Whether your organization is undergoing a transformation, preparing for inspections, or simply aiming to improve daily operations, comprehensive quality and compliance services can provide the support needed to achieve these goals. Quality Systems Now (QSN) offers a suite of services designed to assist you during both business transformations and Business As Usual (BAU) operations, ensuring that your processes are efficient, compliant, and meeting regulator expectations.

Strategy and Compliance Direction for Business Transformations

Business transformations involve significant changes in processes, technology, and organizational structure. They may also include introducing a new Quality Management System (QMS), particularly to meet the requirements of GMP or an ISO standard such as ISO13485, ISO17025 or ISO9001. During these transitions, maintaining compliance with regulatory standards and ensuring the quality of operations can be challenging. QSN provides strategic direction and compliance support to guide you through these changes, both for managing current business activities and helping your team take the journey with you. Our experts help identify potential compliance issues early in the transformation process and develop strategies to address them. This proactive approach minimizes disruptions and ensures a smooth transition, allowing your business to adapt while maintaining high standards.

Pre-Inspection Audits

Preparing for regulatory inspections requires thorough audits to ensure that all aspects of your operations meet the necessary standards. QSN conducts comprehensive pre-inspection audits to identify areas of non-compliance and areas for improvement before your auditor arrives to assess your company. Our detailed audit reports provide actionable recommendations or improvements, allowing you to address any issues before the official inspection. This preparation not only reduces the risk of the auditor finding deficiencies but also demonstrates your commitment to quality and regulatory adherence.

Vendor or Third-Party Audits

Working with vendors and third-party service providers introduces additional layers of complexity to your compliance efforts. Ensuring that these partners meet your quality and compliance standards is crucial. QSN performs vendor and third-party audits to assess their compliance with relevant regulations and contractual obligations. By identifying potential risks and areas of non-compliance, these audits help you make informed decisions about your partnerships, ensuring that all parties uphold the same high standards.

Vendor Assurance

Beyond conducting audits, maintaining ongoing assurance of vendor compliance is essential. QSN offers vendor assurance services to continuously complete initial vendor qualifications or help you monitor and evaluate your vendors’ performance. This might include regular reviews of their processes, quality control measures, and compliance with regulatory standards. By establishing robust vendor assurance programs, we help you mitigate risks and maintain a high level of quality throughout your supply chain.

Process or Procedural Updates

Keeping your processes and procedures up to date with the latest industry standards and regulations is vital for maintaining compliance and operational efficiency. QSN assists with the development and implementation of process or procedural updates. Our experts work closely with your team to identify outdated practices and develop new procedures that align with current best practices and regulatory requirements. This ensures that your operations remain compliant and efficient, reducing the risk of non-conformance.

Risk Assessments

Identifying and managing risks is a fundamental aspect of quality and compliance management. QSN can facilitate risk assessments with your team to evaluate potential threats to your operations or products. By proactively addressing potential issues, you can prevent disruptions, enhance operational resilience, and ensure ongoing compliance with regulatory standards.

Validation or Qualification Protocol Development

For businesses involved in manufacturing or product development, validation and qualification are critical to ensuring that processes and equipment operate as intended. QSN provides expertise in developing validation and qualification protocols alongside your team. Our services cover protocol development, so that your team can confidently complete the execution of tasks, and we can assist you with reporting and any deviations or exceptions. This ensures that your processes and equipment are fit for purpose, operate reliably and support consistent production activities.

Supporting Study Protocol Development

In research and development, study protocols are essential for ensuring that experiments, product development and clinical trials are conducted in a controlled and compliant manner. QSN offers support in developing study protocols and design and development requirements. Our team has extensive experience in product development requirements in both GxP and ISO13485.

Pre-Audit Readiness Activities

Preparing for an audit involves more than just conducting pre-inspection audits. QSN provides comprehensive pre-audit readiness activities to ensure that your organization is fully prepared to confidently meet the auditor. This includes training staff, reviewing documentation, and conducting mock audits. These activities help identify potential areas of concern and ensure that your team is ready for the audit room!

Quality System Records Out of Control

Maintaining control over quality system records is crucial for demonstrating compliance and managing quality issues. QSN offers services to help manage quality system records that are out of control, including Corrective and Preventive Actions (CAPAs), document reviews, non-conformances or deviations, complaints, and management reviews. Our experts work with you to identify root causes, implement corrective actions, and establish systems for ongoing monitoring and improvement. This ensures that your quality system records are accurate, up-to-date, and compliant with regulatory standards.

QSN’s comprehensive suite of services supports your organization in maintaining high standards of quality and compliance during all stages of your company compliance journey. Our expertise ensures that your operations remain efficient, compliant, and of the highest quality. By addressing potential issues proactively and implementing robust systems for continuous improvement, QSN helps you achieve operational excellence and regulatory compliance.