About Us
You can expect us to bring....
- An ear to hear your objectives and constraints
- Straight answers and options
- Passion for improving the quality of your organization
- Time-tested experiences
- Risk-based thinking: most benefit for least effort
- Objective, data-focused viewpoint
- Knowledge of the regulatory climate
- Long-term thinking
Our expertise is....
Data Integrity and Governance
Computer Systems Validation
Computer-controlled Analytical Instrument
Qualification
Quality Assurance and Standards
Quality Control Laboratory
LIMS/ELN
We excel at...
Data Integrity Metrics
Process Mapping to identify data integrity gaps
Writing/reviewing standards, procedures and
validation deliverables
Developing quality standards for practices
Requirements-gathering sessions for systems
Prioritizing requirements (critical, other)
Reviewing requirements for regulatory compliance/data
integrity
Reviewing systems for data integrity
gaps/recommended remediations
Training for quality system and/or data
integrity and data governance
Periodic Review
Analytical computerized systems: procedures,
protocols
Inspection preparation (esp. laboratories!)