Quality
Ensuring Excellence Through Quality Assurance & Quality Control
At Synterex, we help organizations uphold the highest standards of accuracy, compliance, and consistency in clinical and regulatory documentation. Quality assurance (QA) ensures that strong processes are in place to prevent errors while also conducting retrospective reviews, audits, and continuous improvement initiatives to refine planning and risk mitigation strategies. Quality control (QC) provides a critical layer of oversight, systematically reviewing documents and data to identify and correct issues before submission. Together, these services ensure that your deliverables meet industry expectations with precision, reliability, and continuous optimization.
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Regulatory document audits
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Standard operating procedure (SOP) development
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Trial master file (TMF) audits
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Training (eg, GCP, FDA regulations, GDP)
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Inspection support
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Compliance review (eg, SOPs, guidances)
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Process gap analyses
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Risk management and mitigation planning
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Corrective and preventive actions (CAPA) management
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Vendor and CRO audits
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Mock regulatory inspections
Computer System Validation (CSV)
Synterex provides computer system validation (CSV) services to ensure automated, digital, and AI‑enabled systems used in regulated environments are fit for their intended use. Validation activities follow risk‑based principles and are designed to support agile, incremental system evolution without compromising control.
We support validation of document management platforms, quality management systems, eTMF solutions, SaaS technologies, and AI‑enabled applications used within GxP workflows. Our approach enables organizations to adopt automation and AI confidently, while maintaining validation strategies that are sustainable as systems evolve.
CSV services may include master validation planning, intended use and risk assessments, validation documentation, testing and traceability, and support for change control and periodic review. IT Quality Assurance and Clinical QA activities are coordinated to support inspection readiness in increasingly automated and agile operating models.
Technology Solutions
We are thought leaders on the use of automation/logic-based programming and AI for patient data and patient-facing documents. Innovations include:
AgileWriter.ai®
First-in-class AI tool for composing and managing clinical trial documents
Synterex also is a Microsoft Cloud AI Partner, which positions us to work closely with product management at one of the largest tech companies in the world to advocate for clients and deliver best-in-class user experiences.
Learn more about how we're leveraging technology for the good of the patient.