GTI - News


 

GTI - Newsletter from 20.07.2004


GTI to Develop Document Management System for Regulated Industries
Scarabaeus-Release 05.00.0007
Affordable Workshop for Production Planning Using MS Project

 

GTI to Develop Document Management System for Regulated Industries

 

Currently under development at GTI, the document management system PharAO® has been custom designed for the specific requirements of the pharmaceutical and other regulated industries. The roll-out for the first version of the software is scheduled for September of 2004. PharAO® is the result of a close cooperation with Saperion AG, one of the leading manufacturers of DMS solutions.

PharAO® comes with a range of add-on options, and includes all standard DMS functionalities, such as the copying of scanned documents, extensive indexing options, and easy document research, copying documents directly from MS Office, automatic version management of document changes, read-only, long term archiving, configurable workflows, a differentiated rights system, etc.

PharAO® will already contain complete document templates for the validation of computer aided systems (e.g., SOPs, validation master plan, risk analysis, DQ, IQ, OQ, PQ, validation report), plus industry-specific pre-configured workflows. Moreover, the system is intended to include a dossier management according to the eCTD standard. As a pharmaceutically qualified system, PharAO® is naturally GMP compliant according to all relevant EU and FDA guidelines, and thus fully validation-enabled.

Users of the PPS / MES solution Scarabaeus+ will be able to use PharAO® as integrated add-on option. Each report generated in Scarabaeus+ can automatically be archived in read-only form. The indexing is fully automated so that invoices are assigned to the proper customers, purchase orders to the proper vendors, and analytical protocols to the proper batches. Document research is equally smooth: With a single mouse click you retrieve, for instance, all documents archived for a batch you selected in Scarabaeus+.

 

Scarabaeus Release 05.00.0007:
LIMS Functionalities Now to Include Single Sample Management

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Scarabaeus+ integrates all relevant QC functionalities, thus eliminating the need for running a parallel LIMS (Lab Information Management System). This is even more true because, with Release 05.00.0007, Scarabaeus+ will include single sample management, meaning that Scarabaeus+ will manage each sample with reference to the unique ID of the goods receipt batch and the triggered test order. Identification can be effected any time, using a unique bar code label. The same goes for reserve samples, which are managed in a special system storage whose stock is exempt from standard access and excluded from all MRP considerations (so-called shadow stocks). Reserve stocks can be transferred back into the active goods stocks through an authorized stock transfer.
Please request more information on Scarabaeus+.

 

Affordable Workshop for Production Planning Using MS Project

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There are still a few openings in our workshop “Production Planning Using MS Project” in conjunction with the 2nd Scarabaeus Conference that is scheduled for September 24 in Kleinmachnow near Berlin! The registration fee is € 165,- per attendee.

Workshop Profile: A high number of production orders to be processed usually results in a number of conflicts in regard to resource availability and delivery dates, as well as bottlenecks in terms of required components. These are problems that need to be solved, while manufacturing tasks must be sequenced according to confirmed delivery dates. This includes, for instance, the logical production sequence from semi-finished to finished products. On the one hand, Microsoft Project visualizes any obstacle to a smooth production that may result from the present data status. On the other hand, it provides the option to optimize the utilization of the required resources (facilities, equipment, staff). The next step allows you to recalculate the earliest possible production date. What-if scenarios or cost calculations are examples for multiple other options provided by MS Project that could supplement your production planning in a useful way. Click here to request your registration forms.