• ← Back
• Computer Systems
  • Types of Computerized Systems
  • GAMP 5
  • GAMP 5 Categories
  • Validation Lifecycle (GAMP 5)
  • Specifications & Traceability
  • Qualfication of Comp. Systems
  • 21CFR Part 11 Compliance
• Process Validation
  • Process Qualification Approach
  • General Principles (FDA Guidance)
  • Establishing Acceptance Criteria
  • Process Characterization Studies
  • Data Collection Optimization
  • Statistical Process Control Tools
• Validation Approach
  • Validation Vital Role
  • Validation Steps, V-Model
  • Qualification Phases↓
    • Design Qualification
    • Installation Qualification
    • Operational Qualification
    • Performance Qualifications
    • Process Validation
  • Sequential Validation
  • Validation vs Qualification
  • Validation vs Testing
  • Protocol and Final Report
  • Validation Master Plan
  • Validation Life Cycle
  • Change Control Impact
• Regulations
  • Medical Devices↓
    • Quality System Regulation (QSR)
    • QSR vs ISO 13485
    • QMSR FDA Final Rule
  • Pharmaceutical Manufacturing
  • Biopharmaceutical Production
  • Compounding Pharmacies
  • Cosmetic Product
• Next →

Types of Computerized systems

The pharmaceutical and medical device industry relies heavily on various computerized systemsto support research, development, manufacturing, quality control, regulatory compliance, and other critical functions. Some of the major types of computerized systems utilized in this industry include:

1. Laboratory Information Management Systems (LIMS): LIMS are used to manage and track laboratory data, including sample tracking, test results, and quality control data. They help ensure data integrity and compliance with regulatory requirements.
2. Electronic Laboratory Notebooks (ELNs): ELNs are digital versions of traditional laboratory notebooks, allowing researchers to record and manage experimental data electronically. They facilitate collaboration, data sharing, and version control.
3. Data Acquisition Systems: These systems collect and record data from various instruments and equipment used in research, manufacturing, and quality control processes. They are essential for monitoring and analyzing data from analytical instruments, sensors, and laboratory equipment.
4. Building Management Systems (BMS): BMS software is used to monitor and control building infrastructure, including heating, ventilation, air conditioning (HVAC), lighting, and security systems within pharmaceutical and medical device facilities. Maintaining optimal conditions is crucial for product quality and employee safety.
5. Environmental Monitoring Systems: These systems continuously monitor environmental conditions, such as temperature, humidity, air quality, and particulate levels, in cleanrooms and manufacturing areas to ensure compliance with regulatory standards and maintain product integrity.
6. Calibration and Preventative Maintenance Management Systems: These systems are used to schedule, track, and manage the calibration and maintenance of equipment and instruments critical to manufacturing, testing, and quality control. Ensuring accurate measurements and equipment reliability is vital for compliance and product quality.
7. Validation Lifecycle Management Systems (VLMS): VLMS software helps manage the entire validation process, from protocol creation to execution and reporting. These systems often include templates for validation protocols, automated testing tools, and workflow management capabilities.
8. Test Management Tools: Test management tools, such as TestRail, Zephyr, or Microsoft Test Manager, can be used to create and manage test cases for validation protocols. These tools often integrate with issue tracking systems to manage discrepancies or issues found during testing.
9. Validation Execution Software: Some companies use specialized software for executing validation protocols. These tools may provide step-by-step guidance for testers, electronic signatures, and audit trails to ensure compliance with regulatory requirements.
10. Compliance Management Systems: These systems are designed to assist organizations in maintaining compliance with regulatory standards, including validation requirements. They can help manage validation protocols, track progress, and ensure that all necessary steps are completed.
11. Electronic Laboratory Notebooks (ELNs): ELNs can also be used to create and manage validation protocols, especially in research and development settings. They offer a collaborative platform for documenting and tracking validation activities.
12. Regulatory Compliance Software: Some compliance management software solutions, like MasterControl or Veeva Systems, provide validation protocol templates and tools for execution. They are designed to help organizations maintain compliance throughout the product lifecycle.
13. Clinical Trial Management Systems (CTMS): CTMS software helps pharmaceutical companies and research organizations plan, track, and manage clinical trials. It assists in patient recruitment, data collection, and regulatory compliance.
14. Electronic Data Capture (EDC) Systems: EDC systems are used in clinical trials to collect and manage patient data electronically. They improve data accuracy and streamline the clinical trial process.
15. Manufacturing xecution Systems (MES): MES software is used in the manufacturing of pharmaceuticals and medical devices to monitor and control production processes. It helps ensure product quality and compliance with Good Manufacturing Practices (GMP).
16. Regulatory Information Management (RIM) Systems: RIM systems assist in managing regulatory data and submissions required for product approvals and ongoing compliance. They help track and update regulatory documents and submissions.
17. Document Management Systems (DMS): DMS software is used to create, store, and manage documents related to product development, manufacturing, and regulatory compliance. It supports version control and document workflow.
18. Pharmacovigilance and Drug Safety Systems: These systems are used to collect, analyze, and report adverse events and safety data associated with pharmaceutical products. They play a crucial role in ensuring product safety.
19. Quality Management Systems (QMS): QMS software helps pharmaceutical and medical device companies manage quality control processes, audits, and compliance with quality standards such as ISO 13485 and cGMP (Current Good Manufacturing Practices).
20. Computerized Maintenance Management Systems (CMMS): CMMS software is used to manage the maintenance and calibration of equipment and instruments used in pharmaceutical manufacturing and testing. It helps ensure equipment reliability and compliance.
21. Enterprise Resource Planning (ERP) Systems: ERP systems integrate various business functions, including finance, procurement, inventory management, and supply chain management. They are used to streamline operations and improve efficiency.
22. Product Lifecycle Management (PLM) Systems: PLM systems help manage the entire lifecycle of pharmaceutical and medical device products, from concept and design to manufacturing and post-market support.