Validation is to verify that all aspects of a system specific to an automated control system and application specific source code are satisfactorily tested, and meet defined acceptance criteria. Computer System Validation is an integral part of A M P S I. It has a full-time staff dedicated to computer validation. We have validated laboratory, toxicology, HPLC, LIMS, adverse event reporting, clinical, statistical, manufacturing, distribution, and custom system. A M P S I provides validation services for all types of standard and custom computer systems, including automated and semi-automated processes controlled by a DCS (Distributed Control System), PLC (Programmable Logic Controller), and similar computer systems.  With the FDA's new Part 11 ruling, it is critically important to insure your system has been properly validated. 

• Method Validation (Licensed and clinical products)

• Cleaning Validation (Water testing-TOC, LAL, Sterility testing)

• Systems/ Equipment Qualification

• Computer Validation (CFR Part 11) for QC Lab Equipment Software's, Processes Equipment software)

• Process Validation

• GMP Audits

• Writing SOPs, Protocols, Reports, and implementing IQ/OQ/PQ’s

A M P S I also carry out vendor audits of developers of software to determine compliance to the GMP, GLP, GCP, 510(K), NCCLS, CLIA, GAMP and international standards such as ISO 9000, IEEE, and ANSI. An integral part of the overall validation effort involves qualification studies for the computer hardware/software controlling and/or monitoring utility systems and process equipment as well as information systems. We have a specialized Computer Validation Team to meet your system, network and workstation validation needs. When you install a new computerized system we will supervise the installation of the computer system and prepare the installation, operational and performance qualification protocols, as specified in the Validation Master Plan. Our process consists of validating the equipment, hardware, and software as one unit. We can assist with project planning, system design requirement analysis, configuration, data issues and system retirement.

For higher level systems such as client-server systems, we will develop IQ, OQ, and PQ protocols, and ensure compliance to FDA 21CFR Part 11.  We will tailor our solutions to your individual validation needs with today’s rapidly evolving technology. The protocols (IQs, OQs, PQs) that are developed for each system are defined in a pre-agreed list of deliverables. A M P S I will use the the Client Master Plan and SOPs to develop the tests and acceptance criteria that are required for each system. Automation validation is usually included in the protocol covering the system that the automation controls. Initial test requirements will come from the master plan and A M P S I’s own validation guidelines.