As the nerve center of enterprise operations, a company’s IT systems must provide robust storage capacity, continuous uptime, and the ability to perform reliably for heavy amounts of user traffic. Within the life sciences industry, the demands go even further, and an IT system’s software and processes must meet compliance regulations under federal and international standards.
As a leading life sciences consultancy, Maetrics offers extensive knowledge of IT compliance requirements and the expertise to help our clients achieve compliance. For nearly three decades, our organization has been at the forefront of IT compliance. Whether company data is stored in-house or in the cloud, Maetrics can provide insight on how to adhere to the latest compliance standards.
Evolving & Comprehensive IT Compliance Services
As enterprise technology has become more sophisticated, so have compliance regulations. The cloud and software as a service (SaaS) have emerged as alternatives to traditional IT strategies, and Maetrics has remained in step with these ongoing developments.
Our approach involves working collaboratively with a client’s IT staff to identify opportunities for greater efficiencies and to ensure that compliance standards are met. Successful IT compliance depends on how well policies and procedures are integrated with the overall Quality Management System (QMS). We guide clients on designing or improving their QMS, along with writing individual components, developing a compliance plan, and reviewing the overall completeness of the QMS.
Providing Guidance on IT Strategy, Architecture, & Governance
IT is not only continually undergoing new versions and updates, but is typically subject to budget constraints and changing employee needs. Maetrics has comprehensive experience working within the quality, compliance, and regulatory disciplines supporting finance, supply chain, research and development, customer service, and other business functions.
Our consultants possess hands-on experience covering a wide range of information technology challenges:
- Strategy and policy
- Quality Management System (QMS) procedures and methods
- Validation planning and life cycle (planning and execution of IQ/OQ/PQ)
- 510(k) device software development and testing
- 21 CFR part 11 compliance
- Data migration validation
- Enterprise Resource Planning (ERP) software
- Laboratory Information Management Software (LIMS)
- Manufacturing Execution System (MES)
- Data collection/aggregation to support UDI/UDID
- Software Development Life Cycle (SDLC)/Software Development Methodology (SDM) testing/Software Development Process (IEC 62304)
From ensuring your digital infrastructure aligns with your business strategy to writing and executing test scripts, Maetrics possesses the skills and knowledge to guide IT initiatives across the life sciences industry.
Have a Question?
Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.