Pharmaceutical LIMS

Pharmaceutical LIMS: Quality Control for Regulated Industries

Pharmaceutical quality control laboratories operate under some of the most stringent regulatory requirements in the analytical testing industry. FDA regulations, cGMP requirements, and international standards demand complete documentation, data integrity, and audit trail capabilities.

Omega LIMS provides pharmaceutical laboratories with the tools needed to meet these requirements while maintaining operational efficiency.

Regulatory Compliance Features

21 CFR Part 11 Compliance: Electronic signatures, audit trail, user authentication, and data integrity features that support Part 11 requirements.

Complete Audit Trail: Every data entry, modification, and deletion is recorded with timestamp, user identification, and reason for change.

Electronic Signatures: Secure electronic signatures for data review, batch release, and document approval.

User Access Control: Role-based permissions ensure users can only access and modify data appropriate to their responsibilities.

Pharmaceutical Testing Support

• Stability Testing: Manage ICH stability programs with automatic scheduling, environmental condition tracking, and trend analysis.
• Batch Release: Workflow management for batch review and release with electronic approval.
• Specification Management: Define product specifications with automatic pass/fail determination.
• OOS Investigation: Out-of-specification investigation tracking and documentation.
• Method Validation: Documentation support for method validation studies.

Data Integrity (ALCOA+)

Omega LIMS supports ALCOA+ data integrity principles:

• Attributable: Every entry linked to the user who made it
• Legible: Electronic data always readable and retrievable
• Contemporaneous: Timestamps record when data was entered
• Original: Original data preserved, changes tracked
• Accurate: Validation rules and QC checks ensure data accuracy

Meet Pharmaceutical Requirements: Request a demo to see how Omega LIMS supports pharmaceutical QC operations.