SERVICE 05/06
Validation that keeps pace with delivery
GAMP 5 CSV and CSA, data integrity, and Part 11 and Annex 11 readiness, from engineers who also build the systems.
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Compliance, Validation & Quality
In regulated manufacturing you cannot trade speed for compliance. Validation is often where projects slow down, because documentation is written after the fact by people who did not build the system.
Our CSV engineers work alongside our automation and data teams from the start. The validation strategy shapes the design, and evidence is produced as the work is done.
What We Do
Computer system validation and computer software assurance
Risk-based CSV and CSA in line with GAMP 5 (Second Edition): validation plans, specifications, test protocols and reports.
Data integrity
Assessments and remediation against ALCOA+ principles, including audit trail review and access control.
• Part 11 and Annex 11 readiness
Gap assessments of existing systems with practical remediation plans.
Commissioning & qualification
IQ, OQ and PQ for automated equipment and systems.
Validation lifecycle support
Change control, periodic review, and upgrades and migrations that maintain the validated state.
Who It's For
QA and QC heads, validation managers and CSV leads. Also project and engineering leaders who need validation to keep up with delivery.
Our Approach
Assess
System inventory, GxP impact and risk assessment.
Outcome: validation effort focused where risk is highest.
Design
Validation strategy and plan agreed with quality.
Outcome: no surprises at the end of the project.
Deliver
Specifications and test protocols written alongside the build.
Outcome: evidence produced as the work is done.
Validate
Test execution, deviation management and summary reports.
Outcome: systems released for GxP use.
Support
Periodic review and change control.
Outcome: the validated state maintained through the system lifecycle.
Our Technologies & Partners
Tursted across regulated manufacturing
works across a broad range of industrial automation platforms and technologies, including:
Compliance & Validation
Réalta Technologies supports delivery within:
- GAMP 5 (Second Edition)
- FDA Computer Software Assurance guidance
- 21 CFR Part 11
- EU GMP Annex 11
- ALCOA+
- ISO 13485 and 21 CFR Part 820 for medical devices and HACCP for food
Compliance is integrated into our delivery approach, not treated as a separate exercise after implementation.
Insights and Perspectives
Ideas for more connected
manufacturing
Technical insight, practical guidance and real-world thinking from Réalta specialists.
REALTED CASE STUDIES
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COMPLIANCE, VALIDATION & QUALITY
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