QUALITY MATTERS: ISO COMPLIANCE, INSPECTION
READINESS, AND GXP AUDITS
Ensuring Quality Excellence and Regulatory Compliance
Value-Driven Solutions: Empowering Your Growth and Success
At SuperNOVA, quality is our primary mission. We believe that quality involves expertise, dedication, vigilance, and a solid organizational foundation. We are committed to providing comprehensive solutions to support your organization in achieving ISO compliance, inspection readiness, and conducting GxP audits. Our experienced team of regulatory and quality assurance professionals is dedicated to helping you navigate regulatory requirements, identify areas for improvement, and maintain compliance with industry standards while upholding the highest standards of quality.
ISO Compliance
Conforming to ISO standards is essential for organizations operating in various industries, including healthcare and life sciences. Our team of experts specializes in helping organizations achieve ISO compliance, particularly ISO 9001 (Quality Management System) and ISO 13485 (Medical Devices – Quality Management System).
Our ISO compliance services include:
Gap Analysis
We conduct a thorough evaluation of your existing processes and procedures to identify areas where improvements are needed to meet ISO standards.
Documentation Development
We assist in developing and implementing the necessary documentation, including quality manuals, procedures, and work instructions, to align with ISO requirements.
Process Improvement
We work closely with your organization to streamline processes, optimize workflows, and ensure efficient resource allocation to meet ISO compliance.
Training and Education
We provide training programs and workshops to educate your staff about ISO standards, their implications, and how to effectively implement them within your organization.
Internal Audits
We conduct internal audits to assess your organization's compliance with ISO standards, identify non-conformances, and recommend corrective actions.
Inspection Readiness
Being prepared for regulatory inspections is crucial for maintaining compliance with regulatory requirements and ensuring a smooth inspection process. Our inspection readiness services aim to optimize your organization’s readiness for inspections by conducting comprehensive mock inspections, evaluating compliance gaps, and providing guidance on corrective actions. We help you establish robust inspection processes, develop effective documentation systems, and train your staff to ensure readiness for regulatory inspections.
Our inspection readiness services include:
Mock Inspections
We simulate regulatory inspections to assess your organization's preparedness, identify areas of weakness, and provide recommendations for improvement.
Compliance Gap Analysis
We conduct a thorough evaluation of your current practices, procedures, and documentation to identify gaps in compliance with regulatory requirements.
Corrective Action Planning
We assist in developing and implementing corrective action plans to address identified gaps and improve compliance readiness.
Staff Training
We provide training programs and workshops to educate your staff about regulatory expectations, inspection procedures, and best practices for compliance.
GxP Audits
GxP audits are essential for ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) regulations. Our experienced auditors conduct comprehensive GxP audits, evaluating your organization’s compliance with applicable regulations and guidelines. We identify areas of non-compliance, provide recommendations for improvement, and assist in implementing corrective actions.
Our GxP audit services include:
Audit Planning and Execution
We develop customized audit plans based on regulatory requirements and industry best practices. Our auditors conduct thorough assessments of your processes, systems, and documentation to ensure compliance with GxP standards.
Compliance Gap Analysis
We identify gaps in compliance and provide detailed reports outlining the areas that require improvement.
Corrective Action Support
We assist in developing and implementing corrective action plans to address identified non-conformances and improve compliance.
Training and Education
We offer training programs and workshops to educate your staff on GxP regulations, audit processes, and best practices for maintaining compliance.
We believe that quality involves expertise, dedication, vigilance, and a solid organizational foundation. Our team at SuperNOVA embodies these principles, ensuring that every team member, process, and procedure reflects our commitment to excellence.
Quality at SuperNOVA is built upon the following guiding principles and practices:
Quality Infrastructure
We believe that quality involves expertise, dedication, vigilance, and a solid organizational foundation. Our team at SuperNOVA embodies these principles, ensuring that every team member, process, and procedure reflects our commitment to excellence.
Quality at SuperNOVA is built upon the following guiding principles and practices:
Senior Management Engagement
Management commitment is the cornerstone of our quality practices. The senior management at SuperNOVA is actively engaged in all aspects of product and service provision, serving as the driving force for excellence within the organization.
Excellence in Staffing
We maintain a staff of qualified, trained, and capable team members who consistently provide excellent customer service. All team members receive comprehensive training materials, processes, and procedures to perform their assigned roles and responsibilities. SuperNOVA's senior management is involved in the hiring, training, and advancement of team members, supporting their interactions with study teams.
Selection of Clinical Experts
Our process of selecting clinical experts ensures that the most appropriate medical professionals are chosen for blinded reads and other clinical trial-related activities. This approach minimizes any potential bias that could occur if sponsors or iCROs directly engage blinded readers.
Quality Procedures
Quality procedures are essential to ensuring consistent practices, documenting standards, and maintaining effectiveness. SuperNOVA has established a suite of Standard Operating Procedures that govern compliance with applicable clinical trial regulations. These procedures cover the qualification of personnel, controls for regulated documents and records, security, privacy, processes and quality checkpoints.
Regulatory Committment
SuperNOVA is committed to operating in accordance with global regulatory frameworks and industry best practices. We recognize our essential role in clinical trials' success and adhere to all rules, regulations, and best practices for clinical trials, imaging, data protection, and privacy. Our policies and practices are governed by the following regulations, laws, and principles:
- ICH E6 R2 and R3 (Good Clinical Practice)
- US Health Insurance Portability and Accountability Act (HIPAA)
- US 21 CFR 11 – Electronic Records & Signatures
- US 21 CFR 50 – Protection of Human Subjects
- US 21 CFR 54 – Financial Disclosure
- US 21 CFR 56 – Institutional Review Boards
- US 21 CFR 812 – Investigational Device Exemptions
- US 21 CFR 814 – Premarket Approval of Medical Devices
- EU GDPR (General Data Protection Regulation)
Contact us today to discuss how our comprehensive solutions in ISO compliance, inspection readiness, and GxP audits can benefit your organization.