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Consulting - Qualification & Validation
Aveta’s validation services encompass all aspects of product, process, cleaning, method & packaging validation required in the regulated life-science industries. Our approach to developing, implementing & administrating a validation program begins by setting out a clear hierarchy between policies, procedures & protocols, to design a program that is effective, supportable & manageable. Aveta can assist your company with process validation, provide a turn-key solution for initial validation in preparation for pre-approval inspections or provide revalidation services.
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Validation Development & Documentation
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Risk Based Validation |
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Development & or assistance for characterization documentation inclusive of: BOD & DQ; MVPs; URS, FRS, DDS, Commissioning Plans, FAT/SAT plans; IQ, OQ, PQ, and PV |
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Facility Validation
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Design Qualification (DQ) |
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Basis of Design (BOD) |
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Master Validation Plans |
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Utility Validation
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Water: RODI, WFI, Plant Steam, Clean Steam |
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Gasses: LN2; Medical O2, N2; CDA; CCA |
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HVAC, Environmental Monitoring, back-up power, etc |
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Process Equipment Validation
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Biotech, Pharma, Parenteral & Medical Devices |
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Automation & P.A.T. |
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GLP & GMP Lab Equipment |
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Cleaning Validation
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Development of cleaning studies & validation protocols for equipment, change over & line clearance |
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Development of cleaning studies & validation for Multi-use / Multi-product environments |
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Process Validation
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Process: Mapping & development of process flows, master batch records, unit operation batch records, SOP’s and risk based characterization studies |
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Validation: Development of VMP’s, Quality Lot management and protocols for execution |
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Process Validation around P.A.T. implementation |
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Analytical Methods
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Methods Validation for Cleaning, Products & P.A.T. |
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Computer & System Validation
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Development of plan to get to Part 11 & risk based compliance |
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System integration validation from ERP to shop floor |
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Development of integrated approach to P.A.T. |
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