Systems Validation
Computer System Validation (CSV) and Software Validation for Regulated Industries
Our Services
Computer System Validation
Mescada delivers end-to-end Computer System Validation (CSV) and software validation services for pharmaceutical, biotech, medical device, and other regulated industries. Our validation programmes are designed to demonstrate — and document — that your computerised systems do exactly what they are intended to do, consistently and reliably.
We apply a risk-based validation methodology aligned with GAMP 5 and applicable regulatory frameworks including 21 CFR Part 11, EU GMP Annex 11, and TGA guidelines. Whether you are validating a new SCADA system, upgrading a DCS, implementing an MES, or remediating an existing validated system, our team brings both deep technical knowledge and proven regulatory experience.
Because Mescada also designs and integrates the control and automation systems we validate, we offer a level of technical depth that pure validation consultancies cannot match. The result is faster protocol execution, fewer deviations, and audit-ready documentation that stands up to regulatory scrutiny from the TGA, FDA, and EMA.
Regulatory Frameworks We Work With
- GAMP 5 (Good Automated Manufacturing Practice)
- 21 CFR Part 11 (FDA Electronic Records)
- EU GMP Annex 11 (Computerised Systems)
- ICH Q10 (Pharmaceutical Quality System)
- TGA (Therapeutic Goods Administration)
- FDA 21 CFR Part 211 (GMP)
- ISO 13485 (Medical Devices)
- ISA-95 (Enterprise-Control Integration)
- ISA-106 (Procedural Automation)
- ISA-88 (Batch Control)
- ALCOA+ (Data Integrity Principles)
Our Process
Validation Lifecycle
We manage the full CSV lifecycle — from planning through to the final summary report — producing traceable, inspection-ready documentation at every stage.
Validation Master Plan (VMP)
We develop a Validation Master Plan that defines scope, strategy, responsibilities, and regulatory expectations — forming the backbone of your entire validation programme.
User Requirements Specification (URS)
We work with your teams to capture and formalise system requirements in a URS that provides the foundation for all downstream qualification and testing activities.
Design Qualification (DQ)
We review and document that proposed system designs meet the defined requirements before installation begins, reducing costly late-stage changes.
Installation Qualification (IQ)
We verify and document that systems are installed correctly according to manufacturer specifications, drawings, and site requirements.
Operational Qualification (OQ)
We test and document that systems operate as intended across their full operating range, including boundary conditions and alarm responses.
Performance Qualification (PQ)
We demonstrate and document that systems consistently perform to specification under real-world production conditions over an extended period.
Validation Summary Report (VSR)
We consolidate all validation evidence into a comprehensive summary report, providing the regulatory-ready documentation your auditors and inspectors expect.
Scope
Systems We Validate
We provide CSV and software validation across a broad range of computerised systems used in regulated manufacturing and quality environments.
SCADA & HMI Systems
Validation of supervisory control and data acquisition systems, human-machine interfaces, and operator workstations against GAMP 5 and applicable regulatory requirements.
DCS & Control Systems
Computer system validation for distributed control systems and PLCs used in regulated manufacturing environments, including Siemens PCS7, Rockwell and Honeywell platforms.
MES & Electronic Batch Records
Validation of Manufacturing Execution Systems, electronic batch record (eBR) systems, and Simatic IT — including 21 CFR Part 11 electronic signature and audit trail compliance.
Laboratory Systems (LIMS/LES)
Validation of Laboratory Information Management Systems and laboratory execution systems used in quality control and quality assurance environments.
Data Historians & Reporting
Validation of OSIsoft PI, data historians, and reporting platforms to demonstrate data integrity, accuracy, and traceability in regulated operations.
Cybersecurity & 21 CFR Part 11
Assessment and documentation of electronic records and electronic signature controls, access management, and audit trail requirements under 21 CFR Part 11 and EU Annex 11.
Why Choose Mescada for CSV?
Deep Process & Control Expertise
Because we also design and build the control systems, our validation teams understand the underlying technology — not just the paperwork. This means faster, more accurate protocols and fewer surprises during testing.
Regulated Industry Experience
We bring extensive experience across pharmaceutical, biotech, medical device, and food & beverage environments where CSV and regulatory compliance are non-negotiable.
Risk-Based Approach
Our validation strategies are risk-based and proportionate, following GAMP 5 principles so that validation effort is focused where it matters most — protecting patient safety and product quality.
Complete Documentation
From VMP to VSR, we produce clear, audit-ready documentation that holds up under regulatory inspection by the TGA, FDA, or EMA — covering IQ, OQ, PQ, traceability matrices, and deviation reports.
Need CSV support for your next project or remediation?
Talk to our validation team about your regulatory requirements and timelines.
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