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1 Bartech Data Systems Pvt. Ltd. Introduces - Complete Global Barcode Track & Trace Solutions [Version XII] Bartech s O R B I S, is an advanced Software Technology, for harmonizing all the barcoding mandates of D.G.F.T., MoHFW and in accordance to GS1 advisories and standards. As we earlier mentioned, a perfect combination, of High Quality Hardware, Consumables & Software technology, is necessary for the desired application of barcodes in Pharmaceutical Industry. This job of striking a perfect combination, with requisite validations, is done by O R B I S. Following GS1 Health Care Standards is very important and even mandatory for Pharmaceutical Exports D.G.F.T. The basic fundamental behind these standards application is to avoid forgery in Health Care Products, by maintaining Complete Centralized Data Synchronization. There are 3 packaging levels, on which DGFT has concentrated from the very initial stage of mandates: 1. Primary Level Packaging (Item level Packaging) 2. Secondary Level Packaging 3. Tertiary Level Packaging (Carton / Shipper level Packaging) According to DGFT Mandate, the last dates for these packaging levels, following the barcoding GS1 Standards, is divided in 3 parts: Tertiary Level Packaging With effect from 1 st October, 2011 Successfully Applied Secondary Level Packaging With effect from 1 st January, 2013 Successfully Applied Primary Level Packaging With effect from 1 st July, 2014 To be applied

2 Global Barcode Track & Trace Solutions 2 So, let s discuss, what are the mandatory requirements, and how Bartech s ORBIS Software solution, can help Pharmaceutical Companies, to get in line with standards. Tertiary Level Packaging: The level of final packaging done, before exporting the products, is Tertiary Level Packaging. Shippers are a common example of this level of packaging. O R B I S, will help a company, follow all the required standards of this level. All the mandatory standards are well incorporated and ready for validations, in O R B I S. The mandates mainly state, that all of the Pharma Exports, should have a complete Track & Trace in their database. All the mandates can be easily streamlined, validated, and associated with required hardware, via O R B I S. This level of packaging, will contain 2 Barcodes on the shipper of homogenous pack, and 1 Barcode if the shipper is heterogeneous in contents. contents. The homogenous pack s guidelines, as per the mandates are. The barcode label for the homogenous shipper will have complete identification details of the shipper Symbologies Allowed: GS1 128 G.T.I.N.(Global Trade Item Number) Expiry Date: (Format - YYMMDD) Lot / Batch Number A Barcode, carrying the above mentioned details, with their application identifiers, will be present on a label on Shipper pack. This barcode will be the First Barcode, which can be either of one symbologies: GS1 128 & GS1 DataMatrix. Sample GS1 128 Barcode

3 Global Barcode Track & Trace Solutions 3 Now, there will be one more barcode, carrying SSCC [Serial Shipping Container Code], on this label below, for homogenous shipper packs. On the left hand side, you can see a sample Tertiary Level Label for Homogenous Packs. You can see, it contains 2 barcodes. The second barcode will contain only the SSCC [Serial Shipping Container Code], along with Country Code (890 for India) and Company Prefix. Secondary Level Packaging: In simple words, Secondary Level of Packaging, is a collection of all the primary level of packs. It is a parent unit of primary level packs. At this level, there will be only one barcode, for carrying the following mandatory information: GS1 128 OR GS1 DataMatrix OR GS1 DataBar G.T.I.N.(Global Trade Item Number) Expiry Date: (Format - YYMMDD) Lot / Batch Number Serial Number This serial number will be captured in a barcode, for both, Secondary and Primary levels of packaging. GS1 DataBarsymbols can carry more information and identify small items than the current EAN/UPC bar code. GS1-128 GS1 DATAMATRIX GS1 DATABAR

4 Global Barcode Track & Trace Solutions 4 Primary / Item Level Packaging: Item Level Packaging, as the name suggests, is the first packaging, done by the Pharmaceutical Company and the last packaging thrown by the customer. It includes, - Blisters, Injections, Mono-Cartons, etc. GS1 DataMatrix is a 2D (two -dimensional) barcode that holds large amounts of data in a relatively small space. The mandate says that only one symbology is allowed at the Item Level Packaging, and that is: GS1 DataMatrix Two Dimensional Barcode. Information to be incorporated at this level: GS1 DataMatrix G.T.I.N.(Global Trade Item Number) Serial Number O R B I S, a Pharmaceutical company, is no longer With the help of required to validate and verify the standards, practically monitor the operations, and monitor the changes. O R B I S owners, will be provided with regular updates, and the software itself will apply standards and even validate the human actions. O R B I S, is a complete GS1 Solution, which provides a company with a hassle free environment, where: Entire barcoding responsibility, GS1 Standards Application, Validations, Database Management, etc., are managed via O R B I S.

