MasterControl Customer Complaints™
MasterControl Customer Complaints™
Quality products and processes are increasingly important in today’s global market. Ineffective quality
management systems jeopardize submissions, lead to regulatory agency findings, cost time and
money, and, worst case, adversely affect consumers’ health. Companies are increasingly turning their
attention to QMS solutions that provide corporate control and oversight of all quality and compliance
activities and actions.
Chosen by more than 50% of the top 20 pharmaceutical companies alone, MasterControl QAAD is a
comprehensive, user- configurable and -validated, off-the-shelf software tool designed and developed
by people who have years of experience in Quality and, as a result, truly understand your business.
MasterControl QAAD guarantees in-house expertise during each phase of your project and solution
rollout. You can be assured of dedicated personnel at all times, as no aspect of our services is ever
outsourced.
QAAD’s web-based response entry interface, known as QWBRE, allows response and CAPA
tracking:
• Records events directly into the database
• Provides complete CAPA recording and tracking
• Employs automatic escalation features
Trending is an important tool when used effectively. MasterControl QAAD allows you to:
• Analyze all data for trend and metrics reporting
MasterControl QAAD is a reliable, easy-to-use reporting tool, with functionality that allows users to:
• Create and print customized reports without having to possess knowledge of the database
schema
• Export to EXCEL, PDF or CSV
• View reports through QWBRE
• Schedule reports to run on a one-time basis—or, daily, weekly or monthly
Specific regulatory requirements built into the software meet the specific needs of research quality
assurance (RQA) groups.
• GLP (OECD, FDA, EPA): Master schedule, QA statements, multi-site studies, study-based
process inspections
• GCP (ICH, GCVP): Compliance statement, clinical trial key data and Ethics Committee information
• GMP (FDA, EU): Vendor/supplier management, inspections; batch release; evaluation by qualified
person facilitated
In addition to GCP, GLP and GMP audits, QAAD is also used for the following quality assurance
activities:
• Pharmacovigilance audits
• Computer systems audits
• Third-party evaluations and assessments
• Regulatory inspections
• Corporate audits
• Environmental audits
• CAPA
• Nonconformances
• Complaints