Regulatory Compliance

i-Solutions provides Impact Services in the following areas of Regulatory Compliance.

Audit and Remediation. i-Solutions’ unique approach to Audit and Remediation is flexible in nature, providing one or more of the following processes: Pre-Audit Preparation, Mock Audits, GMP, GLP, GCP, 21 CFR Part 11 Audits, and Vendor Assessments and Qualifications. In a typical Audit scenario, we analyze gaps, identify the corrective actions and the responsible parties, and provide Project Management support for the delivery of a comprehensive program from a scheduling, resourcing and budgeting viewpoint. Working closely with your internal team, we are able to provide Faster Start-up, Lower Cost and Accelerated Delivery.

Quality Systems Consulting. i-Solutions can assist with the following Quality Systems challenges:

  • identifying the quality system (QSR, QSIT, ISO13485, 21st Century Initiative, FDA 21 CFR 210/211, 820) appropriate for your business;
  • comprehensive audits of existing Quality Systems;
  • identification of gaps which pose the greatest compliance risk;
  • mapping of processes to locate inefficiencies;
  • development and implementation of remediation plans; and
  • development of new Quality Systems.

Quality Management Programs. Our Compliance Proactive Advocacy Support (COMPAS) service helps clients avoid FDA actions by proactively leveraging the consent decree model without the onerous terms and conditions. The service ensures Quality is integrated with Manufacturing — not an add-on. It focuses on higher risk items, enabling the internal team to deliver the agreed upon plan with prioritization, accountability, timing and budget. The service eliminates interruption of normal supply chain activities and transforms project data into actionable Management Information. It also facilitates the company’s proactive communication of its efforts to FDA.

Validation & Qualification. i-Solutions can provide full validation services of equipment, instruments, facilities, processes and computer systems by qualified experts. These services provide Validation Master Plans, Requirements, Functional and Design Specification Development, Protocol Development, Execution, Validation Summaries and Final Reports.

Program / Project Management. The professionals of i-Solutions have over 15 years of experience dedicated to the successful management of a range of challenging activities — ranging from small projects through enormous programs — for the Life Sciences industry. Our experience of ‘On Time, On Budget, On Plan’ delivery is supported by the proven methodologies and tools that we provide, which enables Faster Start-up, Lower Costs, and Accelerated Delivery.

Benchmarking. Our knowledgeable experts understand how to identify areas of concern that are currently being focused on by agencies, and to prioritize those areas in order to focus on the most critical issues as a priority. This approach minimizes the risk to supply chain interruption.

Staffing. i-Solutions can provide specific Subject Matter Experts as well as Technical Leads for individual Client needs.

Related pages:
     •  Regulatory Database
     •  Performance Improvements and Financial Modeling
     •  COMPAS®
     •  Operations Improvement

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