Raland Technologies
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We work with you to ensure you're getting the best performance from your computer-based systems operation resources while meeting industry regulations.

Computer System Validation

Meeting the guidelines set forth by the Code of Federal Regulations Section 21, Part 11 (21 CFR Part 11) and EU GMP Annex 11 for electronic documents and signatures are critical to your credibility. Raland Technologies understands global requirements and industry regulations. We work to ensure you meet and exceed them.

We’ve developed an innovative program called PAR (Planning/Action/Results) to help our clients maneuver through – and meet – regulatory requirements. Using a Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis, we’ll develop a customized plan for your business to determine accurate, actionable, and achievable steps that yield results.

Planning – SWOT analysis of 21 CFR Part 11 Compliance

  • Limiting system access to authorized individuals
  • Use of operational system checks
  • Use of authority checks
  • Use of device checks
  • Determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
  • Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
  • Appropriate controls over systems documentation
  • Controls for open systems corresponding to controls for closed systems bulleted above
  • Requirements related to electronic signatures

Action - Technical Process to Achieving Results

  • 21CFR Part 11 Assessments and Remediation Planning
  • Regulatory Compliance Reviews
  • Vendor Audits
  • Validation Plans
  • System Acceptance Tests
  • Qualification Protocols
  • Project Management
  • Development of SOPs
  • Training
  • IT/IS Audits
  • Software Development
  • System Design Specifications
  • System Security Consulting

Results - Fully Functional Systems Developed, Implemented and Validated

  • Enterprise Resource Planning (ERP) - SAP, Oracle, JD Edwards
  • Programmable Logic Controllers (PLCs)
  • Supervisory Control and Data Acquisition (SCADA)
  • Building Management/Automation System (BMS/BAS)
  • Process Automation/Control Systems (PAS/PCS)
  • Laboratory Information Management Systems (LIMS)
  • Material and Resources Planning (MRPII)
  • Preventive Maintenance Management Systems
  • Calibration Management Systems
  • Laboratory Data Acquisition
  • Warehouse Automation Systems