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A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report.
SAP is the acronym for Systems Applications Products. It is a system that provides users with a soft [ambiguous] real-time business application. It contains a user interface and is considered very flexible. In an SAP audit, the two main areas of concern are security and data integrity.
product certifications (many nations) Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
Accreditation is a specific organization's process of certification. According to the U.S. National Council on Measurement in Education , a certification test is a credentialing test used to determine whether individuals are knowledgeable enough in a given occupational area to be labeled "competent to practice" in that area.
An engineering verification test (EVT) is performed on first engineering prototypes, to ensure that the basic unit performs to design goals and specifications. [1] Verification ensures that designs meets requirements and specification while validation ensures that created entity meets the user needs and objectives.
Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [ 1 ]
SAP Exchange Infrastructure (XI) (From release 7.0 onwards, SAP XI has been renamed as SAP Process Integration (SAP PI)) SAP Extended Warehouse Management (EWM) SAP FICO; SAP BPC (Business Planning and Consolidation, formerly OutlookSoft) SAP GRC (Governance, Risk and Compliance) SAP EHSM (Environment Health & Safety Management)