Assuring compliance with 21 CFR Part 11 regulations requires thorough examination and evaluation across systems, products, processes, and functions within your organization. META Solutions' staff combines the industry experience of working with information systems, preclinical and clinical operations, and product development to ensure a well-rounded perspective, objectivity, and expertise to ensure your company's compliance with 21 CFR Part 11. In fact, lectures and writings of our team members helped define industry standards for 21 CFR Part 11 compliance, electronic regulatory submissions, and computer systems validation.
META Solutions helps companies develop strategic plans for complying with 21 CFR Part 11 by:
Assessing Regulatory Compliance Status
META Solutions' regulatory assessments help clients identify specific areas of risk regarding 21 CFR Part 11 compliance. Our assessments include reviewing applicable documentation, interviewing key quality assurance, support and management personnel, and addressing the following subject areas:
A written report summarizes the assessment results and provides specific recommendations to mitigate any technical or regulatory risks discovered.
META Solutions provides expert assistance to help clients remedy any 21 CFR Part 11 regulatory issue:
META Solutions applies its expertise in a practical and logical way to help companies worldwide. We continually strive for innovation and we share our principles and practices through training, presenting, and publishing. We develop services and creative offerings that provide new and more efficient ways for our customers and their vendors, suppliers, and service providers to conduct their business both within regulatory compliance and with reduced risk. We are prepared to achieve the same results for you.
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META Solutions, Inc.