COMPLIANCE SELF-ASSESSMENT
Lab Compliance
5-Minute Quick Self-Check
An interactive self-assessment checklist covering five dimensions: GMP, GLP, CNAS, 21 CFR Part 11, and Data Integrity (ALCOA+). Check items one by one, get instant scoring, discover compliance blind spots, and identify improvement directions.
INTERACTIVE CHECKLIST
Interactive Self-Assessment Checklist
Check the items your lab already meets. The system automatically calculates scores for each dimension and overall compliance maturity. Unchecked items represent potential improvement areas.
GMP Good Manufacturing Practice
0/6Electronic Batch Records
Are production batch records electronically managed with version control and change history traceability?
High Risk β FDA/EMA inspection focus
Audit Trail
Are all key data changes recorded with audit trails including operator, timestamp, before/after values, and change reason?
High Risk β Core data integrity requirement
Electronic Signatures (21 CFR Part 11)
Are electronic signatures unique and non-repudiable, bound to records and not copyable/pasteable?
High Risk β Mandatory regulatory requirement
Analytical Method Validation Management
Are method validation data systematically managed with method version traceability and equivalency assessment?
Medium Risk β Method lifecycle management
OOS/OOT Investigation Process
Are out-of-specification/out-of-trend investigation processes standardized and systematized with CAPA closed-loop tracking?
Medium Risk β Core quality system process
Stability Study Management
Are stability study protocols, sampling plans, and data trend analysis systematically managed?
Low Risk β Efficiency improvement
GLP Good Laboratory Practice
0/5Study Protocol Management
Are study protocols electronically managed with approval workflow, version control, and deviation recording?
High Risk β Core GLP compliance
Raw Data Integrity
Does raw data follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available)?
High Risk β Data integrity foundation
Equipment Calibration & Maintenance Records
Are instrument calibration, maintenance, and validation records electronic with expiration alerts and status tracking?
Medium Risk β Equipment lifecycle
Reference Standards & Reagent Management
Are reference standards, reagents, and solutions electronically managed with expiration alerts, opening records, and usage traceability?
Medium Risk β Basic lab management
QA Review & Deviation Management
Are QA review findings and deviations systematically recorded, distributed, tracked, and closed in a loop?
Medium Risk β Quality assurance system
CNAS Testing & Calibration Lab Accreditation
0/5Electronic Test Reports
Are test reports electronically generated, reviewed, and issued in compliance with CNAS-CL01 report content requirements?
High Risk β CNAS assessment focus
Method Verification & Validation Records
Are standard method verification / non-standard method validation records systematically managed with audit traceability?
High Risk β Methodology management
Proficiency Testing (PT) Management
Are proficiency testing plans, results, and corrective actions systematically tracked and archived?
Medium Risk β CNAS ongoing monitoring
Internal Audit & Management Review
Are internal audit plans, checklists, findings, and management review inputs/outputs electronically managed?
Medium Risk β Core system operations
Personnel Qualification & Training Records
Are tester qualification authorizations, training records, and competency monitoring systematically managed?
Medium Risk β Personnel competency management
21 CFR Part 11 Electronic Records & Electronic Signatures
0/6System Access Control
Are unique user ID + strong password policies implemented, with multi-factor authentication (MFA) and periodic password rotation?
High Risk β Β§11.10 Access controls
Role-Based Access Control
Are permissions separated by role (RBAC) with clear segregation between operator, reviewer, and administrator?
High Risk β Conflict of interest prevention
Electronic Signature Uniqueness
Is each electronic signature bound to a unique user and include signature meaning (e.g., "Reviewed", "Approved")?
High Risk β Β§11.50 Signature requirements
Tamper-Proof Audit Trail
Are audit trails auto-generated by the system, non-disablable and non-editable by users, and exportable/readable?
High Risk β Β§11.10(e) Audit trails
System Validation Documentation
Has the system completed IQ/OQ/PQ validation with complete validation documentation retained?
Medium Risk β System compliance foundation
Data Backup & Disaster Recovery
Are regular backup mechanisms and disaster recovery plans established, with backup data recoverability verified?
Medium Risk β Business continuity
ALCOA+ Data Integrity Principles
0/5Attributable
Can all data be traced to its originator (person) or source system (instrument), with no anonymous records?
High Risk β First principle of data integrity
Contemporaneous
Is data recorded at the time of generation or observation, not retrospectively? Does the system enforce timestamps?
High Risk β Eliminating "backdating"
Original (Original Data Protection)
Are original data/records protected and non-overwritable? Are modifications recorded via audit trails rather than direct edits?
High Risk β Original data integrity
Accurate + Enduring
Does data accurately reflect actual observed values? Is the storage medium durably readable throughout the data lifecycle?
Medium Risk β Data quality & long-term preservation
Complete + Consistent + Available
Does the dataset include all replicate, retest, and failed data? Is it consistent across systems? Can authorized personnel retrieve it at any time?
Medium Risk β Data governance framework
SCORE DASHBOARD
Compliance Score Dashboard
Based on your selections, real-time display of compliance maturity across dimensions. Scoring is for self-assessment reference only and does not substitute for a formal compliance audit.
0/6
GMP Compliance
0/5
GLP Compliance
0/5
CNAS Compliance
0/6
21 CFR Part 11
0/5
ALCOA+ Data Integrity
0/27
Overall Compliance Maturity
Identifying Gaps Is Only the First Step
CNWAYLab compliance consulting team offers a free on-site Gap Analysis service,
helping you develop a practical compliance improvement roadmap and system implementation plan.