https://www.sikich.com

QMS life sciences services

Quality Management Solutions for Biotech, Pharma & Med Device companies
Our expertise

Quality Management System

Sikich provides end-to-end Quality Management System (QMS) services for life sciences, helping companies streamline compliance, boost efficiency and accelerate digital transformation, whether implementing new platforms or optimizing existing processes.
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 and 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 and 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.

agile support

Why choose Sikich for QMS?

We provide deep expertise and innovative solutions for life sciences regulatory environments, leveraging proven methodologies to ensure GxP compliance and scalable operations. Our agile support is tailored to biotech, pharma, and medical device companies, offering end-to-end QMS services from implementation to optimization. Additionally, we forge strategic partnerships with industry-leading technologies, including Honeywell, Formstack, and Plaio, to deliver robust, future-ready solutions.
CONTACT US

Ready to transform your Quality Management Strategy?

Partner with Sikich to modernize your QMS and boost results. Contact us to see how our life sciences services enhance compliance and efficiency.