Whenever patient safety is involved, IT systems are subject to substantial regulatory compliance and strict adherence to applicable rules and regulations. We understand the best ways to balance risk vs. delivering solutions quickly to meet the demands of your business.

We develop a right-sized approach, leveraging appropriate technology, providing key personnel, and utilizing our extensive knowledge and framework to deliver solutions quickly and in a compliant manner.

IT Quality as a Service

We offer IT Quality services in an outsourced model as a Managed Service Provider (MSP).  We deliver using a proven methodology and successful MSP model for ITQ that will enable you to commit human capital where there is greater value to your organization. We work closely with your quality organization and IT to create a service architecture that will give you greater visibility into operational needs, planning, and execution.

Discover IT Quality as a Service, an outsourced model delivered as an Managed Service Provider

Quality Manual

Every Life Science organization recognizes the importance and value of having formal quality policies and procedures in place.  Our team of ASQ certified quality experts can help you to define your own unique roadmap and to craft your policies and procedures.

See how organizations achieve quality and compliance

We offer IT Quality services in an outsourced model as a Managed Service (MSP). We deliver using a proven methodology and successful MSP model for ITQ that will enable you to commit human capital where there is greater value to your organization.

Computer Systems Validation

Life Science organizations commit to CSV at different times and in different ways during their evolution. A CSV framework must be in place to set guidelines, safeguard controls, and mitigate risks. Our team of experts can help you to define, implement, and operate a CSV framework and develop the policies and procedures that will govern validation for your organization.

Learn about the importance of effective remediation of your validation activities how to ensure compliance

Audit and Inspection Readiness

We support companies who are preparing for audits and inspections. We map current business process workflows used to manage the development, collection and curation of research documentation/outputs which supported pre-clinical research and regulatory compliance to applicable predicate rules.

Click to see if you are prepared to achieve a successful FDA visit

Quality Management Systems

We understand how to assess environments and then instill the necessary governance, which includes a Quality Manual and CSV policy, validation deliverables, program governance and project management framework, assets and accelerators to build out the turn key quality systems, and execution work instructions to ensure successful validations and implementations. We develop all documentation and processes, and perform assessments based on current industry standards. 

Read about how implementing effective Quality Management Systems will ensure quality and compliance

We are eager to help find the right solution for your needs.

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