Medical Devices, pharmaceutical and life sciences industries
Medical device manufacturers, Biotech and Pharmaceutical companies must be meticulous in their development process and undergo strenuous verification. QualiTest has created a wide range of consulting services using a team of domain experts, to deliver high quality solutions for these industries:
- Validation and Verification Services V&V
- System classification analysis
- FDA & CE Mark compliance roadmap and analysis (510K, PMA…)
- Computerized systems Gap Analysis
- Validation Master Plan (VMP) & Computer Validation Master Plan (cVMP) preparation
- Validation Protocols preparation & execution
- 21 CFR Part 11 Risk Assessment, Gap Analysis, developing SOPs and test documents
- IQ/OQ/PQ
- Development of Standard Operating Procedures (SOPs)
- cGMP/GAMP
- Product and equipment risk assessment
- Validation & Verification of Processes & Equipment Required By HACCP
- Product and product-line equipment Risk Assessment
- Construction of Pharmaceutical, Biotechnology Facilities Design Review
Test Process Improvement
Test Process Improvement (TPI) is a structured assessment of an organization's testing maturity targeted at improving its overall testing and QA processes. It allows you to evaluate your current QA and testing processes according to 20 Key Areas and offers insight into defining gradual and controllable steps for improvement.
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Onshore Testing Outsourcing
QualiTest Onshore managed services provides you with the best professional testing and QA solution tailored according to your needs while taking full responsibility for your testing process. Our solution includes QualiTest’s own Rapid Software Testing (RST) methodology which is designed to conduct first-class QA and software testing in a reality of an environment with limited resources, evolving requirements, increased complexity and growing quality needs.
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QA and testing staffing
QualiTest’s Flexible Staffing solutions provide great testing professionals at a very competitive price. QualiTest has an extensive pool of domain experts in various disciplines. This enables you to ramp up quickly and complete your projects even if your organization does not have the staff or knowledge to do so.
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QualiTest Tools
QualiTest has developed testing tools based on industry needs and requirements. These tools can make the test process more efficient and save you money.
Validation Management Tool – VMT is a web (SaaS based) tool which will help you manage every step of product validation – from product feature specification, to planning, scheduling and executing tests.
Read more about Validation Management Tool Automation Planner – A suite of tools that enables every tester to design, manage and conduct test automation, with no coding knowledge.
Read more about the Automation Planner FUNTASY - A testing tool for non-GUI API test automation based on the Keyword Driven Testing (KDT) approach. FUNTASY can help improveproduct quality while reducing by over 80% the cost of development, maintenance and execution of automated testing.
Read more about FUNTASY