Quality Assurance Services
Quality Systems implemented at VelaLabs
At VelaLabs, we are committed to the highest international quality standards. Our Quality Assurance approach ensures that every process meets the highest standards. This creates smoother processes, stronger outcomes, and an exceptional experience for customers.
We design efficient and future‑ready quality systems that strengthen collaboration and continuously elevate performance. By applying Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Laboratory Practice, we ensure scientific integrity and patient safety.
- Good Manufacturing Practice: GMP according to local (Austrian and EU) legislation but also according to CFR is implemented in several internal processes.
Starting off in 2006, VelaLabs received the first GMP certificate (EMA) in early 2007 keeping up the certified state since then. Find our latest GMP certificate here! - Good Laboratory Practice: GLP according to local and international legislation is implemented in several internal processes.
Starting off in 2020 VelaLabs received the first GLP certificate (EMA) and keeps up the certified state since then. Find our latest GLP certificate here! - Good Clinical Laboratory Practice: VelaLabs is following the international guidelines for analyzing clinical trial samples. The respective quality procedures like in-study audits and data audits are implemented within several internal standard operating procedures.
In 2024 we have expanded our Manufacturing and Importation Authorisation (MIA) and GMP certification. We offer Qualified Person (QP) certification and batch release capabilities for both Investigational Medicinal Products (IMPs) for clinical trials and medicinal products for human or veterinary use that hold a marketing authorisation (MA) or are made for export. The scope of this expansion also includes the importation and batch release of investigational and authorised medicinal products for EU entry.
We are fully equipped to manage product release not only within the European Union but also for UK or markets falling under a Mutual Recognition Agreement (MRA) e.g. USA, Japan, Israel.
Furthermore, we offer re-testing and confirmatory laboratory services for manufacturers outside of the EU/MRA regions, ensuring that their products meet the stringent standards required for batch release.
Our QA Operations
Quality Assurance (QA) plays a vital role at VelaLabs in ensuring that analytical services, and processes meet defined quality standards.
Key responsibilities include
- developing and maintaining quality frame work inside the company,
- establishing processes
- review and release quality relevant documentation
- conducting audits to verify compliance
- identifying opportunities for continuous improvement
Our QA team ...
- maintains the oversight of deviation handling
- supports change control implementation
- supports risk management by analyzing defects and root causes
- ensuring corrective and preventive actions are implemented effectively.
Additionally, we collaborate closely with several teams and departments at VelaLabs to ensure data integrity and consistent, reliable outcomes across the organization.
Our QA Team
VelaLabs’ Quality Assurance is structured into two specialized teams, working together to uphold the highest standards in all processes.
Quality Systems Team
This team is responsible for overarching quality systems and procedures, including:
- Change control management
- Risk management
- Equipment qualification
- Computer System Validation (CSV)
- Data integrity and audit trail reviews
- IT infrastructure qualification
- Supplier qualification
Quality Operations Team
The Quality Operations Team supports all analytical activities — from assay development through validation, and across the entire sample workflow: sample receipt, testing, and reporting. The team also conducts batch record review in close collaboration with our Qualified Persons (QP).
Our Commitment
With a highly motivated and skilled team, we ensure comprehensive quality oversight across all procedures performed at VelaLabs. Transparent communication and reliability form the foundation of our partnership with clients and collaborators.
Our QA Missions and Your Benefit
We follow a simple principle: quality is not an act — it's a commitment.
Our Quality Assurance mission is to create products, services, and processes that deliver reliability, trust, and lasting value. We embed quality into every phase of the journey, ensuring that our customers experience excellence from the very first interaction.
The Benefits of Quality Assurance
Exceptional Customer Satisfaction
- Consistent quality leads to trust, loyalty, and a superior user experience.
Reduced Risks & Lower Costs
- Preventing issues early saves time, minimizes rework, and protects your business.
Streamlined & Efficient Processes
- Clear standards and optimized workflows boost productivity and reduce waste.
Guaranteed Compliance
- We ensure all processes meet regulatory and industry requirements—every time.
Empowered, High‑Performing Teams
- With strong QA practices, teams work smarter and deliver better results.
Long‑Term Business Success
- Quality drives competitiveness, innovation, and sustainable growth.