PHARMACEUTICAL LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS) AUDIT CHECKLIST 2026

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--- SYSTEM ADMINISTRATION AND USER ACCESS CONTROL ---
[ ] Audit Date
[ ] Auditor Name
[ ] System Access Level Audited (Administrator, Super User, Laboratory Technician, Quality Assurance Reviewer, Read-Only User)
[ ] Access Control Checks Performed (Password Complexity Verification, User Role/Permission Review, Inactive Account Deactivation Check, Unauthorized Access Attempt Review, Segregation of Duties Verification)
[ ] Observations and Discrepancies
[ ] User Access List Evidence
[ ] Auditor Signature

--- DATA INTEGRITY AND AUDIT TRAIL REVIEW ---
[ ] Audit Trail Review Frequency (Daily, Weekly, Monthly, Per Batch/Lot)
[ ] Audit Trail Verification Parameters (User ID Identification, Timestamp Accuracy, Old Value vs New Value Comparison, Reason for Change Documentation, Data Deletion Attempts)
[ ] Date of Audit Trail Review
[ ] Discrepancies or Anomalies Identified
[ ] Supporting Audit Log Export
[ ] Auditor Verification Signature

--- CONFIGURATION MANAGEMENT AND VALIDATION ---
[ ] Last Validation Date
[ ] Validation Status (Validated, In-Progress, Failed, Out of Date)
[ ] Summary of Configuration Changes
[ ] Upload IQ/OQ/PQ Documentation
[ ] Verified Parameters (User Access Rights, Workflow Logic, Data Fields/Metadata, Reporting Templates, Audit Trail Configuration)
[ ] Validator Signature

--- SAMPLE LIFECYCLE MANAGEMENT ---
[ ] Sample Collection Date
[ ] Sample Identification/ID Number
[ ] Sample Type (Raw Material, In-Process, Finished Product, Stability Sample)
[ ] Required Testing Parameters (pH Testing, Dissolution, Assay, Impurity Profile, Microbial Limit Test)
[ ] Storage Location/Reference
[ ] Initial Lab Notebook Entry/Scan
[ ] Analyst Verification Signature

--- INSTRUMENT INTEGRATION AND INTEROPERABILITY ---
[ ] Instrument Connection Type (Direct Interface (Automated), Manual Data Entry (LIMS Input), CSV/File Import, Middleware Integration)
[ ] Instrument ID/Asset Number
[ ] Data Transfer Methods Verified (Auto-parsing of raw data, Electronic signature capture, Real-time status updates, Error/Alert notification)
[ ] Last Integration Testing Date
[ ] Interface Validation Protocol/Report
[ ] Auditor Verification Signature

--- REPORTING AND ANALYTICAL OUTPUT ---
[ ] Report Type Audited (Certificate of Analysis (CoA), Stability Summary Report, Audit Trail Summary, Inventory/Reagent Report)
[ ] Verified Data Attributes (Time-stamps, User Identities, Calculated Results, Unit of Measure, Approval Status)
[ ] Report Generation Date
[ ] Report Reference Number
[ ] Discrepancies Identified in Output
[ ] Upload Sample Report for Review
[ ] Auditor Verification Signature

--- BACKUP, RECOVERY, AND DISASTER MANAGEMENT ---
[ ] Last Backup Completion Date
[ ] Backup Frequency Compliance (Daily, Weekly, Monthly, As Required)
[ ] Backup Storage Locations (On-site Server, Off-site Cloud Storage, Secondary Data Center, Encrypted Physical Media)
[ ] Disaster Recovery Test Summary
[ ] Backup Logs and Verification Report
[ ] Auditor Verification Signature

--- SYSTEM MAINTENANCE AND CHANGE CONTROL ---
[ ] Date of Change Implementation
[ ] Change Control Reference ID
[ ] Description of System Update or Patch
[ ] Impact Level of Change (Minor, Major, Critical)
[ ] Components Affected (Database, User Interface, Instrument Interface, Report Templates, Security Permissions)
[ ] Supporting Validation/Testing Documentation
[ ] Quality Assurance Approval Signature

--- COMPLIANCE WITH 21 CFR PART 11 AND ANNEX 11 ---
[ ] Electronic Signature Verification Status (Compliant, Non-Compliant, Not Applicable)
[ ] Audit Trail Review Components (User ID, Timestamp, Original Value, New Value, Reason for Change)
[ ] Last Audit Trail Review Date
[ ] Description of Identified Discrepancies
[ ] Evidence of Electronic Signature Validation Report
[ ] Auditor Authentication

--- USER TRAINING AND OPERATIONAL SOPS ---
[ ] Last Training Session Date
[ ] Training Completion Status (Completed, In Progress, Not Started, Overdue)
[ ] Training Modules Covered (System Administration, Sample Entry & Logging, Data Analysis & Reporting, Audit Trail Review, Incident Management)
[ ] Training Evidence/Certificate Upload
[ ] Training Gap Analysis & Corrective Actions
[ ] Auditor Verification Signature

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