Vigilance quality management

Sunnikan handles all kinds of vigilance

Sunnikan ensures regulatory compliance and efficiency for pharmacovigilance processes by offering suitable solutions: regulatory assistance and monitoring, pharmacovigilance audits, procedure drafting, IT system validation.
Sunnikan also works on clinical trial vigilance, material vigilance and cosmetics vigilance.

Through its recommendations, services and training schemes, Sunnikan works with pharmaceutical laboratories with marketing authorisations and/or companies and their service providers (‘CSO’, Contract Safety Organization), medical equipment manufacturers, clinical trial sponsors and contracted research companies seeking to:

  • Develop, roll out and maintain quality management systems
  • Improve their pharmacovigilance processes,
  • Ensure regulatory compliance,
  • Audit their systems or subcontractors,
  • Validate (or audit) their IT systems or changes (‘change control’),
  • Prepare for an inspection or handle follow-up.

Safety Observer

Pharmacovigilance regulatory monitoring in partnership with PV Focus
www.safetyobserver.com

The monthly newsletter includes a summary of texts and direct links to all new regulations and initiatives that fall within the scope of pharmacovigilance. This includes regulatory texts, draft bills, product notifications, etc.

Diagnosis and audits

Around the world

  • Pharmacovigilance services organisation diagnosis
  • Process efficiency diagnosis
  • Regulatory compliance diagnosis ('gap analysis')
  • Organisational, regulatory, system audits (parent company, subsidiary)
  • Service provider audits (qualification audits, monitoring audits)
  • IT system validation audits

Preparing for inspections and follow-up

(ANSM, MHRA, etc.)

  • Setting up a pre-inspection plan
  • Pre-inspection checks
  • Preparing the necessary paperwork
  • Preparing a response to the inspection report
  • Monitoring the action plan

Training sessions

  • European and French regulations, GVP
  • Quality management systems, audits, validating IT systems, standard operational procedures
  • Preparation for inspections

Quality management systems

  • Developing and updating documentary systems
  • Drawing up Pharmacovigilance System Master Files (PSMF), delegating tasks
  • Drawing up standard operational procedures
  • Drawing up procedure appendices (operating methods, document templates, forms, check-lists, etc.)
  • Drawing up role descriptions
  • Drawing up specifications

Validating IT systems

In compliance with GAMP 5, 21 CFR Part 11

  • Training
  • Validation process
  • Drawing up validation procedures
  • Drawing up validation process documentation
  • Carrying out tests

Our training programmes

Read the programme

As a training body, Sunnikan offers regulatory and quality training sessions

Our regulatory monitoring

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Sunnikan offers monitoring and support tools to help companies keep up to speed on their regulatory obligations