What is 3WS?

3 WS is Wayahead Windows Weighing System, Wayahead’s dispensing, mixing, manufacturing and packaging system. 3WS will guarantee that the correct Weight, of the correct Material, will be used in the correct Product, also confirming that Lot Status and Use-by-Date are OK. All these checks are completed automatically, without the need for the operator to hand-write labels or record production usage. Any site using 3WS improves throughput, during Dispensing, Mixing, Manufacturing and other production phases. Barcode labelling of Lotnos, Batches and also dispensing activity is included. Using 3WS, you cannot miss out or double-up a material during weighing, mixing or packaging. Product compliance is assured to the highest quality levels, using less operators, in a faster process.

3WS - stands for Wayahead Windows Weighing System.

It is a Wayahead product, which is extensively validated by our Software Quality Assurance Plan. It is a Windows product and runs on all Windows platforms. It is a Weighing application containing all the functionality required by manufacturing companies. And it is a complete System, incorporating many production activities with extensive reporting. 3WS is very stable and each site can customise their usage of each feature. The system is installed at many sites worldwide and has been extensively validated to FDA level at most of these sites. 3WS has many significant features, such a Quantity Sufficient processing, Potency management etc. All weighing or mixing programs have large displays of important details (Names and Weights). The colour bar to show weighing progress, from yellow, to green, then red if overweight, is a major feature with large warning messages. Periodic balance calibration and servicing, is guaranteed by 3WS. 3WS can be interfaced to any ERP system. This allows systems, such as SAP, BPCS, JD Edwards, MFG-PRO, Pronto etc, to transfer material, lotno or work order data to 3WS. After dispensing, the usage data about work orders or lotnos can be automatically transferred back to ERP.

System Validation

Validation is always important and we have taken most of the hard work out of this necessary exercise by developing a Validation module. This module contains all validation tests and in its simplest form can be used to print out the Validation Manual. It can also be used to activate a range of tests to be completed. You then print out the nominated test scripts, ready for testing to start. Each test script records the user, date, test method, expected results and pass or fail status. Validation History (script plus test results) is electronically generated and printed to speed up and improve validation testing. Please read the Validation section, for more information on validation.

How 3WS Works?

D uring each installation project, Wayahead will work the local users, to generate the relevant Installation Qualification (IQ) documentation. If the site is not familiar with IQ procedures, Wayahead can manage this important phase of the project, from File Server setup, through database creation, to workstation configuration of electronic balances, barcode scanners and barcode printers. It is recommended to prepare a Standard Operating Procedure (SOP), to document the configuration of each type of hardware connected to a workstation, such as balances, printers and scanners. User training will also be completed during the initial phase of 3WS implementation. Training is usually conducted in separate sessions for system admin users, production supervisors and finally operators. At the end of the first week onsite, the agreed system parameter settings, for the site to activate 3WS features, will be established and these settings will be included in future OQ and PQ documentation. IQ and training usually takes two weeks onsite.

Features

3WS Dispensing

The main 3WS Dispensing module will manage all aspects of a sites weighing requirements. Core functionality covers Lotno barcode scanning, then electronic balance selection and regular calibration.

Barcode Labels

3WS can print many different barcode labels, using a variety of third-party printing tools such as Bartender, ZPL (Zebra), IPL (Intermec), Crystal Reports, etc. Any third-party barcode utility can be used.

3WS exchange

All 3WS sites are linked to the ERP system onsite. Examples are SAP, JDE, BPCS, Movex etc. Wayahead have developed a comprehensive interface management program, called 3WS-Exchange to manage the transfer of data between 3WS and your current system.

Data Audit Trail

Wayahead have developed a validated data audit trail, to regulatory level, which manages all database changes, to all fields, in all tables. Each record change, is recorded to identify the date, time, user, workstation, program and the before & after data values.

Electronic Batch Record (EBR)

Throughout 3WS, many processes require the user to complete their Electronic Signature (eSignature), to record who they are and whether they are authorised to complete an activity. The eSignature process includes all 21CFR11 requirements.

Manufacturing Module

Mixing of previously weighed items, can be managed, by barcode scanning the details from the earlier Dispensing label. The Lotno useby-date and status can be re-checked during the assembly or mixing operations. The manufacturing program can manage two phases of production.

Packaging Module

3WS can also control, check, label your packaging materials. The process of assembling, then delivery to the production area, is different for packaging materials. Packaging materials are usually over-issued, to account for machine overruns, larger bulk shipment of materials, etc. The Packaging module, caters for these conditions, by barcode confirming the lotno of material.

Case Studies

Catalent

Industry : Pharmaceuticals

Problem

In the early 90s, Catalent was looking for an integrated PLC/dispensing system that was off the shelf, customisable for PLC gelatine operation and meets the TGA requirements. There are 6 dispensaries and an Allan Bradley PLC dispensing & manufacturing suite at Catalent. The PLC suite is used to control three melters to produce gelatine capsules.

Solution

Catalent selected 3WS as it offers versatility in the integration of the PLC production processes and other dispensing / quality control features. As Qi Feng, Catalent’s IT / Validation Officer explained, “3WS is a comprehensive dispensing system and meets our production needs. The use of PLC interface, dispensing functions and management are quite straightforward and well designed. 3WS provides useful interface program to exchange data with our ERP system”.

Wyeth Nutritionals China

Industry : Pharmaceuticals

Problem

Based on 3WS track record and long association with Wyeth since 1990, Wyeth’s US based Senior Management recommended WNC to install 3WS. Initially, WNC’s local management raised a concern regarding post-installation support by Wayahead. However, as Mr. Jiang Xi, WNC’s 3WS administrator explained, “For the past four years of operation, 3WS has been very stable and it has never shutdown since 2003. We use the system around the clock, 24 hours per day, 7 days a week. We are also very satisfied with Wayahead effective and timely support”

Solution

3WS is extensively used at WNL. The barcode labeling function in 3WS is used in WNC in warehousing, QA, Dispensary and Manufacturing. The design of each label has been customized by WNC, to suit their requirements. Other 3WS functions heavily used is the visualized weighing displays and control with tolerances, LotNo FIFO feature and allocations, Lot expiry date checking and the automatic interfaces between 3WS and SAP. These interfaces transfer material, lotnos and work order downloads from SAP and material usages upload back to SAP.

Lipa Pharmaceuticals

Industry : Pharmaceuticals

Problem

Since the inception of the company, market demands for pharmaceuticals and healthcare products have steadily increased, not just for domestic demands, also overseas. To acquire and retain a TGA license to manufacture therapeutic goods, a site must be able to demonstrate, during each factory audit, compliance with manufacturing principles including stringent codes of good manufacturing practice (GMP).

Solution

3WS was installed and validated at the original LIPA site, in mid 2000. This project lasted six weeks. There have been numerous updates over the last seven years. All updates are fully validated, as per TGA requirements. LIPA use automatic interfaces between 3WS & ERP, to transfer materials, lotnos and work orders to 3WS, then upload usage values back to ERP. As Pendy Chan puts it, “The speed of the interfaces, improved our dispensing capacity considerably”. All material dispensing, barcode labelling and manufacturing operations, are managed by 3WS, including a complete FDA level audit trail of all activities