5 Global Barcode Track & Trace Solutions 5 Bartech is in Barcoding Software development since 1996, and has various ready to deploy software solutions like: Visitor Management Solutions (V.M.S.), Asset Tracking Solutions (A.T.S.), Warehouse Management Solutions (W.M.S.), Computerized Maintenance Management Solutions (C.M.M.S.), Material & Inventory Tracking Solutions (M.I.T.S.), etc. Moreover, you will see the features details in the concluding pages of this White Paper, which will suggest that Bartech has expertise in providing more than 28 features for Advance Track & Trace Solutions. Following DGFT Mandates is just one of the 28 features. Now, let us have a look at ORBIS GOLD PRO & how it operates. Remember, all these features shown via imagery below, are mentioned in our features list in below pages, from a which a company can select the features / software versions, to get secure & futuristic software characteristics. ORBIS GOLD PRO This Version starts working right from the receipt of Raw Materials till the FG warehousing & Dispatch Receipt of Raw Material Barcoding of Raw Material Move barcoded material in Pre-barcoded Warehouse Managing Production Order via ORBIS and our Hand Held Terminal Software Solutions, for quick, safe & traceable transactions. Receipt can be verified against Production Order via Mobile Computer Software Application. After the receipt & verification of material against Production Order, it will be brought under production stages, after requisite scanning. It means, before using the material in any production stage, it will be scanned and our ORBIS will maintain record of the personnel (who scanned), time, date, production stage, production order number, etc. for future reports and reference purpose.

6 Global Barcode Track & Trace Solutions 6 Now, we will assume that the Finished Goods of the Pharmaceutical company are ready for Printing & Packaging. Hence, the FG will be sent to the Printing & Packaging Plant, where they are required to get packed in accordance to the DGFT Mandates for Indian Exports. ORBIS Gold Pro takes care of Primary, Secondary & Tertiary in its entirety. Let s have a look at one of the Plant Location and its One of the Plant Line, for description via Imagery. Online Inkjet Printing for Primary Level Packs. Now, as the Finished Materials are ready after requisite printing and packaging, they will be sent to the FG Pre-Barcoded Warehouse. I mentioned Pre-Barcoded, as under Warehouse Management Solutions (included in Gold & Gold Pro), Bartech will be barcoding the locations, for secure, quick and simple transactions. Pick List generation at the time of Delivery Order Execution. Dedicate personnel to pick the material against the pick list. This will reduce time, errors and efforts involved in picking. Scan the Barcoded location and place the material, for future location mapping. Vision System (Integrated with ORBIS) to count & verify the Primary Packs to be sent to Secondary packaging. Scan the location and pick the material, which will update Warehouse and location quantity and maintain records of Time of Scan, Pick List, Personnel, etc., for future reports and references.

7 Global Barcode Track & Trace Solutions 7 O R B I S Standard Features Following D.G.F.T. Mandates Following USFDA 21 CFR Guidelines (for Traceability Maintenance) Basic Labels Design (As per Mandates) Typical Label (Secondary & Tertiary) Redesigning & Repacking Capability Advanced supply chain visibility through item level Unique serialization Scan & Save Details (Scan the barcodes and get details saved in Database) Enhanced Database Structure All 3 Levels Incorporated (Including data recovery & backup facilities) Label Prints Database Maintenance- Till Six months from Product Expiry (Primary and/or Secondary and/or Tertiary) Supplementary Features Label Re-Print Module with Authoritative Controlling & Audit Trail Complete Label Designing & Redesigning Support (for Incorporating additional information with Version Number Tracking) Box & Shipper Packing Scanner Validations [Non-Wireless / Wireless] Pallet Packing Module [Wireless] Truck Loading & Dispatch Tracking [Wireless] Physical Stock Take [Non-Wireless / Wireless for Portability] Seamless ERP Integration By ERP Integration we mean, fetching relevant data from a company s ERP for ORBIS Masters. Any further integration will demand additional cost depending upon the level of integration. Audit Safety [Controls, Checks & Validations] MIS Reports Generation Power Server - Client Architecture Software E-Pedigree (Parent Child Relationship Management All levels incorporated) GDSN Ready Enhanced Database Structure One year Immunity against GS1 & D.G.F.T. Updates in Standards / Mandates Vision & Verification System (Hardware & Software support) Warehouse Management Modules FIFO based & Location based Identification & Dispatch Material & Inventory Tracking Modules: [RM Inwards, GRN Data Import, Put Away to Quarantine, Quality Check, Put away to Approved Location, Work Order processing, Label printing for issue process, User Privileges, Reports, etc.] RFID Support Bartech Data Systems Pvt. Ltd. G-30, Apollo Industrial Premises, Opp. MIDC (Udyog Sarathi) Office, Andheri (East), Mumbai Tel:- (022) / 168 Telefax:- (022) We are Channel Partners of:

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