Farmacovigilancia

Quality System and Audit

Viglya assists in designing and implementing a quality system that meets regulatory expectations (including the generation and streamlining of procedures and methodologies). Viglya helps clients prepare for upcoming internal and business partner audits and regulatory inspections to ensure their efficiency and success. Viglya also guides clients in developing Corrective and Preventive Action Plans (CAPAs) derived from audit findings.

  • Assessment, design, and management (control) of quality system for regulatory affairs and pharmacovigilance.
  • Generation, review, and streamlining of company policies, SOPs and Working Instructions/Guidelines.
  • Establishment of performance metrics: identification and monitoring of key performance indicators to help measure a client’s system performance and effectiveness.

  • Definition and oversight of compliance against internal processes, regulatory requirements, contractual agreements, and privacy and data protection laws. 
  • Assistance with ongoing monitoring of processes (internal and CRO/vendors) and deliverables (eg, ICSRs, PSURs, core labeling). Identification of process optimization and quality improvement. 

  • Elaboration of pharmacovigilance and regulatory audit programs.
  • Pharmacovigilance system audits of the global function, regional and local offices, business partners, CROs, and third-party vendors.
  • Definition, implementation, and supervision of CAPAs.

  • Conduct of mock inspections and inspection readiness exercises.
  • Design and delivery of training in preparation for inspections, including logistics, interviews, and role play.
  • Advice on inspection coordination and management activities.
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