OSTENDO-3WS Interfaces

Introduction AUTOMATIC INTERFACES between OSTENDO & 3WS Interfaces are available between Ostendo (ERP system) and 3WS (Weighing system), to handle all aspects of data transfer. All interfaces run continuously. AUTOMATIC INTERFACES between OSTENDO & 3WS All interfaces between OSTENDO and 3WS are AUTOMATIC. DOWNLOADS Materials, LotNos and Work Orders from OSTENDO to 3WS. UPLOADS Any weighing activity within 3WS, including Lotno usage details, will be instantly uploaded back from 3WS to OSTENDO.

Interface options The following interface options are available: INTERFACE SETUP to establish the rules of interface management INTERFACE VALIDATION is available with test scripts available MATERIAL Download from Ostendo to 3WS LOT NO Download from Ostendo to 3WS WORK ORDER Download from Ostendo to 3WS USAGE Upload from 3WS to Ostendo DATA AUDIT Trail management of all data change during interface activity, with enquiry log A data audit trail to FDA level requirements (21 CFR Part 11) is generated in 3WS for all data access. Validation test scripts and test results are available, which can be modified to suit each site. Reporting and enquiry functionality is available across all interface activity.

3WS Interface Parameters setup Different Rules for: automatic processing re-sending data pre-allocated Lots integrity checks upload conditions Interface Parameters screen Setup of parameter options for each separate Interface’s rules.

MATERIAL records on Ostendo are included in an XML file, which is downloaded to 3WS Example XML data file

3WS MATERIAL DOWNLOAD processing … Screen display during download Audit Report for interface activity

3WS Screens – MATERIAL details Ostendo Material data has been transferred to 3WS 3WS MATERIAL details screen after interface downloaded Ostendo data

Each Lot record is included in an XML file, using Ostendo-to-3WS LOT interface Example XML data file

3WS LOT NO DOWNLOAD processing …. Data Rejected! Screen display during download Audit Report of interface activity

3WS Screens – LOT NO details 3WS LOT NO details screen after interface downloaded Ostendo LotNo data

Work Order - downloaded XML data file

3WS WORK ORDER Download details 3WS Screen display of Order HEADER after download from Ostendo

3WS Screens – WORK ORDER Item detail Not started yet! To Date = zero 3WS Screen display of Work Order ITEM after download from Ostendo

3WS Screens – Complete ONE weighing Gross = 12.160g Tare = 10.000g Nett = 2.160g 3WS main DISPENSING screen where items are accurately weighed within tolerance.

3WS Screens – View the DISPENSING label ALL weighing information can be included on the Dispensing label … and the label is printed 3WS DISPENSING label can be viewed online before printing, if necessary.

Upload Consumption XML datafile to Ostendo

DATA AUDIT Trail – 21 CFR Part 11 compliant Included within the 3WS Interface module, is the validated DATA AUDIT Trail functionality. The DATA AUDIT Trail module manages all data changes, recording the User, Date, Time, Program, Activity, plus other database and network information. The audit trail retains the complete “Before & After” data content of all records changed for online review OR external offsite copy. This is an FDA requirement. A separate brochure is available for the (FDA level) DATA AUDIT Trail module.

3WS DATA AUDIT Trail screen enquiry Data Before Data After View Online: The two (2) changed fields are displayed in YELLOW BLAH BLAH blah Table, activity, date, time, user, are recorded Data Audit Trail process – Audit Viewer screen. Changed data is in YELLOW.

OSTENDO-3WS Interfaces conclusion VALIDATION - Comprehensive validation test scripts are available for the interfaces between Ostendo & 3WS. This validation protocol includes validation test scripts and completed validation test results. AUDIT TRAIL - All activities are included in the 3WS Data Audit Trail module, which manages data changes to the FDA (21 CFR Part 11) requirements. INTERFACES - All activities are included in the Interface transactions between 3WS and your Ostendo system. This includes Material, LotNo , Work Order downloads from Ostendo and Usage uploads back to Ostendo. ENQUIRY & REPORTING - A full set of enquiry and reporting options are available to print all interface activity. A fully validated & automatic link between Ostendo & 3WS Many thanks.