During a Validation Periodic Review project, our Validation Engineers will identify deficiencies or gaps in the validation lifecycle, develop remediation plans to remediate the process and equipment validation deficiencies identified, and ensuring that all remediation activities are completed as scheduled in the remediation schedule. Review or author routine re-validation protocols and reports.
Once we have executive buy-in, we oversee the implementation process from start to finish.
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Qualitech Validation & Compliance Solutions
Our professionals are for the most part, Validation Engineers whose duties include but not limited to test protocol generation and execution, establishing validation standards, generating other validation documents such as Validation Master Plan (VMP), User requirement Specification (URS) executed test protocol report generation & execution for equipment, facility, utility, processes as well as document test results and maintain records for later analysis. Our Validation Engineers also have the experience to coordinate with other personnel, departments, system owners and subject matter experts who will be affected by testing.
Our Validation engineers are very proficient in final reports generation and making adjustments to equipment, facility, utility or processes as may be required due to non-conformances and subsequent corrective & preventative actions.
Qualitech Validation & Compliance Solutions, LLC (QVC) is a GxP (GMP, GLP and GCP) consulting company specializing in the Validation/Qualification of Processes, Equipment, Facilities and Utilities in the Medical Device, Biotechnology and pharmaceutical industries ensuring regulatory compliance.
The first step for Qualitech Validation & Compliance is to meet with the client to define their needs. These steps will help Qualitech
Engineers to define the work that needs to be done or the project scope is defined. Once this is defined, the project manager will be able to allocate tasks and give his team the direction they need to deliver the project on time and within budget.
OUR SERVICES
TESTIMONIALS
Project PLANNING & resources
PERIODIC VALIDATION REVIEW:
Project Scope Determination
A clear definition of the project scope is the foundation toward establishing a project timeline, setting of project goals and allocating project resources.
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- Validation Document Generation
- Commissioning
- Qualification
- Validation
- Periodic Validation Review
- FDA 483 Citations
- FMEA and CAPA Methods
- Change Control
Qualitech Validation & Compliance monitors Key Performance Indicators at 3-week intervals, adjusting strategies as needed.
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“Qualitech Validation & Compliance delivered everything they promised timely and within budget. Our customer satisfaction level for Qualitech is at an all-time high!”