Qualitech Validation & Compliance Solutions

Free Support

SERVICES

Our flexibility and project experiences range from the qualification of newly constructed facility and/or renovated facility. Our Engineers in conjunction with the client will put together a well planned, documented, and managed engineering approach to the startup and turnover of new or modified facilities, systems, and equipment to the client that results in a safe and functional environment that meets established design requirements and customer expectations.

Our Engineers perform Commissioning projects under Good Engineering Practice (GEP) which is defined as: “Proven, accepted methods that ensure that engineering solutions meet end-user / customer requirements, are cost-effective, compliant with current regulations, and are well documented".

Commissioning SERVICES

EQUIPMENT QUALIFICATION

QUALIFICATION & VALIDATION

PERIODIC VALIDATION REVIEW (PVR)

Facilities, systems, equipment and processes, including cleaning, should be periodically evaluated to confirm that they remain valid. Where no significant changes have been made to the validated status, a review with evidence that facilities, systems, equipment and processes meet the prescribed requirements fulfills the need for revalidation.

Qualitech Validation & Compliance Solutions, LLC Engineers and Consultants have the experience in the generation, routing for approval and execution of:

Project Management
Validation Master Plan (VMP)
Validation Plan for any system (VP)
User Requirement Specification (URS)
Design Reviews (DR)
Design Qualification (DQ)
Reviewing Functional Requirement Specifications (FRS)
Trace Matrix (TM)
Installation Qualification Protocol (IQ)
Operational Qualification Protocol (OQ)
Performance Qualification Protocol (PQ)
Criticality and Impact Assessment
Risk Assessment and Mitigation
Change Management
Cleaning Validation
Sterilization Validation
Process Validation
Computer Software Validation
Protocol Generation and Execution ■ Installation Verification and Qualification ■ Operational Verification and Qualification ■ Performance Verification and Qualification
Final Reporting
Change Control
Aseptic Processing
Disposable Single-Use Technology
Upstream and Downstream Processing
Cleanroom Qualification
Process, Utility and Facility Support Systems
Sterilization Process Validation
CIP, COP & SIP

Our Engineers and Consultants are very Professional and provide these services and solutions across the Medical Device, Bio-technology and Pharmaceutical industries.

As needed, Risk Management Tools are utilized to ensure the safety and to minimize any potential Risks to consumers.

EQUIPMENT

Qualitech Validation & Compliance Solutions, LLC is a reputable company, with experienced Engineers and Consultants that have the expertise, training and ethics to generate and execute commissioning protocols for single equipment to a complex system of equipment. As a company, It is customary and a tradition that our experienced Validation Engineers and Consultants strive to meet the client's project goals and objectives. We also understand the importance to meet these goals and objectives within the organizational standards and FDA regulatory standards (GxP). Our Engineers and Consultants perform their duties in the most efficient and strategic way to meet the expectations of our clients timely and within budget.

+1.2818275401

FACILITY

Our Computerized Systems Validation (CSV) professionals will generate, execute and document the validation of software systems as per the approved requirements and develop validation documents to ensure that the validated state is continuously maintained throughout the lifecycle of the validated computer system.

COMPUTERIZED SYSTEM VALIDATION