optimize processes to improve operational efficiency and reduce costs.

Scalability and Flexibility

Scalable for Growth: Whether you operate a small lab or a large-scale pharmaceutical company, Pharma LIMS is scalable to grow with your business needs.

Customizable Features: The system is adaptable to suit the unique requirements of different lab types, from R&D to quality control to clinical testing.

Cloud-Based Accessibility

Remote Access: With a cloud-based platform, laboratory data and operations can be accessed remotely, offering flexibility, especially for multi-site pharmaceutical organizations.

Data Backup and Recovery: Cloud solutions provide automatic data backups and disaster recovery, ensuring your laboratory’s data is secure and easily recoverable.

Compliance Requirements

• FDA 21 CFR Part 11
• EU GMP Annex 11
• ICH Guidelines
• USP/BP/EP Standards
• WHO GMP

Key Functionalities

• Stability study management
• Comprehensive audit trail system
• Electronic signature compliance
• Instrument calibration and maintenance tracking
• Quality control and assurance workflows
• Manage staff training and competency
• Document Management