Clinical Quality

Quality Management System

A Quality Management System (QMS) is a structured framework of policies and processes that ensures the consistent delivery of high-quality services and products in compliance with industry standards and regulatory requirements.

GCPre Consulting can help you with the design, implementation, and continuous improvement of your organization’s QMS. We offer expert guidance on best practices, and can support you in the implementation of an electronic Quality Management System (eQMS), which streamlines the management of the quality system through digital solutions.

Elements of the QMS

Pocesses / SOPs

Deviation Management

Training

Audits / Inspections

Issue and CAPA Management

Supplier Management

Technology QA

Risk Management

Change Management

Management Review

Knowledge Management

Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) are the documented instructions and guidelines that detail the processes within your organization. They are a critical component of your Quality Management System (QMS), and their function is to ensure compliance, efficiency and consistency across all operations.

Our SOP consultancy services are designed to support you by providing expert guidance in SOP writing and process optimization. We can review your clinical processes to identify gaps, redundancies and areas of improvement. Our expertise in SOP management ensures that your clinical procedures are robust, compliant, and streamlined.

SOPs Lifecycle

Risk Management

Integrating risk management into quality management activities has increasingly become an expectation from regulators and ICH-GCP requires Sponsors to implement risk-based approaches into their quality management system.

Our risk management consultancy services are designed to help you proactively manage clinical risks. We work closely with you to conduct thorough risk assessments, develop the optimal risk management strategy, and implement effective mitigation plans.

Risk control strategies

Accept

Acknowledging and accepting the risk when it is unlikely to occur, the impact is minimal or when the efforts outweight the benefits

Transfer

Shifting the risk to another party, e.g. by outsourcing (operational risks) or insuring (financial risks)

Avoid

Eliminating activities or processes that pose unacceptable risks removing the chance of them becoming an issue

Mitigate

Implementing measures to reduce the likelihood or impact of the risk

Clinical Quality

Quality Management System