Master data integration

The other master data elements for which an integration process is required are recipes. Recipes used within the PP/DS module are tightly integrated with the recipes in the ERP system. For complexity reduction in master planning, as outlined in the SNP section above, simplified recipes are used in SNP. These are derived from the PP/DS recipes by a flexible, automated conversion process. 

An integration interface transforms master data and dynamic data by mapping objects to the respective target model. 

Due to the fact that one might not want to use all ERP business data objects in the APS system, an integration model is used to define for which plants, resources, materials, customers, etc., the integration interface should be active. The APS system also allows to maintain additional master data or to modify and enhance master data that came from the ERP system. Sometimes there are also additional types of master data (e.g. resource setup matrix) or information fields to master data (e.g., scheduling horizon) that really have no analogy in the ERP system and thus have to be maintained directly in the APS system. 

Documentation comprises procedures, instructions, test methods,batch records, and so on that are documented and controlled. Documentation is prepared, reviewed, and approved by qualified personnel. Approved copies of documents are distributed to relevant departments and superseded copies are retrieved and archived. The retention period for each type of document is specified. Documents are issued with document and version numbers for ease of identification and reference. Master copies of documents are filed at secured locations with authorized access. Master copies stored in electronic media require validation in accordance with FDA regulation 21 CFR Part 11 (see Section 9.6.3) to assess the security of access and data integrity. Operators are trained and retrained to only apply the latest approved documents. 

The integrity of the data held within any system is essential to the successful operation of a regulated business process. This can only be guaranteed if effective security measures have been established to prevent any unwarranted access to the data, whether intentional or not. The generation of electronic copies of master production records without any apparent controls to ensure then-authenticity or data integrity will not be overlooked by regulatory authorities. ... 

Figure 3. Comparison of experimental data of network D 0.4 and calculated master curves, using any of the curves of Fig. 2 and Eqs. 5 and 6 with appropriate adjustable constant and integration limits.

The Chem Master Workstation is a gas chromatography and gas chromatography-mass spectrometry data-processing system that speeds the flow of data through the laboratory and provides essential quality-assurance and quality-control review. It is a PC-based integrated hardware/ software system that converts gas chromatographic and gas chromatography-mass spectrometric data into reliable analytical reports. 

All current SOPs should be available in the work area in which they are used. Each person who may need specific SOPs for his/her work should also have them, perhaps in a file near his/her desk. In addition, there should be a location in which master SOPs for all activities are filed and all SOPs should also be archived so that past revisions are accessible. All obsolete SOPs, however, should be removed and filed away from the work area and clearly identified as obsolete. The decision to revise an SOP must be based on sound observations and protocols that point to improved data accuracy and integrity. Such decisions can be based on a new procedure, a new piece of equipment, etc. SOPs are dynamic documents and should be considered for revision on a regular basis with input from the technicians and scientists doing the work. 

Select master method for data processing (integration, quantitation, spectral evaluation, etc.). 

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