A focused
practice, deep
expertise.
Three core engagements, each built on direct lab experience. Whether you need to remediate a single failed audit finding or rebuild a quality system from the ground up, the work is hands-on and written by someone who has actually run the methods.
SOP Writing & Remediation
Clear, compliant standard operating procedures written by someone who has actually run the methods. From inorganic wet chemistry to GC/MS volatiles — every SOP is field-tested, regulator-ready, and structured to survive personnel turnover.
Whether you need a single SOP written from scratch or a full library remediated ahead of an audit, the deliverables are built around how your analysts actually work — not a generic template.
Deliverables
- Method-specific SOPs (microbiology, wet chemistry, metals, organics)
- QC procedure documentation and acceptance criteria
- SOP gap analysis and prioritized remediation plan
- Document control system setup
Methods I've worked with
Typical engagement
2 – 6 weeks
Scoped per method or per department. Fixed fee, no hourly billing.
Audit Prep & Gap Assessments
Systematic readiness reviews for NELAC, MA DEP, A2LA, and state-specific accreditation renewals. Mock audits, evidence packages, finding response strategy — everything you need to walk into your assessment confident.
I've sat in the room when the assessors arrive. I know what they look for, what they flag, and what they let slide. That perspective shapes every gap assessment I deliver.
Deliverables
- Gap assessment report with prioritized findings
- Audit readiness checklist by accrediting body
- CAPA documentation and root cause analysis
- Certification scope review and expansion planning
- Mock audit walkthroughs
Accrediting bodies
Typical engagement
4 – 12 weeks
Timed to your accreditation calendar. Start at least 8 weeks before your assessment date.
LIMS Support & Method Validation
Configuration, troubleshooting, and data migration for Element, TALS, and similar LIMS platforms. Method validation packages that satisfy TNI standards and document precision, accuracy, and MDL studies in a form your assessor will recognize.
I've migrated a lab from fully paper-based records to a paperless LIMS workflow. I know where the pain points are and how to build configurations around analyst workflow, not the vendor's demo path.
Deliverables
- LIMS method code and limit group configuration
- Data import and migration from paper or legacy systems
- Method validation packages (MDL, DOC, precision, accuracy)
- Control chart setup and verification scheduling
- User permission and workflow configuration
Systems
Typical engagement
1 – 8 weeks
Scoped per system or per validation. Can run alongside SOP or audit work.