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Trainings we offer
Computer System Validation, Instrument, and Process Training
Computer System Validation Training
1
Software validation is the process of ensuring that software products meet their intended requirements and specifications. It involves planning, design, testing, and documentation to identify and correct defects or errors. By following a systematic approach to software validation, developers can ensure that their products are reliable, efficient, and meet industry standards and regulations.
Instrument & Equipment Validation
2
Medical Equipment Validation is a critical process that ensures the safety, efficacy, and accuracy of medical equipment. It involves testing and verifying the equipment's performance against established standards and specifications. Validation is required for all newly acquired medical equipment and existing equipment that has undergone repairs or modifications. The benefits include compliance with regulatory agencies, improved patient outcomes, and greater confidence in the care received.
Process validation
3
Process validation is a systematic procedure that ensures a manufacturing process consistently produces quality products. It involves three stages: process design, process qualification, and continued process verification. The goal is to reduce the risk of product defects and recalls, improve quality, and minimize costs. A robust process validation methodology helps manufacturers meet regulatory requirements and customer expectations. Add a description about this item
Introduction of Computer System Validation
- What is CSV?
- What is CSA?
- Why is CSA/CSV needed?
- How do regulated companies benefit?
- How can you benefit from CSA/CSV?
CSV/CSA Deliverables
- System Assessment
- Validation Plan (VP)
- 21 CFR Part 11 Assessment
- Software Requirement Specification (SRS)
- Software Design & Development Plan (SDDP)
- Risk Assessment
- Software Design Specification (SDS)
- Code Review
- Development/Unit Testing
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Test Report
- Defect Report
- Traceability Matrix (TM)
- Validation Report (VR)
RISK MANAGEMENT
Medical device manufacturers adhere to and comply with international standards such as ISO 14971 and FDA requirements while following a systematic risk management process. The risk management process entails identifying and analyzing potential hazards associated with the device, evaluating the risks associated with each hazard, and implementing measures to mitigate the risks.
DEFECT MANAGEMENT
Defect Management is a systematic process of identifying and fixing bugs. There are various ways you can manage defects. A defect management cycle contains the following stages:
- Discovery of Defects
- Defect Categorization
- Fixing of Defect by developers
- Verification by Testers
- Defect Closure
- Defect Reports at the end of a project
Our team will teach you an effective way to manage a defect and its life cycle.
Data management
No good data, no room for improvement; that's why the industry needs to protect its data; we need to minimize the risk of data loss.
The following points will improve data integrity:
- Implement Audit trail
- Implement 21 CFR part 11: ALCOA++
- Computer System Validation in place
- Secure documents and records from any breach
- Back and Recovery
- User Training regularly
- Internal Audit regularly
Maintenance/CHANGE MANAGEMENT
Change Control is one of the first documents that should initiate the process for the software lifecycle.
- Who will be responsible?
- What is your role in change control?
- What information will go in Change Control?
- Who will close the change control?
REGULATIONS
- 21 CFR Part 820 QSR
- 21 CFR Part 11 for electronic records/ signature
- 21 CFR Part 803 Medical Device Reporting
- 21CFR Part 822 Post Market Surveillance
- 21 CFR Part 210 cGMP for manufacturing
- 21 CFR Part 211 cGMP for a finished product
Guidance/ Standards
There are many standards and guidance for a pharmaceutical company. We will teach you according to industry needs, but not limited to below standards:
- IEC 62304 - Medical Device Software - Software Life Cycle Processes
- ISO 13485 - Medical Devices - Quality Management Systems – Requirements for Regulatory Purposes
- ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices