400 Kalaf St. Box 31 San Juan, PR 0072 * phone: (787) 886-3863 * fax: (787) 886-3862 * email: email@example.com * Copyright © 2015 GVS, INC. All rights reserved.
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QA/QC and Compliance Support
Support during FDA Inspection
Responding to FDA Citations
Laboratory Investigations and Out of Specification Evaluations (OOS)
Implementation of Compliance Programs
Analytical Method Transfers and Laboratory Support
Controlled Drug Substance Programs under the DEA Laws and Regulations
Computer Systems Validation Life Cycle
Technology Transfers and New Product Introductions
Manufacturing Process Support
Factory Acceptance Tests (FAT)
Equipment Qualification (IQ/OQ/PQ)
Utilities Systems and Facilities Qualification
Master Plans and Technical Documentation
CAPA and Non Conformance Reports
We offer our services in a timely manner, with the quality required and within the established budget. We are able to achieve this through continuous training and development of our specialists, creating a cost effective service for our clients’ industry partners.
GVS-Inc. is a full service professional company which offers consulting services that include:
Our Validation experience (equipment/systems/utilities/facilities) covers from master planning and project management to the development and field execution of IQ, OQ, and PQ protocols. GVS, Inc. has extensive experience preparing final validation reports and validation packages for each protocol executed during the validation activities.
We offer an exceptional level of experience in the critical area of Computer System Validation (CSV). Our experience in CSV covers from prospective and concurrent validations, 21 CFR Part 11 Gap Analysis and Audits, Electronic Records/Electronic Signature Assessments, acceptance testing protocols (IOP/Q) development and execution, and maintenance activities (change control, security, backup and recovery, data storage, periodic system reviews, and documentation).
As part of the Process Automation Cycle, our experience includes controls, instruments, and system integration. GVS personnel have proven validation experience of the process automation cycle, such as: Start-Up and Commissioning, Design and Functional Specifications (P&ID’s, Wiring, Loop Diagrams, I/O Connections, and Point to Point), PLC programming and SCADA (Control View, Allen Bradley, Wonderware, and RSView), and Process Improvements Implementations.
As part of the Quality Assurance expertise, GVS, Inc. offer to our customers the opportunity to be supported by professionals with Food and Drug Administration background. These professionals could assist our projects, provide support during FDA or any regulatory agency inspection and audit customer documentation to provide assurance and fully compliance on the relevance of international policies and/or FDA regulations.