Accelerate Your Career with Sagax
Sagax is a IT consulting for pharma & biotech. We specialize in Quality & Compliance, Lab Informatics. Our experts boost efficiency, ensure compliance, and drive business growth.
What industries does Sagax specialize in?
Sagax primarily supports life sciences, including pharmaceuticals, biotech, and medical devices, helping these industries meet rigorous regulatory and operational standards.
How does Sagax engage with its customers across different project needs?
Sagax offers flexible engagement models to match each client’s requirements. Our Managed Services deliver complete project management, while Staff Augmentation integrates skilled specialists directly into your team. For customized needs, our hybrid model blends both approaches. With onsite, nearshore, and offshore deployment options, we adapt to fit your budget, timeline, and project goals.
Who can benefit most from Sagax's Managed Services model?
Our Managed Services model is ideal for companies that want to maintain strategic control while outsourcing day-to-day operations. This includes organizations with limited internal IT/validation resources, companies managing multiple parallel projects, or those seeking consistent validation deliverables across their product portfolio. We handle everything from resourcing to delivery while keeping you informed and in control.
How can I get started with Sagax’s services?
Getting started is easy! Contact us to discuss your needs, and we’ll provide tailored solutions to help you achieve compliance and operational excellence.
How can Sagax help with SOP development and enhancement?
We transform your Standard Operating Procedures from basic documents into valuable operational tools. Our team develops clear, compliant SOPs that streamline processes while meeting all regulatory requirements (FDA, EMA, ISO). We provide complete support—from creation and optimization to implementation and training—ensuring your SOPs drive both compliance and operational excellence.
Does Sagax offer audit services?
Yes, Sagax provides two types of audit services: supplier audits for our clients (covering IT, CSV, GMP, GCP, GLP, and GVP requirements) and audit readiness programs to prepare clients for regulatory agency inspections.
How does Sagax approach Computer System Assurance (CSA) differently from traditional validation?
While both CSV and CSA use risk-based approaches, CSA provides a more objective framework focused on patient safety and product quality. This allows organizations to create better-quantified risk assessments and reduce documentation overhead by minimizing detailed testing for low-risk functions.
How does Sagax support companies transitioning from CSV to CSA?
We take a customized approach based on your organization’s CSA readiness. Starting with stakeholder education about CSV vs CSA differences, we analyze your current procedures and templates to plan necessary changes. We often implement CSA through a pilot project on a low-risk system, demonstrating real benefits before full-scale adoption.
What is Sagax Validation as a Service (VaaS)?
VaaS (Validation as a Service) is an integrated offering that bundles validation services, project management, and business analysis into one fixed price package. It’s ideal for companies seeking consistency and continuity in their validation deliverables.
What is Sagax continuous SaaS validation service?
Sagax provides continuous validation services designed specifically for SaaS applications like Veeva Vault, DocuSign, MasterControl, TrackWise, and TraceLink that undergo frequent vendor updates. Our service ensures your systems maintain their validated state through these ongoing changes.
What services does Sagax offer in Lab Informatics?
We help modernize laboratory operations through strategic consulting, system implementation, and data integration. Our services include LIMS/ELN implementation, instrument integration, data analytics solutions, and lab automation. We focus on creating connected laboratories that enhance efficiency while maintaining compliance.
Can Sagax help with vendor and system selection?
Yes, our consulting team evaluates client needs to recommend optimal vendors and systems, ensuring alignment with strategic goals and regulatory standards.
What types of LIMS systems does Sagax have expertise in?
We have extensive experience with major LIMS platforms like LabWare LIMS, Thermo Fisher SampleManager, Abbott Starlims, and LabVantage, as well as specialized solutions like MatrixGemini, Biovia etc. Our team also works with ELN systems such as Waters NuGenesis and Benchling.
What is your strategy for Lab Instrument Qualification?
We start by thoroughly reviewing the validation documents provided by the equipment supplier and identifying any gaps relative to regulatory requirements and the client’s operational needs. Our team then conducts supplemental qualification activities to address those gaps, ensuring full compliance and optimal performance of your infrastructure.
Why do I need to qualify my network infrastructure?
Infrastructure Qualification ensures your IT systems and environments (networks, servers, data centers) are installed correctly, operate as intended, and meet regulatory requirements for life sciences companies. It’s fundamental to maintaining data integrity and regulatory compliance. Without proper qualification, your critical systems and data are at risk, which can lead to compliance violations, data integrity issues, and costly operational disruptions.
How does Sagax support emerging companies with IT compliance?
Sagax helps emerging companies establish foundational IT policies, cybersecurity measures, and disaster recovery plans tailored for growth and compliance with SOX, NIST, and other standards.