Achieving MHRA accreditation

Introduction

Symbiosis Pharmaceutical Services, based in Scotland, is a leading contract manufacturer specializing in the production of novel injectable pharmaceuticals for clinical trials. With clients across the biotechnology sector, the company needed a robust quality management system to meet stringent regulatory requirements, including obtaining an MHRA license.

The challenge

As a growing company focused on sterile pharmaceutical manufacturing, Symbiosis faced the challenge of meeting MHRA requirements to begin production. The existing quality management processes were insufficient to meet the rigorous standards set by the regulator. The need for a centralized, electronic system to manage compliance activities such as document control, auditing and corrective actions was clear.

Finding the right solution

Symbiosis chose Ideagen as the solution that could meet their compliance needs while being flexible enough to adapt to their specific business processes. The decision was driven by Ideagen’s ability to streamline documentation management, automate workflows and provide a solid framework for regulatory audits.

Implementation and impact

The Ideagen implementation at Symbiosis Pharmaceutical Services was strategically executed for seamless integration. A needs assessment identified key areas for improvement, followed by tailored configuration and training to align with their quality management requirements.

• Training enabled staff to maximize Ideagen from day one
• Tailored configuration ensured smooth integration with existing workflows
• Centralized document management improved access and control over versioning and approvals

The impact was transformative, automating processes, securing MHRA accreditation, and ensuring ongoing compliance. This allowed Symbiosis to reduce time and resources spent on quality management, enabling a focus on higher-value activities.