OSTENDO3 WS Interfaces Introduction Interfaces are available between

OSTENDO-3 WS Interfaces

Introduction Interfaces are available between Ostendo (ERP system) and 3 WS (Weighing system), to handle all aspects of data transfer. All interfaces run continuously. AUTOMATIC INTERFACES between OSTENDO & 3 WS All interfaces between OSTENDO and 3 WS are AUTOMATIC. DOWNLOADS Materials, Lot. Nos and Work Orders from OSTENDO to 3 WS. UPLOADS Any weighing activity within 3 WS, including Lotno usage details, will be instantly uploaded back from 3 WS 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 3 WS LOT NO Download from Ostendo to 3 WS WORK ORDER Download from Ostendo to 3 WS USAGE Upload from 3 WS 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 3 WS 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.

3 WS 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 3 WS Example XML data file

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

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

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

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

3 WS Screens – LOT NO details 3 WS LOT NO details screen after interface downloaded Ostendo Lot. No data

Work Order - downloaded XML data file

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

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

3 WS Screens – Complete ONE weighing Gross = 12. 160 g Tare = 10. 000 g Nett = 2. 160 g 3 WS main DISPENSING screen where items are accurately weighed within tolerance.

3 WS Screens – View the DISPENSING label ALL weighing information can be included on the Dispensing label … and the label is printed 3 WS 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 3 WS 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.

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

OSTENDO-3 WS Interfaces conclusion VALIDATION - Comprehensive validation test scripts are available for the interfaces between Ostendo & 3 WS. This validation protocol includes validation test scripts and completed validation test results. AUDIT TRAIL - All activities are included in the 3 WS 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 3 WS and your Ostendo system. This includes Material, Lot. No , 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 & 3 WS Many thanks.