Attributable
Every data point is traceable to the person who generated it. Electronic signatures and user-specific logins ensure accountability.
Quality & Compliance
Robust quality systems designed to deliver defensible analytical results. cGMP alignment, GLP principles, ALCOA-compliant data integrity, and comprehensive documentation practices.
ALCOA Data Integrity
cGMP/GLP Alignment
Qualified Instruments
Complete Documentation
ALCOA Data Integrity
All data generated follows FDA ALCOA principles, ensuring complete, consistent, and accurate records
Legible
All records are clear, readable, and permanent. Electronic data is stored in validated systems with searchable formats.
Contemporaneous
Data is recorded at the time of the activity. Timestamps on electronic records ensure temporal accuracy.
Original
Original records (or certified true copies) are preserved. First-captured electronic data is the original record.
Accurate
Data reflects actual observations and results. Any corrections are documented with original entries preserved.
Complete & Consistent
ALCOA+ principles: Records are complete (including repeat/reprocessed data) and consistent with expected formats and protocols.
Quality Systems
Comprehensive quality management supporting compliant analytical operations
Instrument Qualification
All analytical instruments are qualified per established protocols.
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Ongoing performance verification
Calibration & Maintenance
Regular calibration and preventive maintenance programs ensure reliable results.
- Scheduled calibration intervals
- NIST-traceable standards
- Preventive maintenance programs
- Calibration records and certificates
Change Control
Formal change control procedures for methods, equipment, and systems.
- Change request documentation
- Impact assessment
- Approval workflows
- Implementation verification
Deviations & CAPA
Systematic deviation handling and corrective/preventive action processes.
- Deviation documentation
- Root cause investigation
- Corrective actions
- Effectiveness verification
Documentation & Reporting
Comprehensive documentation packages designed for regulatory review and quality decisions
Certificate of Analysis
Comprehensive CoA packages with all required elements for release decisions.
- Test results and specifications
- Method references
- Acceptance criteria
- Authorized signatures
Raw Data Packages
Complete raw data available on request for audit support and regulatory review.
- Chromatograms and spectra
- Integration parameters
- System suitability data
- Calculations and formulas
Investigation Support
OOS/OOT investigation support and additional testing as needed.
- OOS investigation protocols
- Retest/reinvestigation support
- Root cause analysis assistance
- Technical consultation
Questions About Our Quality Systems?
Contact us to discuss your compliance requirements or request additional quality documentation.
Discuss Your Quality Requirements
Have specific compliance questions? Our team is ready to discuss your analytical and documentation needs.
Specializations
Herbicides, fungicides, insecticides, surfactants, and technical materials
Fast Turnaround
3-day delivery for urgent QC and regulatory testing needs