What We Do
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!)
Mark Newton, Heartland QA Principal
Mark has 34 years of experience in pharmaceutical laboratories, lab systems, LIMS, QA and computer systems at Eli Lilly and Company. He helped design and support an enterprise LIMS system, including user training and custom reports. For several years, Mark was an instructor for corporate courses for Validation of Computer Systems, and worked on teams that created validation deliverables. He authored the first corporate standard for qualification of computerized analytical equipment in GMP Laboratories, and led corporate remediation efforts for security of lab systems. He co-authored and trained lab personnel to identify and assess data integrity gaps in laboratory processes. He has nearly 20 years of experience in validating computer systems, from laboratory benchtop systems and spreadsheets, up through enterprise LIMS and SAP systems.
He is professionally active in ISPE/GAMP and has several published articles, in the area of validation and data integrity.
A detailed curriculum vitae is available upon request. Please use the Contact Us page to send your request. We look forward to speaking with you.
