"Pietrek Associates stands for quality and commitment."
Divisional Vice President, Quality Management
"Your pharmacovigilance audit helped us to get smoothly through FDA and MHRA inspections."
Vice President, Safety Operations
Since inception in 2009 Pietrek Associates’ team members have conducted more than 450 GVP and GCP audits, mock inspections and trainings for inspection readiness at small to large pharmaceutical, biotechnology companies and service providers world-wide. Pietrek Associates audits follow a consultative approach, which often results in Quality Management System (QMS) enhancements.
Quality Management Cycle
Key Deliverables – Quality by Intention
Quality Management System (QMS)
- Review of current QMS
- Definition/ enhancement of processes (end-to-end)
- Interfaces of quality systems
- Writing of Standard Operating Procedures, working instructions, job descriptions, team/committee charters, templates
Quality System Oversight
- Knowledge, issue and change management
- Alignment of quality systems and corporate governance
- Development of performance metrics / KPIs and periodic reports (trending)
- Facilitation of Quality Management Reviews
Quality Control
- Ongoing monitoring of processes and detailed review of outputs
- Staff and vendor qualification, and compliance oversight
- IT system performance
Remedial Actions
- Implementation and supervision of CAPAs
- Design and management of quality improvement initiatives
- Measuring effectiveness and reporting progress
Quality Assurance
- Development of audit strategy and annual audit program
- Targeted and system GPV & GCP audits
- Inspection readiness/mock inspections
- Support of inspection responses and commitments
- Evaluation of the QA system
Example: Error Rate in Safety Data Processing
A client was concerned about the error rate in safety data processing. Pietrek Associates worked with the client and the CRO on a plan, which was agreed and implemented.