Pharma & Biotech Software Testing & QA Services
Ensure Regulatory Compliance and Data Integrity with Specialized QA Solutions
As pharmaceutical and biotech companies accelerate innovation, they must navigate strict regulatory environments and manage sensitive patient and research data. In this high-stakes industry, software failures can delay approvals, damage reputations, or even endanger lives. CelticQA delivers specialized software quality assurance and testing services tailored to the unique demands of pharma and biotech organizations.
Our services support every stage of the product lifecycle—from R&D platforms to clinical trial systems to manufacturing automation—ensuring software reliability, regulatory compliance, and secure data handling.
Why QA Testing Matters in Pharma & Biotech
Pharma and biotech companies increasingly rely on complex software to manage discovery, development, clinical trials, regulatory submissions, and manufacturing. QA testing ensures these systems are:
- Accurate and Reliable – Critical for data integrity and outcome validity
- Compliant – Supports HIPAA, GDPR, 21 CFR Part 11, GxP, and FDA requirements
- Integrated and Scalable – Enables seamless data flow across research and operational systems
- Validated and Verified – Confirms that systems meet design and user requirements
Robust QA reduces risk, accelerates time to market, and builds confidence in software used to power lifesaving treatments.
Regulatory and Compliance Considerations
CelticQA helps pharma and biotech companies meet stringent regulatory standards by embedding compliance into every stage of QA:
- GxP (Good Practice Guidelines)
- 21 CFR Part 11 – Electronic records and electronic signatures
- FDA CGMP & GCP – For manufacturing and clinical trials
- EMA, MHRA, and other global authorities
- HIPAA, GDPR, and other data protection frameworks
We provide validation documentation, traceability, and audit support to keep you inspection-ready.
QA Challenges in the Pharma & Biotech Industry
Pharma and biotech firms face several industry-specific QA hurdles:
Regulatory Complexity
Ongoing changes from agencies like the FDA and EMA demand continuous compliance updates.
System Integration
Legacy lab systems, cloud platforms, and third-party tools must seamlessly connect and communicate without data loss.
Sensitive Data Protection
Patient and research data must be kept secure and private at all times, requiring airtight security and encryption protocols.
Critical Testing Scenarios
Pharma systems must be tested across a broad range of functional and non-functional requirements, including performance, stress, and failover testing. CelticQA's industry-aware QA teams have the tools, methods, and expertise to address these challenges efficiently.
QA & Testing Solutions for Pharma and Biotech
CelticQA offers a comprehensive suite of QA services tailored to support drug discovery, clinical trial platforms, lab systems, and manufacturing execution software:
Automated Testing
Regression Testing
Verification & Validation
Compliance & Validation Support
Integration & End-to-End Testing
Performance & Stress Testing
Why Choose CelticQA?
With over decades of experience and clients across the US, Ireland, and the UK, CelticQA is a trusted partner for pharma and biotech leaders like Illumina and Sartorius Stedim Bio. Our strengths include:
- Deep industry knowledge in regulated environments
- Proven frameworks for fast onboarding and scalable execution
- Real-time dashboards and reporting for visibility and control
- Dedicated QA consultants who integrate seamlessly with your teams
We tailor every engagement to your systems, timelines, and regulatory needs.
Our Automation Tool Capabilities
USA
Experience quality assurance with our expert QA Testing Services in the USA.
UK
Elevate your software quality with our tailored Software QA Testing Services in the UK.
Ireland
Quality assurance for your software made easy with our experienced Software QA & Testing Services in Ireland.
Our Key Clients
Partner With CelticQA
CelticQA is your trusted partner in delivering safe, compliant, and high-performing software solutions to support groundbreaking scientific innovation.
Atlanta, USA
MON – FRI: 9 AM to 5 PM
Dundalk, Ireland
MON – FRI: 9 AM to 5 PM