Case study
Data Integrity & CSV Validation for Leading CDMO Company
for an Industry-Leading CDMO Company
Industry
Services
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Locations
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Total Units
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Manufacturing lines
System-wide Data Integrity Challenges
Significant data integrity gaps and equipment validation were the focus of this project.
Project Focus: Significant data integrity gaps and equipment validation.
We revamped the validation program to bring it into compliance with Good Automatic Manufacturing Practices (GAMP) requirements while improving efficiency. We validated three manufacturing fill lines within Grade A Isolators, validated laboratory equipment (hardware and software), and did temperature-related testing for CTUs.
ANSA carried out validation for over 200 pieces of equipment across five site locations throughout the United States.
When our work was concluded, all concerns around data integrity were thoroughly resolved, allowing the client to make optimal use of their resources.
What’s more: the project was completed within budget and before the projected completion date.
Data Integrity Remediation Project
5 Locations in 3 States
We began our work by remediating expiring Windows operating systems and implementing lockdown solutions for systems that could not be upgraded. From there, we were able to address the gaps in the client’s validation and operating procedures.
Validation Gap Remediation
ANSA took the following steps to identify and correct the client’s validation gaps:
We began our work by remediating expiring Windows operating systems and implementing lockdown solutions for systems that could not be upgraded. From there, we were able to address the gaps in the client’s validation and operating procedures.
- Security Policy Updates
- Data and Metadata Backup and Restoration
- Configuration Setup
- Functionality Testing
- Audit Trail Remediation Testing
- Validation Gap Qualifications Execution
Revised SOP Technical Writing
We formalized a new validation process by creating and revising Standard Operating Procedures (SOPs) for the client. This included administrative SOPs and validation documents.
Innovation begins with reliable data.
Computer System Validation for Manufacturing + the Laboratory
For the second element of this client’s project, ANSA identified and addressed gaps in their Computer System Validation (CSV) within their manufacturing and laboratory systems. This ensured all facilities were compliant and able to run optimally while meeting Food and Drug Association (FDA) regulations.
Validated 3 Manufacturing Filling Lines
Additionally, we performed validation on the client’s BMT Steam Sterilizers and Steris Parts Washer.
- Groninger filling line within a FranzZiel Isolator and PMS system-Pharmagraph for syringes
- Watson Marlow Flexicon within a FranzZiel Isolator and PMS System – Pharmagraph for vials
- SP Scientific fill line for Lyophilization with multiple integrated systems including validation of: rotary washer, depyrogenation tunnel, aseptic filler(Idositechno), SALS/Row By row, SP Lyophiliser S100, S20, Orabs ESCO Isolator and wireless glove testers, Idositechno Capper, External Vial washer and FactoryTalk Software
Laboratory System Validation
In conjunction with the client’s manufacturing equipment, we validated the following laboratory systems:
- MET One Particle Counters
- Sievers TOC Analyzers
- Thermo Fisher FTIR w/ Omnic software
- Thermo Fisher pH Meters
- Enterprise systems, including Empower 3 FR5 and NuGenesis SDMS/LMS
- Thermo Fisher MicroSEQ
- DLS-MALS Detector
- Spectrophotometers
- Particle Size Measuring Devices
- HPLC Systems
- Gas Chromatograph (GC) Systems
Controlled Temperature Unit Validations
Finally, ANSA completed this project by validating all the client’s Thermo Fisher Scientific brand CTUs including:
Ultra-low Freezers
Gravity Convection Ovens
Isotemp Muffle Furnaces
Testing Within Installation, Operational, and Performance Qualifications
Our validation procedure included rigorous testing of the client’s CTUs:
24-hour temperature mapping, including an empty chamber distribution study and loaded chamber distribution study
Door open recovery testing
Power down/failure recovery testing
EMS monitoring system verification and investigations
