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Qualitech Validation & Compliance Solutions

Qualitech Services:

1. Project Planning and Scheduling
   
2. Equipment and Facility Commissioning
   
3. Technical Training for cGMP Production
   
4. Process Validation
   
5. Qualification of Facility, Utility, and Equipment, operation and maintenance
   
6. Technical Transfer to cGMP Operations
   
7. Risk analysis generation
   
8. Qualification of a process development scaled down production model
   
9. Characterization Studies
   
10. Product/Buffer/Medium Hold Times
    
11. Materials Qualification
    
12. Leachable / Extractable
    
13. Container Closure
    
14. Facility Cleaning
    
15. Equipment Cleaning
    
16. Filter Integrity
    

• Preparing and executing validation documents.  
  
• Project execution for multiple systems validation.
  
• Understanding the hours budgeted for completion of each task on a specific.
• Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers.
• Develop Installation, Operational and simple Performance qualification documents.
  

Qualitech Validation & Compliance Solutions, LLC

Qualitech Validation & Compliance Solutions, LLC (QVCS), is a very reputable consulting company with highly trained, experienced and dedicated team of professionals based in Houston Texas. Our team of consultants are experienced in providing validation and compliance services to FDA regulated industries such as, Medical Device, Bio-Technology and Pharmaceutical companies across the US.

Qualitech Validation & Compliance Solution's highly trained engineers and professionals are experienced and knowledgeable to provide high quality validation & compliance services as follows:

1. Commissioning  (Facility, Equipment, Computerized systems etc.)
   
2. Qualification
   
3. Validation (Equipment, Automated Systems, Manufacturing Processes, Cleaning Processes, Method etc.) 
   
4. Quality Systems
   
5. Periodic Validation Review (PVR)
   
6. FDA 483 citations.
   
7. Generation and Execution of Validation documents such as:
   

• Master Validation Plan (MVP), User Requirement Specification (URS), Design Qualification (DQ), Traceability Matrix (TM), Commissioning Protocols (COMM), Installation Qualification Protocols (IQ), Operational Qualification Protocols (OQ), Performance Qualification Protocols (PQ), Design Specification (DS), Process Validation (PV), Methods Validation, Electronic Records/Electronic signatures (ERES) Assessments, Final Reports, SOPs, Gap Analysis, Periodic Validation Review (PVR) etc.)
  

We provide a wide range of services with our experienced team of professionals each of whom have years of experience as a Sr. Validation Engineers, Project Managers and GMP, GLP and GCP (GxP) Consultants in the Medical Device, Biotechnology and Pharmaceutical and would love an opportunity to assist your company with any issue you may be facing.

At Qualitech Validation & Compliance Solutions, we keep up with all current trends of regulatory practices to ensure that all your project needs and expectations are met.

Please contact us at info@qualitechinc.com for a free quote or to receive your free brochure.