ISO 9001:2015 Certified Quality System
AnalytiLab operates under a comprehensive Quality Management System certified to ISO 9001:2015 and accredited to ISO 17025:2017. Our QMS is designed to ensure consistent quality, data integrity, and regulatory compliance across all laboratory operations.
Every process — from sample receipt to report issuance — is governed by validated SOPs, reviewed by qualified personnel, and documented with full audit trails. Our QMS is regularly audited by NABL, USFDA, and our clients.
Standard Operating Procedures (SOPs)
Over 200 validated SOPs covering all laboratory operations, instrument use, sample handling, and data management.
Internal Audit Program
Quarterly internal audits by trained auditors; findings tracked to closure with CAPA implementation.
Management Review
Annual management review of QMS performance, customer feedback, audit results, and quality objectives.
Training & Competency
Structured training program for all staff; competency assessments before independent work authorization.
Change Control
Formal change control process for all changes to methods, instruments, personnel, and facilities.
Deviation & CAPA Management
Systematic deviation investigation, root cause analysis, and corrective/preventive action tracking.
cGLP Compliance
Study Director Accountability
Each study has a designated Study Director responsible for the overall conduct, data integrity, and final report.
Master Schedule
Comprehensive master schedule maintained for all ongoing studies with status tracking and resource allocation.
Archive Management
Secure, climate-controlled archive for all raw data, reports, and specimens with defined retention periods.
Specimen Integrity
Chain of custody maintained for all samples; storage conditions monitored and documented throughout.
Raw Data Integrity
All raw data recorded contemporaneously; electronic data protected with audit trails and access controls.
QA Unit Independence
Independent Quality Assurance unit conducts study audits, facility inspections, and report reviews.
ALCOA+ Principles
All data generated at AnalytiLab adheres to ALCOA+ principles, ensuring the highest standards of data integrity for regulatory submissions.
Attributable
All data is attributed to the person who generated it, with date and time stamps.
Legible
All records are legible, permanent, and readable throughout the retention period.
Contemporaneous
Data is recorded at the time the activity is performed, not retrospectively.
Original
Original records are preserved; copies are verified against originals.
Accurate
All data accurately reflects the observations and measurements made.
Complete, Consistent, Enduring, Available
Extended ALCOA+ principles ensuring comprehensive data integrity across all records.
Always Inspection Ready
Regulatory Inspections Passed
Client Audit Support
We welcome client audits and provide full support for pre-audit questionnaires, on-site audits, and post-audit responses. Our QA team ensures all documentation is readily available.
Questions About Our Quality System?
Our QA team is available to discuss our quality practices and support your audit requirements.