Computerised System Validation
Strengthen Data Integrity and Regulatory Compliance with The Knowlogy Expertise.
The widespread adoption of computerised systems has become an indispensable tool for managing data, streamlining processes, and ensuring regulatory compliance. However, maintaining the integrity and trustworthiness of data generated from these systems is paramount to upholding the quality and scientific rigor of research findings.
We are often called to support small organisations with limited IT support for validation of laboratory analytical instrumentation to specialist equipment such as CT, digital x-rays.
Computer system validation audits, 21CFR11 compliance reviews and complete computer system validation services.
We provide you with comprehensive reports that outline areas for improvement and actionable recommendations to strengthen your CSV practices and enhance data integrity.
GLP Audit Services
- Computerised System Development Life Cycle (SDLC) Process Audits
- Computer System Compliance (CSC) Consulting
- 21 CRF 11 Compliance Gap assessment
- Development and deployment of Computer System Validation processes tailored to your systems
- Conduct and completion of Computer System Validation
- Computer System compliance auditing
- System-specific computer system validation audits
- Data centers
- Backup and data recovery
- Business continuity and disaster recovery
- IT Security
Consultancy
Leverage our expert CSV consultants to develop tailored CSV strategies that align with your organization’s specific needs and regulatory requirements.
We will guide you through every aspect of CSV implementation, from system selection and qualification to risk assessment and validation testing.
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Training
Enhanced Compliance
Achieve and maintain regulatory compliance with computerised system validation standards to minimize the risk of audits, fines, and regulatory investigations.
Efficient System Validation
Implement efficient and effective computerised system validation processes to streamline the validation lifecycle and minimize validation costs.
Improved System Reliability
Ensure the reliable and consistent operation of computerised systems, preventing data integrity issues and ensuring patient safety.
Reduced Risks
Mitigate potential risks associated with non-compliance, such as data breaches, regulatory sanctions, and legal liabilities.
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Mentoring & Coaching
Seek guidance and support from our experienced CSV mentors and coaches to accelerate your team’s professional development and enhance their CSV expertise.
They will provide personalized feedback, tailored advice, and ongoing support, fostering a culture of continuous improvement and CSV excellence within your organization.
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Why choose The Knowlogy for Your CSV Journey?
1. Expertise: Our team of certified CSV professionals possesses extensive experience in the laboratory sciences, ensuring a deep understanding of CSV guidelines and regulatory requirements.
2. Proven Track Record: We have a proven track record of successfully supporting laboratory teams of all sizes across diverse industries.
3. Commitment to Quality: We are committed to providing exceptional quality of service, ensuring that your CSV journey is compliant, efficient, and risk-mitigated.
4. Customer-Centric Approach: We prioritize customer satisfaction and value your input throughout every phase of your CSV engagement.
