Computer system Validation and Assurance Services
In a rapidly evolving regulatory landscape, ensuring your computerized systems are compliant, efficient, and inspection-ready is non-negotiable. Progress-Experts in Lifesciences provide end-to-end consulting, transitioning you from traditional, burdensome validation to a modern, risk-based assurance model that saves time, reduces costs, and strengthens your compliance posture.
Whether you’re implementing new systems, modernizing legacy platforms, or preparing for regulatory inspections, our team delivers the expertise and support you need for successful validation outcomes.
At Progress – Experts in Life Science, we are dedicated to ensuring the quality, reliability, and compliance of our clients’ critical computer systems. With our comprehensive expertise in computer system validation and assurance, we provide tailored solutions that meet the rigorous standards of the lifescience industry.
Contact us to discuss your specific validation challenges and discover how our comprehensive services can streamline your compliance efforts while reducing risk and operational costs.
Navigating the complexities of GxP System Compliances
Are you facing challenges with…
- Regulatory Scrutiny? Keeping up with evolving guidelines from the FDA, EU, and other global bodies.
- Inefficient Processes? Spending excessive time and resources on validation activities that don’t add value.
- Data Integrity Risks? Ensuring your electronic records and signatures meet stringent ALCOA+ principles.
- Legacy Systems? Validating and integrating older systems without compromising compliance.
- System Validation and Software Assurance? Understanding how to apply critical thinking and a life cycle approach to software assurance.*
Trusted Partner for your Computer System Validation
At Progress – Expert in Lifescience, we are committed to empowering our clients with the confidence and assurance they need to navigate the complex landscape of computer system validation. Partner with us and experience the difference that our expertise and dedication can make in the success of your lifescience initiatives.
Our Approach: The Future is Assurance: Our Modern, Risk-Based Approach
The industry is moving beyond traditional Computer System Validation (CSV)—a one-time, document-heavy event. We champion Computer Software Assurance (CSA), a life cycle approach focused on critical thinking, risk management, implementing data governance reliability and integrity with product and patient safety.
Our leading experts guide your transition, ensuring your validation efforts are focused where they matter most.
Learn More About CSA:
Our comprehensive CSV/CSA Services
We are your one-stop-shop for all validation and assurance needs. Our tailor-made services cover the entire system lifecycle.
We manage the entire validation lifecycle using proven methodologies like V-Model and Agile. Our expertise covers data integrity (DI risk assessments, ALCOA++++), data migration, system integration, and bringing legacy systems into compliance.
Management Leveraging ISPE 2nd edition GAMP 5 principles, we implement a true risk-based approach. We identify and mitigate risks proactively, ensuring your validation resources are allocated efficiently and effectively, protecting both your products and your patients.
Stay compliant across all major markets. We have deep expertise in global regulations and guidelines, including:
- FDA: 21 CFR Part 11 (Electronic Records/Signatures), 21 CFR Part 210/211 (GMP)
- EU: EudraLex Annex 11 (Computerised Systems), Annex 15 (Qualification & Validation)
- Generic: PIC/S, WHO, ISPE
Be prepared for any inspection. We offer quick-scan assessments and in-depth gap analyses to identify vulnerabilities in your systems, data integrity, and cybersecurity posture. We also assist in qualifying service providers to ensure your entire supply chain is secure.
From procedures and system documents to user-friendly templates, we create documentation that is clear, concise, and compliant. We support paper-based, fully electronic, and hybrid systems, aligning with your internal documentation standards to ensure seamless integration.
We provide comprehensive vendor selection services to identify the best technology solutions for your needs. Our end-to-end system implementation services ensure seamless deployment from initial planning through go-live and beyond, minimizing disruption while maximizing compliance and efficiency. Read article The Four Phases of Transitioning from Paper to Electronic – Progress
Streamline Your Validation. Ensure Compliance
Progress Expertise
Our team has hands-on experience validating a wide range of GxP systems, from the shop floor to the cloud.
- Control & Automation Systems: We have expertise in validating all types of automation systems for quality, laboratory, and manufacturing processes, such as SCADA, PLC, and other embedded systems.
- Enterprise Systems: PC-based, Server/Client architectures.
- Modern Platforms: We can properly qualify network-based and cloud-based electronic systems (SaaS, IaaS, PaaS) and applications. Our team possesses in-depth knowledge and practical experience in implementing and validating a wide range of industry-leading software solutions. We understand the unique validation challenges and requirements associated with each, including Industry-Leading Solutions and applications for QMS, MES, LIMS, LMS, BMS, WMS, Serialization, CTMS, Pharmacovigilance, EHR, ALM.
- Emerging Technology: We are at the forefront of validating systems that leverage Artificial Intelligence (AI), helping you understand the market and implement these powerful tools in a compliant manner.
Empower Your Team with Expert-Led Training
View Our upcoming Training Programs and Webinars: Progress is also going to start Life science Automation Congress Theme
Tailor-Made CSV & CSA Training:
On-site or remote training designed for your specific systems and challenges.
Educational Webinars:
Stay current with our expert-led webinars on the latest trends and regulatory updates.
Industry Insights:
Follow our experts on LinkedIn for regular posts and valuable insights.*
Let’s discuss how our risk-based CSA approach can save you time, reduce your compliance burden, and ensure you’re always inspection-ready. Are you ready to De-risk Your Systems and Accelerate Validation?