Digital Transformation of QC Labs: From Paper-Based Legacy to Integrated LES
Industry
Biotech / CDMO / Life Sciences
Scope
Laboratory Execution System (LES), IT/OT Integration, GxP Compliance, Business Analysis, Architecture Design
Timeframe
2 Months (Analysis & Design Phase)
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+300
Core business requirements collected and categorized
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+5
Laboratory instruments analyzed for connectivity.
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100%
Planned elimination of paper logbooks and manual transcription.
01
CLIENT
A leading European Biologics Contract Development and Manufacturing Organization (CDMO) operating multiple high-tech facilities looking to modernize disconnected laboratory environments across its distributed sites.
02
BUSINESS NEEDS
The client aimed to increase operational effectiveness and elevate GxP compliance within their Quality Control (QC) laboratories by eliminating disconnected equipment and paper-based processing. The strategic goal was to implement a Laboratory Execution System (LES) acting as a "Single Source of Truth," ensuring audit readiness and eliminating manual transcription errors.
03
CHALLENGE
To help our client achieve its goals, we overcome the following challenges:
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Data Integrity & Compliance Risks
The paper-based process relied on manual transcription, leading to high risks of error and violations of ALCOA+ principles. -
Lack of Standardization
There was a confirmed gap in process harmonization between the client's two major sites, leading to inconsistent compliance. -
Hardware & Security Blockers
Technical analysis identified incompatible legacy hardware and unencrypted protocols posing network security risks. -
Operational Silos
Data was locked in physical logbooks or local instrument memory, making real-time oversight and trend analysis impossible.
04
SOLUTION
We delivered a comprehensive Analysis & Design phase, mapping the path to a fully integrated Laboratory Execution System (LES) that orchestrates people, instruments, and IT systems into one cohesive platform. The solution entailed:
- Harmonized "To-Be" Workflows Designing unified digital processes for pH, Balance, and Conductivity measurements, enforcing a single standard across all sites.
- Proactive GxP Enforcement Moving from detective to preventive controls by verifying Analyst Training and Instrument Calibration status in real-time.
- IT/OT Integration Architecture Designing a High Availability architecture with secure "Room Gateways" to isolate Layer 1 instruments from the corporate network.
- Automated Data Capture Ensuring 100% automated data capture from instruments directly to the LIMS/LES layer using barcode scanning.
Moving from a 'world on paper' to a digital ecosystem required more than just software; it demanded a cultural and process revolution. By establishing the LES as the Single Source of Truth, we are not just automating data entry - we are proactively enforcing compliance. The system now validates the analyst, the instrument, and the method in real-time, reducing GxP risk to near zero while drastically accelerating batch release times.
Łukasz Paciorkowski
CEO A4BEE
Technology used
05
OUTCOME
The Analysis & Design phase provided a clear blueprint for transforming the client's QC operations, turning technical hurdles into a competitive advantage. The project resulted in a robust plan to fundamentally transform operational capabilities, enhance compliance, and create a more efficient, data-driven laboratory environment.
- 100% Elimination of Errors The designed process removes manual data entry, ensuring data is Attributable, Legible, and Accurate (ALCOA+).
- 24/7 Audit Readiness Replacement of fragmented paper trails with a single, secure, and immutable electronic audit trail compliant with 21 CFR Part 11.
- Accelerated Review Cycles Reducing data review times from days/weeks to minutes by providing immediate access to validated data packages.
- Reduced Contamination Risk Automated, remote data backups eliminate the need for IT personnel to physically enter cleanrooms.
06
IMPLEMENTED SOLUTION
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Compatibility Matrix
Physical verification of 43 instruments, categorizing them by integration readiness and defining upgrade paths. -
Failover Architecture
Continuous redundancy with failover protocols guaranteeing Recovery Point Objective (RPO) for key data. -
Protocol Standardization
Standard integration protocols (MT-SICS, XML) ensuring bidirectional communication and remote control. -
Business Requirements
Collection and categorization of +300 core business requirements and analysis of laboratory instruments.
-
+300
Core business requirements collected and categorized
-
+5
Laboratory instruments analyzed for connectivity.
-
100%
Planned elimination of paper logbooks and manual transcription.
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