The IT infrastructure forms the digital backbone of Life Sciences organizations, enabling efficient and secure operations. When it supports GxP processes, qualification becomes more than best practice—it becomes a regulatory obligation. 

Our experts bring deep technical and regulatory know-how to ensure that all infrastructure components— firewalls, servers, software platforms, etc. — are qualified, documented, and audit-ready. Need support qualifying your IT infrastructure? We offer tailored qualification procedures and a comprehensive toolkit to streamline activities. We also provide ongoing services to maintain the qualified state of your IT infrastructure over time. 

Computerized System Validation (CSV) 
In regulated industries, the performance of computerized systems must be proven—not assumed. Our CSV services ensure your systems meet regulatory expectations and function as intended, safeguarding data integrity, product quality, and patient safety. We apply a risk-based approach aligned with FDA guidance and Software Quality Assurance (SQA) best practices—covering everything from validation planning to lifecycle maintenance. 

Change Management 
Managing change is a compliance imperative. Our experts support you through every stage—from impact assessment to documentation—ensuring your system changes are controlled, documented, traceable, and compliant across all GxP domains. 

Periodic Maintenance  
We help you maintain the compliance status of your CSV systems through regular periodic reviews, including audit trail review and user access management review. These services ensure your systems remain validated, secure, and aligned with regulatory standards—minimizing risk while maintaining performance. 

Lab Equipment Qualification / Validation 
We qualify your lab instruments at the start of their lifecycle using a structured, risk-based approach. Our teams validate the associated software, manage progress via an online platform, and ensure systems meet current regulatory and quality expectations prior to operational use. 

Analytical Method Validation 
Accurate, reproducible analytical results are non-negotiable. We validate your methods to ensure they meet international regulatory standards, providing the assurance required to support safe, effective medicines. 

Calibration & Requalification 
We perform routine calibration to ensure precision and reliability. Following any major intervention, we manage partial or full requalification to confirm ongoing performance and compliance. 

Data Integrity & Periodic Maintenance 
Our experts safeguard your lab systems with audit trail reviews, access control evaluations, and integrity assessments. Our governance-driven approach ensures your lab continues to operate with full traceability and regulatory confidence. 

Master Batch Record Modeling 
We create and maintain Master Batch Records (MBRs) in Pas-X that accurately reflect the required manufacturing process information as well as regulatory requirements —integrating with systems like DeltaV and SAP. Our experts support functional and user acceptance testing in MES environments for seamless, compliant batch execution. 

MES Engineering 
Our MES engineers manage the full lifecycle of Manufacturing Execution Systems—from validation and configuration to interface support and system optimization. We ensure your production floor runs efficiently and compliantly. 

Validation Services 
We handle validation for processes, cleanrooms, sterilization, and cleaning procedures. Whether it’s confirming a process meets its specifications or validating a clean environment, we bring the expertise needed to meet global regulatory standards. 

Engineering & Optimization 
From CAPEX project delivery to production process improvements, our engineers bring a cross-disciplinary, lean-focused approach that drives operational efficiency, compliance, and growth. 

Technology Transfer & Product Support 
We ensure smooth transitions from development to full-scale manufacturing. With robust process transfer and compliance management, we help bring high-quality products to market, faster.

Quality and Compliance Support 
We help you build and operate a QMS that drives excellence, enhances compliance, and supports operational efficiency—from documentation to validation. Our experts align your system with industry regulations and best practices. 

Deviation & CAPA Management 
We support your deviation and CAPA processes across all GxP areas. From root cause analysis to the implementation of CAPAs and effectiveness checks, we ensure robust, documented, and traceable deviation and CAPA management. 

Production QA 
Our QA consultants are embedded in production to manage in-process controls, batch reviews, product release, and GMP documentation. We help you maintain a constant state of inspection readiness and product quality.

Audit and Assessment Services 
Ensuring regulatory readiness and continuous compliance is a significant challenge in the highly regulated Life Sciences industry. At Sopra Steria, we support your organization with a proven, structured approach to prepare for audits and inspections through compliance assessments and proposed remediation plans. 

Our multidisciplinary team combines senior leads with SMEs in key domains—pharma, cybersecurity, IT, engineering—bringing diverse experience and certified expertise (e.g., PRINCE2, ISO9001, ISO27001, ITIL, Lean Six Sigma). This allows us to deliver high-impact results across your Life Sciences operations. 

We apply a three-step methodology using standardized templates and detailed checklists to ensure consistency and transparency. This method is designed to systematically assess your current compliance posture (step 1), identify gaps (step 2), and implement corrective actions (step 3). 

In the remediation phase (step 3), we: 

• Define the scope and timeline of mitigation activities 
• Prioritize remediation efforts based on risk 
• Implement mitigation actions efficiently 
• Document and summarize all executed activities 

Beyond readiness for audits and inspections, we help you achieve sustained compliance, reduce operational risk, and enhance confidence in your systems and processes. We also support vendor audits and IT supplier evaluations to ensure third-party compliance aligns with your internal standards. 

With Sopra Steria, you gain more than audit support—you gain a trusted partner in continuous improvement and quality excellence. 

Business Analysis in Life Sciences
We help you identify inefficiencies and propose improvements by analyzing your business processes, systems, and data. Our BABOK-trained analysts are experts at translating findings into actionable, digital transformation innovation. 

Project Management in Life Sciences 
Our Project Managers combine technical and regulatory expertise to lead complex, cross-functional projects. With a deep understanding of the impact of GxP regulation on projects, we ensure that timelines, deliverables, and compliance requirements are managed with precision. 

Digital Transformation and AI 
AI is revolutionizing Life Sciences—from drug discovery to personalized treatment and supply chain optimization. We help you harness AI to streamline processes, enhance outcomes, and reduce risks—all while remaining compliant in regulated environments. 

Mendix Low-Code Development 
Using Mendix, we help you design, develop, and deploy scalable applications up to 80% faster. With rapid iteration, tight business-IT collaboration, and regulatory alignment, Mendix accelerates your innovation pipeline without compromising control. 

Explore how AI and low-code can future-proof your business: Discover more about our Mendix capabilities