LDAS (Laboratory Data Acquisition System) is designed for use in GLP-compliant laboratories, ensuring that data generated from scientific instruments and applications is managed in accordance with GxP regulations. This document outlines the approach adopted by LDAS to maintain data integrity, traceability, and regulatory compliance, with a focus on 21 CFR Part 11 and ALCOA+ principles.

Compliance Assessment

A compliance assessment is conducted to evaluate both the technical and procedural aspects of LDAS. This ensures that:

The system adheres to 21 CFR Part 11 requirements.
Data integrity is maintained through ALCOA+ principles.
Built-in technical controls and system features are sufficient to meet regulatory expectations.

LDAS captures raw data directly from laboratory instruments and converts it into a standardized, machine-readable JSON format. During this process, the system performs automated integrity checks to validate the data against ALCOA+ standards. It also incorporates exception handling mechanisms to detect anomalies such as missing or inconsistent data. Any discrepancies are automatically flagged and logged for review, ensuring that only validated and reliable data is retained.

The parsed data is enriched with comprehensive metadata—including source, timestamp, instrument settings, user ID, and version history—enabling structured data review. Authorized users can verify and approve the data before it is archived, ensuring accuracy, completeness, and compliance with regulatory standards.

Key GxP Features of LDAS

Robust Access Controls

Role-based access ensures that only authorized users can access or modify data.

Detailed Audit Trails

Every data event—from capture to archival—is logged with timestamps, user actions, and system responses, ensuring full traceability.

Secure Electronic Signatures

Compliant with regulatory standards for authentication and approval.

Archival Policy

Data is stored according to defined retention policies, transitioning from primary to secondary storage for long-term preservation.

Data Review Workflows

Captured data is metadata-tagged (source, timestamp, instrument settings, user ID, version history) and reviewed by authorized users before archival, ensuring accuracy and completeness.

End-to-End Validation Package

To ensure that the LDAS performs reliably and accurately in regulated environments, a validation exercise is conducted. This process confirms that the system functions as intended and meets all specified requirements.

Risk-Based Validation Approach

LDAS follows a risk-based validation methodology, where each system feature is assessed for its impact on data integrity and compliance. Based on this assessment, appropriate levels of testing rigor are applied. This ensures that critical functionalities are thoroughly validated while maintaining efficiency.

Qualification Phases

The validation process includes two key qualification stages:

Installation Qualification (IQ): Verifies that LDAS components are installed correctly and according to specifications.
Operational Qualification (OQ): Confirms that LDAS operates as expected under defined conditions and performs its intended functions.

Scope of Validation

The validation package covers the following core modules of LDAS:

Platform

Includes user management, system configuration, and audit logging capabilities.

Instrument Integration

Ensures accurate and real-time acquisition of data from laboratory instruments, along with proper transformation into standardized formats.

Archival Module

Validates secure storage of data in various formats, aligned with retention and compliance policies.

Orchestration Module

Confirms seamless coordination of data flow across instruments and applications.

Traceability and Documentation

To maintain transparency and accountability:

Test scripts are directly mapped to system requirements, ensuring complete traceability throughout the validation lifecycle.
A comprehensive user manual and vendor-provided validation package are included to support customer-specific validation needs, such as custom integrations, deployment configurations, and environment-specific setups.

LDAS is a GxP-ready solution that supports compliant data acquisition, management, and storage in regulated laboratory environments. Its validation package and built-in compliance features make it suitable for deployment across a wide range of GxP applications, ensuring data integrity, traceability, and regulatory alignment.