21 CFR 11 Consulting

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.

Strategic Planning

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
  • Personnel qualifications and training
  • System design and specification
  • System development/implementation
  • Testing
  • Change control
  • Quality assurance
  • User documentation Installation and maintenance
  • Security and recoverability
  • Facilities management

A written report summarizes the assessment results and provides specific recommendations to mitigate any technical or regulatory risks discovered.

Remediation Assistance

META Solutions provides expert assistance to help clients remedy any 21 CFR Part 11 regulatory issue:

  • Validation plan development
  • Education and training
  • Documentation development
  • Vendor audits
  • Security reviews
  • SOP development
  • Test plan development and execution
  • Quality assurance
  • Development methodology review/ evaluation
  • Validation “gap” analysis

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.