|
The
life sciences industry needs to comply with various stringent
government regulations, regardless of countries where they operate.
Given the complexity, and ever evolving nature of regulations, it is a
daunting task for the life sciences industry to sync with the dynamic
regulations.
The key factor to be successful in business and
regulatory compliance era, life sciences and pharmaceutical companies
need to have a robust compliance framework that complies with these
requirements not only for initial implementation, but subsequent
compliance sustenance. Quality Management and Regulatory Compliance
services from KATSI Canada are designed to help our customers address
these issues and to standardize and improve the V&V and compliance
processes.
We are regulatory compliance experts, and have
extensive experience in systems & process validation life cycle
management and implementation in compliance with global regulatory
requirements, including FDA 21 CFR Part 11, FDA 21 CFR Part 820 QSR,
ISO 13485, IEC 62304, ISO 14971, and 45 CFR Part 164 (HIPAA).
We
have developed a lean, structured, mature and scalable IT Compliance
Support Framework that helps our customers meet their regulatory
schedules and budgets by utilizing a risk-based approach to compliance,
ensure any system or equipment developed/deployed are compliant with
applicable regulations and stand up to any regulatory body inspections.
We
offer whole gamut of services including strategic consultancy, and
tactical services. Our services in the quality management and
regulatory compliance area encompass:
Strategic Consulting including
- Compliance Gap analysis and Process Improvement
- Implementation of GAMP 5 & Risk based Process Model for Compliance
- Standardizing and Harmonizing Validation Processes Across Multiple Sites
- Data Privacy and Protection (US/EU)
- GxP System Inventory and Portfolio Analysis
- Development of SOPs and Process Guidelines
- Implementation of Quality Management System (FDA QSR / ISO)
- Sarbanes–Oxley and Information Technology Governance
- Root Cause Analysis & Corrective Action/Preventive Action (CAPA)
- Audits and
Assessment Services, including Quality Management System Audits / Mock
Inspections, FDA Compliance Rediness, Vendor Audits and Training
FDA 21 CFR Part 11 Compliance (Electronic Records & Signature):
- Gap Analysis and System Assessments
- Risk Analysis
- Remediation (corrective action) Planning and Transformation
Compliance to IEC 62304 (Medical Device Software Lifecycle)
HIPAA Compliance & Remediation
Computer Systems/Software Validation based on FDA regulations
- Validation Planning
- Requirements Analysis and Traceability
- Risk and Compliance Assessments
- Validation Protocol Development
- Development and Execution of Test Scenarios and Cases
- Project Management
- Compliance Monitoring, Measurement and Reporting
- SOP Creation, Review & Roll-out
- Configuration Management and Change Control
- Periodic Reviews of Validated State of Computer Systems/Software
Computer Systems Infrastructure / Network Qualification
|
