| Testing Services |
| QualiMED - FDA validation |
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| QualiMED |
QualiMED:
Qualitest services for Biotech, Pharmaceutical and Medical
devices companies
QualiMED services include:
Consulting services: Qualitest has broad consulting
experience for medical devices/Biotech firms.
This Service includes:
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Performing
computerized systems Gap Analysis |
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System classification
and deliverables determination |
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Product
and equipment risk assessment |
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FDA Validation |
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Performance
of cGMP/GAMP
- Documents & Procedures
- Sub-Contractors & Suppliers |
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cGMP & Computer
Validation Training |
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Preparation
of Validation Master Plan (VMP) & Computer Validation
Master Plan (cVMP) |
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Preparation
of Computer Validation Protocols including execution
- Software Packages (DCS, SCADA,
LIMS, ERP/MRP)
- Custom Built Systems
- PLCs |
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Performing
21 CFR Part 11 Risk Assessment and Gap Analysis,
Assessing and developing 21 CFR Part 11 SOPs and
test documents |
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Preparation
of Validation Protocols including execution (IQ/OQ/PQ)
- Equipment Validation
- Critical System Validation
- Process Validation |
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Development
of Standard Operating Procedures (SOPs)
- Maintenance Procedures
- Production/Quality Assurance
SOP's |
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Design Review
of Construction & Critical Systems |
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Verification
& Validation of Processes & Equipment Required By
HACCP |
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Product and
product line equipment Risk Assessment |
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Design Review
of Construction of Pharmaceutical, Biotechnology
Facilities
- Specialty Clean Rooms
- Construction details
- Highly cleanable room finishes,
installations & fittings
- HVAC Systems - Aseptic Environment:
Temperature, Relative Humidity, Differential air
pressure requirements, Control as well as monitoring.
- Critical Systems- WFI, PUW,
Pure Steam, Oil Free Compressed Air, Gases, CIP.
& SIP. |
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Review of
Engineering Files, Basis of Design for:
- Facility
- Critical Systems
- Critical Equipment
- Sterilizers
- Computerized Programs |
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| What
is it? |
| 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 have passed many internal and agency audits.
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| Why
Qualitest? |
| Qualitest offer
full solutions that includes all the quality components
required for full validation of the GMP standard. Qualitest's
approach is to find the most efficient, cost effective
and complete solutions by using a combination of guidelines
and standard implementations, Qualitest's creative technical
knowledge and the client's policy and limitations |
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Customers |
| BioTechnology
General, Johnson&Johnson (Biosense), Oridion, Mazor, Medivision,
Medcon, IMT, SuperDimension and many more… |
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