Overview

In the life sciences industry, a Quality Management System (QMS) acts as the essential foundation for maintaining essential compliance, product quality, and patient safety-related processes and operations. 

For this, stringent regulatory standards have to be met. Enhanced operational efficiency and driving continuous improvement throughout the product lifecycle is critical.  

The QMS integrates processes like the management of deviations, changes, CAPAs, complaints and risks, as well as assists in maintaining compliance, document control, and conducting supplier and audit management to create a robust framework for delivering safe, effective, and high-quality products to market. 

Your Business Challenges

Implementing and maintaining a QMS can present significant business challenges that, if not managed properly, can result in significant cost, regulatory fines, negative impact operational and compliance functions. 

• Global Regulatory Complexity and Compliance Requirements (e.g., FDA, EMA, ICH Q10) are constantly evolving. Keeping your QMS aligned to adhere to these changes requires frequent updates, retraining, and auditing. A streamlined and routine maintenance and system review can substantially reduce process costs and prevent non-compliance risks and fines. 
• Inefficient Deviation and CAPA Management can increase the likelihood of repeat issues/infractions, regulatory penalties, and production downtime.  
• Weak Change Control Management processes can lead to compliance gaps, product quality risks, and costly rework or recalls.  
• When Risk Management activities are disconnected from the product lifecycle, it limits a company’s ability to proactively mitigate risk; leading to late-stage quality issues and higher cost of non-conformance.  
• Limited Supplier and Audit Oversight can result in higher compliance risks, substandard materials entering production, and delayed product releases. 
• Difficulty Scaling QMS with organisational growth can lead to inconsistent quality practices and lack of global standardisation. This reduces operational efficiency and increases compliance risk.  

Your Business Benefits

• We help our clients achieve operational efficiency, lower operational costs, and reduce the risk of inspection findings and resulting remediation costs. 
• With an average of 14 years of experience in the Life Science industry, our practitioners have deep specialisation in the fields of QMS, GMP-Compliance and Regulatory Affairs. 
• We work exclusively with Pharma, Life Sciences, and MedTech clients and understand the complexities of these industries. 
• We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation.   
• We work within your QMS ecosystem and customise our services to meet your specific business needs. 
• We leverage a global team of resources which gives us a high degree of flexibility in our service delivery model. 
• Our consulting capabilities and industry expertise, combined with our commercial model allows us to deliver higher quality at a lower price point than many of our competitors. 

How We Can Help

• (e)QMS Implementation 

We build, upgrade, and implement (e)QMS for Pharma, Life Science, and MedTech according to the highest industry standards. 

• Sterile Manufacturing Compliance 

We provide full implementation support of Annex 1 requirements. This includes identifying and assessing impacted areas of clean room projects and the manufacturing process. In addition, we will evaluate and recommend a mitigation roadmap to address your projects’ risks.  

• Compliance Optimisation 

We conduct assessments of our clients’ current processes, performing focused evaluations on-site. Based on the assessment results, optimisation recommendations and a future-state roadmap are designed. Our QMS team then supports the end-to-end roadmap implementation. 

• Audit Management Support 

We provide comprehensive audit support with our certified auditors; from audit planning and audit execution to creation of audit reports. Audits follow ISO 19011 standards and are tailored to our clients’ regulatory requirements.   

• Regulatory Affairs Support 

Arcondis supports you from Development to Commercialisation and beyond with Regulatory Operations, Regulatory Intelligence and Health Policy Advocacy.