Source: http://metasol.com/21CFR11ConSvcs.htm
Timestamp: 2018-02-22 04:24:35
Document Index: 798597787

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

META Solutions - 21 CFR 11
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:
Providing regulatory requirements and applicable guidance policy training to Pre-Clinical and Clinical Research, Clinical Data Management, Regulatory Affairs, Information Services, Software Development, and Quality Assurance personnel
Identifying the specific systems that fall under the scope of 21 CFR Part 11 and evaluating the potential regulatory issues for each
Determining if existing policies and procedures are consistent with, and conducive to, developing and deploying systems that support compliance with 21 CFR Part 11
Developing a remediation plan to address regulatory issues: stratification of systems according to risk; identification of specific system issues and corrective measures; establishment of roles and responsibilities; determination of resources requirements; and creation of milestones and target dates
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:
Company organization, SOPs, policies, and guidelines
System development/implementation
User documentation Installation and maintenance
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:
Development methodology review/ evaluation
Validation "gap" analysis