Manufacturing resources planning

Configurable application software usually includes custom configurable packages such as Manufacturing Resource Planning (MRP 11), Documentum , Maximo and so on. Validation of such systems requires an audit of the supplier and validation of any bespoke application software. 

These activities and their documentation represent a principle only and may he either combined (e.g., for a small spreadsheet maao application) or further subdivided according to the complexity of a specific IT system (e.g., for an MRP II [Manufacturing Resource Planning] system). Different parties (internai or external) may carry out these activities. 

Validating Enterprise/Manufacturing Resource Planning Systems... 

Examples of FDA 483s for Manufacturing Resource Planning (MRP II) systems illustrate the fact that, in many cases, the same types of deficiencies are being found in 1998 as found in the early 1990s. A 483 from a 1993 inspection cited inadequate detail in the software specifications. A 483 issued... 

Integration of the LIMS with other systems (e.g., MRP II [Manufacturing Resource Planning] systems, typically via a LAN or wide area networks [WAN]). 

The basic validation approach is no different from that applied to other information management systems, such as a Manufacturing Resource Planning (MRPll) system or a Laboratory Information Management System (LIMS). An approach based on the validation life cycle in GAMP [4] is appropriate. Figure 10.3 shows how validation documentation relates to the project activities. 

VMS = Virtual Memory System LIMS = Laboratory Information Management System EDMS = Electronic Document Management System MRP II = Manufacturing Resource Planning DBMS = Database Management System ... 

MRP II (Manufacturing Resource Planning) before joining HMR s IT function 6 years ago. Previously, he spent 4 years developing control software on data network communication systems for NATO (North Atlantic Treaty Organization) and as a network systems integrator for a commercial aerospace company. 

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