Syntegrate Solutions offers comprehensive consulting services in regulatory and validation compliance. Our team of experienced consultants provides expertise in quality systems and compliance, specializing in both project-based needs and staff augmentation to support your team or provide niche subject matter expertise.

Given the criticality of regulatory compliance, effective practices, quality assurance, and system validation for organizations, Syntegrate Solutions takes a comprehensive approach to ensure compliance. We understand the increasing pressure from regulatory agencies, such as the FDA and NIH, regarding system compliance with regulations like 21 CFR Part 11 and GCP. Non-compliance and the heightened oversight from regulatory bodies can lead to costly delays or even trial suspensions, impacting sponsor companies significantly.

Syntegrate Solutions excels in building teams for on-site and off-site assignments, strategically supporting compliance and validation initiatives. Whether it’s augmenting your existing team through staffing services or assembling a highly qualified team for outsourcing projects, we focus on providing the right level of talent to meet your project requirements.

Our experienced consultants within the Syntegrate Solutions Professional Services Organization possess technical expertise and project management capabilities necessary for successful implementation of our solutions. We follow the proven Syntegrate Solutions Implementation Methodology (SIM) that adheres to industry best practices, reducing implementation time, mitigating risks, and configuring solutions to meet your specific needs.

Throughout the implementation stages, our solution managers collaborate closely with client business and technical project leads to define a comprehensive plan and schedule, including resource requirements and change management processes. We proactively identify risks and develop appropriate mitigation plans.

The implementation stages overseen by the study director or account manager and executive sponsor of the project include:
  • Project Planning
  • Configuration and Development
  • Quality Assurance and Validation

The scope, complexity, and duration of each implementation vary based on individual customer requirements. Syntegrate Solutions ensures long-term success by addressing clients’ current needs while providing scalability to support future compliance initiatives.

Our comprehensive validation services include:
  • Consultation
  • Staff Augmentation
  • Computer System Validation
  • Process Validation
  • Analytical Instrument/Equipment Validation
  • Cleaning Validation
  • Enterprise Application Compliance Solutions
  • IT Infrastructure Qualification
  • Facility/Utility Commissioning and Qualification
  • Qualification Protocol Development & Execution
  • 21 CFR Part 11 Compliance for computerized systems
Additionally, we offer a range of technical services:
  • Validation Projects and/or Staffing
  • Clinical Systems Risk Assessment
  • Validation Plan and Project Management
  • Vendor Auditing
  • Risk Assessment and Mitigation Activities
  • User, Functional and System Requirements Gathering and Documentation
  • System Design Qualification Documentation (DQ, DS)
  • Qualification Protocol (IQ, OQ and PQ) Development and Execution
  • Validation Reporting and Traceability Matrices
  • SOP Development, Review and User Training
  • Gap Analysis and Remediation
  • 21 CFR Part 11 and Impact Assessments
  • Qualification Protocols and Test Script Creation & Execution
  • Quality & System Audits
  • User Training & Education Programs

Syntegrate Solutions also offers consulting services in compliance and quality systems, including regulatory gap analysis, program development, GMP/QSR compliance, FDA readiness audits, and planning, implementation, and training.

Partner with Syntegrate Solutions to ensure regulatory compliance, validation, and quality assurance across your organization, leveraging our extensive expertise and proven methodologies.