IT Quality & Compliance

Sikich IT Quality & Compliance

Solutions for regulated life sciences and QMS

Sikich IT Quality & Compliance services help life sciences clients assess and validate applications, aligning them with applicable internal and regulatory requirements.

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Sparta Systems, A Honeywell Company 2022 Partner of the Year

Our expert consultants support your digital ecosystem for regulated industries, and are leading the charge in solutions and services in order to bridge the gap to digital transformation for our clients. Learn More
As the digital landscape and regulated industries evolve in tandem, our team has a responsibility to keep innovating and adapting right alongside them. We’ve designed a new, more versatile IT Quality & Compliance service offering for our clients. Learn More
Sikich specializes in consulting solutions for claims administration organizations, and is a Preferred Systems Integrator of Insurity and their enterprise technologies. Learn More

ITQ&C Services and Capabilities include:

SAP/Oracle/Dynamics ERP Validation

Various EDMS & LMS Applications Validation

Various LIMS & EQMS Applications Validation

Lab/Instrument & MES Validation

Data Integrity Assessments (DIA)

GxP & ERES Assessments

GxP/CBT/eLearning Training & Content Development

GxP Procedure Simplification & Authoring

Data Archive, Migration, Extraction Validation

Keeping your Digital Ecosystems Compliant

Compliance as a Service (CaaS)

is a program structured to handle all aspects of your IT Quality & Compliance needs. Sikich CaaS provides clients with a one-stop-solution that mitigates resource-related risk, and can be easily customized to meet unique and specific organizational challenges. As the digital landscape and regulated industries evolve in tandem, our team has a responsibility to keep innovating and adapting right alongside them. We’ve designed a new, more versatile IT Quality & Compliance service offering for our clients.

Benefits of CaaS:

Who we serve

Our IT Quality and Compliance Services include: QMS Standard Operating Procedures (SOPs), QMS IT Controls, FDA 21 CFR Park 11 Compliance, Quality management IT Documentation, QMS/IT Quality Computer Based Training, QMS/IT Quality e-learning, training and content development, QMS/IT Risk Mitigation, QMS/IT Data Integrity, QMS/IT Data Remediation, QMS/IT Software Validation, IT Validation, IT Risk Assessment, EMDS Validation, LMS Validation, LIMS Validation, MES Validation, Lab/Instrument Validation, GXP & ERES Assessments, GXP Procedure Simplification, GXP Authoring

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