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		<p style="font-size:9px; color:#BBBBBB">Pharma Group Baltic OÜ<br>
			Parda 8, büroo 52<br>
			10151, Tallinn, Estonia<br>
			+372 611 60 25<br>
			+372 580 500 39<br>
			<A href="mailto:in@pharmagroup.ee">in@pharmagroup.ee</a><br>
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						<font size=6 color=#100080><b>Computer Validation</b></font><BR><BR>		
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						Computerized systems that are used in the production of finished pharmaceuticals and/or active pharmaceutical ingredients strongly contribute to product quality and consistent performance of production facility substantially eliminating manual labor and risks related to the “human factor”. At the same time the high level of complexity of such systems may by itself pose risks for product quality and safety, which is connected to possible faults in the design, installation/programming, operation, maintenance and retirement of computerized systems.
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						It is therefore required that a risk-based approach to computerized systems is applied and corresponding life-cycle activities are incorporated into the pharmaceutical manufacturers Quality Management System (QMS) inline with Good Automated Manufacturing Practice (GAMP 5) guidelines. The term Computer Validation is used both as a general concept to address the whole life-cycle of a computerized system in accordance to GAMP 5 / 21 CFR Part 11, as well as for the actual validation activities that are the part of the systems life cycle. 
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						<B>Pharma Group Baltic</B> has IT and automation specialists experienced in GMP/GAMP and a number of successfully accomplished computer validation projects. 
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						We can offer to our Clients a wide range of services/activities related to a computerized system life cycle / computer validation:     
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						<B>Planning and QMS documentation</B>
						<ul>
							<img src=bullet.png>Development of policy and general procedures (in respect to computerized systems):</img>
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								<br>Development of policy
								<br>Distribution of roles and responsibilities (SOP)
								<br>Training (SOP)
								<br>Supplier management (SOP)
								<br>Creating / maintaining registry of systems (SOP)
								<br>General planning of validation (SOP)
								<br>Planning of monitoring / improvement (SOP)
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							<p><img src=bullet.png>Identification of compliance standards</img>
							<p><img src=bullet.png>Identification of system</img>
							<p><img src=bullet.png>Identification of key personals</img>
							<p><img src=bullet.png>Composing URS</img>
							<p><img src=bullet.png>Development of compliance achievement strategy:</img>
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								Risk Assessment
								<br>System Components Categories Assessment
								<br>Hardware / Software Suppliers Assessment
								<br>Determination of System Life-Cycle Strategy
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							<p><img src=bullet.png>Work Plan:</img>
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								Project realization plan
								<br>Computer validation plan
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							<p><img src=bullet.png>System specification:</img>
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								Functional Specification (FS)
								<br>Configurational Specification
								<br>Design Specification (DS)
								<br>Design Review and Approval
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							<p><img src=bullet.png>Development of procedures for operation:</img>
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								Handover of the system (SOP)
								<br>Implementation of system maintenance and monitoring (SOP)
								<br>Corrective and preventive measures (SOP)
								<br>Change management (SOP)
								<br>Audit (SOP)
								<br>Backup / restore (SOP)
								<br>System safety (SOP)
								<br>Record management (SOP)
								<br>System retirement (SOP)
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						<B>Realization and testing (computer validation)</B>
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							<img src=bullet.png>Purchasing / installation of hardware:</img>
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								<br>Purchasing
								<br>Installation
								<br>IQ
								<br>Standard Firmware modification / control
							</ul>
							<p><img src=bullet.png>Purchasing / installation of standard software:</img>
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								Operational System
								<br>Standard program package
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							<p><img src=bullet.png>Development and review of program code:</img>
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								Development of strategy and principles
								<br>Identification of software modules
								<br>Development of software modules specifications (MS)
								<br>Development of modules code
								<br>De-bugging / cleaning module code
								<br>Creating reference tables
								<br>Program code review
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							<p><img src=bullet.png>Development of testing documentation:</img>
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								Testing plan / strategy
								<br>Testing protocols / specifications
								<br>Testing descriptions / scripts</ul>
								<p><img src=bullet.png>System testing:</img>
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								Modules testing (MS)
								<br>Integration testing (DS)
								<br>Functional testing (FS)
								<br>Performance testing (URS)
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							<p><img src=bullet.png>Development of reports and release of the system:</img>
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								Testing reports
								<br>Summary testing report
								<br>Summary computer validation report
							</ul>
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						These services/activities can be realized with a different degree of participation of <B>Pharma Group Baltic</B> specialists, from conceptual assistance and consulting to full execution of work. Optimal division of responsibility is determined individually for each project.
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