OUR EXPERTISE
Sikich delivers comprehensive Quality Management System (QMS) services that help pharmaceutical, biotechnology, and medical device companies streamline compliance, improve operational efficiency, and accelerate digital transformation.
Whether you’re implementing a new QMS platform or optimizing existing processes, our life sciences specialists provide end-to-end support—from project management to system integrations and analytics.
Specialized Services
Managed QMS Services for Life Sciences
Outsource your QMS operations to Sikich and gain peace of mind. Our managed services include system administration, performance monitoring, and ongoing support—ensuring your quality processes stay compliant, secure, and efficient.
Life Sciences PMO (Project Management Office)
Our dedicated PMO team brings structure and agility to your QMS projects. We manage timelines, resources, and risk to ensure successful delivery of quality initiatives across your organization.
QMS Implementation Services
Deploy your QMS with confidence. Sikich specializes in fast, compliant implementations tailored to life sciences workflows, regulatory requirements, and business goals.
QMS System Integrations
Connect your QMS with ERP, CRM, LIMS, and other enterprise systems. Our integration services eliminate data silos, improve traceability, and create a unified digital ecosystem for quality and compliance.
Go Live Support & QMS Testing
Ensure a smooth QMS launch with Sikich’s go live support. We provide validation testing, user training, and real-time troubleshooting to help your team hit the ground running.
QMS Business Process Optimization
Improve quality outcomes and reduce risk. Our experts analyze and redesign your QMS processes for speed, accuracy, and scalability—helping you meet FDA, EU, EMA, and ISO standards with confidence.
QMS Reporting & Analytics
Make data-driven decisions with advanced reporting and analytics. We deliver dashboards and insights that track quality metrics, compliance status, and operational performance in real time.
Validated QMS Report Generation for Salesforce (Sikich + Formstack)
Unlock advanced reporting capabilities in your Salesforce QMS with Sikich’s Formstack-validated solution—designed specifically for life sciences organizations. Whether you’re generating audit reports, FMEAs, certificates, or regulatory correspondence, our integrated offering delivers precision, compliance, and efficiency.
AI Consulting for QMS
Navigate the complexities of integrating generative AI into your QMS. Automate quality functions with trust and create a roadmap for your organization to mitigate risk, deploy ethical data integrity approaches, all while adhering to pertinent regulatory requirements.
Why Choose Sikich for Your QMS?
- Deep expertise and forward-thinking solutions for life sciences regulatory environments
- Proven methodologies for GxP compliance and scalability
- Agile support tailored to biotech, pharma, and med device companies
- End-to-end QMS services from implementation to optimization
- Strategic partnerships with industry-leading technologies (Honeywell, Formstack, Plaio)