Services
Modern GMP solutions reduce manual work, strengthen compliance, and improve documentation quality.
Stavigent supports pharmaceutical and biotechnology organizations in process optimization, deviation reduction, and the development of audit-ready documentation. The service portfolio integrates traditional GxP expertise (including GMP, GLP, and GCP frameworks covering manufacturing, laboratory, and clinical environments) with modern process automation to deliver compliant, AI-enabled solutions.
Stavigent identifies manual, error-prone steps in GxP workflows and creates practical automation solutions to significantly reduce human errors. Using a structured approach that includes process mapping, deviation/Corrective and Preventive Action (CAPA) trend analysis, and risk-based, Good Automated Manufacturing Practice (GAMP)- aligned planning, the service delivers clear automation opportunities and implementation guidance to enhance reliability, efficiency, and compliance.
Stavigent consolidates scattered or outdated GxP documents into a unified, compliant template system and enhances it with optional AI-supported drafting tools that comply with EU AI Act requirements. Using gap assessments, template benchmarking, and a structured style guide approach, Stavigent delivers consistent, audit-ready templates that minimize variability, accelerate reviews, and help teams produce clear documents more efficiently with full control and compliance.
Stavigent creates audit-ready validation and Quality Assurance (QA) documentation. Using a structured drafting and review process based on GxP, including Annex 11, GAMP 5 principles, and ICH E6, documents are created with clarity, consistency, and regulatory compliance.
Stavigent applies a structured, risk-based lifecycle approach to compliant system development, documentation, and validation. It aligns with GxP expectations and is informed by established industry frameworks, including Annex 11 principles, GAMP 5 guidance, and ICH E6 for clinical environments. It focuses on building inspection-ready documentation, ensuring traceability from requirements through testing, and supporting audit-ready validation packages throughout the system lifecycle.