Regulations have imposed software testing and Quality Assurance onto the Life Sciences sector, effecting medical devices producers, biotechnology companies, pharmaceutical R&D and manufacturing companies.
QualiTest offers its expertise in QA, Computerized Systems Validation and Software Testing for clients in the Pharmaceutical, Biotech and Medical devices industries. QualiTest has developed methodologies for auditing, verification and validation of software systems developed in-house, customized adjusted or purchased as a package. Methodologies comply with the GMP (Good Manufacturing Practice) requirements of the FDA organization and passed many internal and agency audits.
Why QualiTest?
QualiTest offers a full solution that includes all the quality components required for full validation of the GMP standard. QualiTest approach is to find the most efficient, cost effective and complete solutions by using a combination of guidelines and standard implementations, QualiTest creative technical knowledge and the client's policy and limitations.
QualiTest Services for the HealthCare and Life Sciences industry:
- Consulting services
- Performing computerized systems Gap Analysis
- System classification and deliverables determination
- Product and equipment risk assessment
- FDA Validation
- Performance of cGMP/GAMP
- Preparation of Validation Master Plan (VMP) & Computer Validation Master Plan (cVMP)
- Preparation of Computer Validation Protocols including execution
- Performing 21 CFR Part 11 Risk Assessment and Gap Analysis, Assessing and developing SOPs and test documents
- Preparation of Validation Protocols including execution (IQ/OQ/PQ)
- Development of Standard Operating Procedures (SOPs)
- Design Review of Construction & Critical Systems
- Verification & Validation of Processes & Equipment Required By HACCP
- Product and product line equipment Risk Assessment
- Design Review of Construction of Pharmaceutical, Biotechnology Facilities
- Review of Engineering Files, Basis of Design