CSV

AR Technologies & Automation provides you full length of following service but it`s not limited to :

CSV Validation Services:

• PLC-HMI / IPC, SCADA, DCS System Validation

• Building Management System (BMS) & EMS Sytem Validation

• Analytic Software VAlidation like SAS, WinNonlin, Chromeleon

• Laboratory Software System such as HPLC, GC, LCMS

• Plant Serialization / Aggregation, TracLINK, Track and Trace, Warehouse Management Software Validation

• LIMS, Empower and Metlab, Speciality Software Validation

• IT Infrastructure, Server and Network Validation

• GAP Assessment and 21 CFR, Part 11, GxP Assessment

• Excel Sheet Developments and Validation as per 21 CFR, Part 11

• CSV Documents Reviewer, CSV Audit, Audit Support

• Data Integrity, ALCOA. Risk Assessment & CSV Training

Computer Systems facilitate the daily work of Life Sciences manufacuturers. Computers are found more and more in research and development departments, in manufacturing sites, and in storage and distribution and quality control areas. They create, modify, maintain, archive, retrieve or transmit data.

Computer Systems are a central factor determining work sequences; they are faster and less expensive than manual interventions.

Where a Computer replaces a manual operation, there should be no resultant decrease in product quality or quality assurance.

Key Challenges

Any computerized system that could influence  the safety and quality of pharmaceutical products must be validated.                                                       A Validation program must verify whether

• The computer and its applications work as intended and according to specifications and regulatory requirements.

• The computer data is protected from unauthorized access and changes, as well as unintended loses.

• The quality management system works in sync with the computerized systems with regard to the good practices.

Comprehensive Validation Assistant

We focus on implementing internationally accepted GAMP 5 guidelines and its current interpretations for validation of computerized systems applying Risk Based Approach and Life Cycle Management Philosophy.

Our Validation Program covers:

• Validation Master Plan

• Risk Assessment Plan and Report

• User Requirement Specifications

• Functional Specifications

• Design Specifications

• Infrastructure Qualification and Report

• Installation Qualification Protocol and Report

• Operational Qualification Protocol and Report

• Performance Qualification Protocol and Report

• Validation Summary Report

• Traceability Matrix

• Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11)

• Supplier Assessment Report

• Periodic Review Report