Bartech Data Systems Pvt. Ltd.

(1)

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 1st_{October, 2011}

Successfully Applied

Secondary Level Packaging

With effect from 1st_{January, 2013}

Successfully Applied

Primary Level Packaging

With effect from 1st_{July, 2014}

To be applied

Bartech Data Systems Pvt. Ltd.

Introduces

-Complete Global Barcode Track & Trace Solutions

[Version – XII]

www.bartechdata.net

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

Successfully Applied

Secondary Level Packaging

Successfully Applied

Primary Level Packaging

To be applied

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

Successfully Applied

Secondary Level Packaging

Successfully Applied

Primary Level Packaging

To be applied

Introduces

-Complete Global Barcode Track & Trace Solutions

[Version – XII]

(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. 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 contents.

 _{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.

Symbologies Allowed: GS1 – 128

Global Barcode Track & Trace Solutions

2

Sample GS1 – 128 Barcode

Tertiary Level Packaging:

O R B I S

.

Global Barcode Track & Trace Solutions

2

Sample GS1 – 128 Barcode

Tertiary Level Packaging:

O R B I S

.

Global Barcode Track & Trace Solutions

2

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

_{G.T.I.N.(Global Trade Item Number)}



_{Expiry Date: (Format - YYMMDD)}



_{Lot / Batch Number}



_{Serial Number}



Now, there will be one more barcode, carrying SSCC [Serial Shipping Container

Code], on this label below, for homogenous shipper packs.

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:

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.

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.

GS1 – 128 OR GS1 DataMatrix OR

GS1 DataBar

Global Barcode Track & Trace Solutions

3

GS1 - 128 GS1 DATAMATRIX

GS1 DATABAR



_{G.T.I.N.(Global Trade Item Number)}



_{Expiry Date: (Format - YYMMDD)}



_{Lot / Batch Number}



_{Serial Number}



Now, there will be one more barcode, carrying SSCC [Serial Shipping Container

Code], on this label below, for homogenous shipper packs.

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:

This serial number will be captured in a

barcode, for both, Secondary and Primary

levels of packaging.

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.

GS1 DataBar

Global Barcode Track & Trace Solutions

3

GS1 DATABAR



_{G.T.I.N.(Global Trade Item Number)}



_{Expiry Date: (Format - YYMMDD)}



_{Lot / Batch Number}



_{Serial Number}



Now, there will be one more barcode, carrying SSCC [Serial Shipping Container

Code], on this label below, for homogenous shipper packs.

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:

This serial number will be captured in a

barcode, for both, Secondary and Primary

levels of packaging.

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.

GS1 DataBar

Global Barcode Track & Trace Solutions

3

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

_{G.T.I.N.(Global Trade Item Number)}



_{Serial Number}

GS1 DataMatrix

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:

With the help of

O R B I S

, a Pharmaceutical company, is no longer

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

.

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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.

Global Barcode Track & Trace Solutions

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transactions.

Global Barcode Track & Trace Solutions

5

transactions.

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Global Barcode Track & Trace Solutions

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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.

Vision System (Integrated with ORBIS) to count & verify the

Primary Packs to be sent to Secondary packaging. 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.

Scan the Barcoded location and place the material, for future location mapping.

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 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.

Global Barcode Track & Trace Solutions

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Global Barcode Track & Trace Solutions

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O R B I S

– Standard Features

Supplementary Features

Following D.G.F.T. Mandates Label Re-Print Module with Authoritative Controlling & Audit_Trail Following USFDA – 21 CFR Guidelines (for Traceability

Maintenance)

Complete Label Designing & Redesigning Support (for Incorporating additional information with Version Number Tracking)

Basic Labels Design (As per Mandates) Box & Shipper Packing Scanner Validations [Non-Wireless /_Wireless] Typical Label (Secondary & Tertiary) Redesigning & Repacking

Capability Pallet Packing Module [Wireless] Advanced supply chain visibility through item level Unique

serialization Truck Loading & Dispatch Tracking [Wireless] Scan & Save Details (Scan the barcodes and get details saved

in Database) Physical Stock Take [Non-Wireless / Wireless for Portability] Enhanced Database Structure – All 3 Levels Incorporated

(Including data recovery & backup facilities)

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.

Label Prints Database Maintenance- Till Six months from

Product Expiry (Primary and/or Secondary and/or Tertiary) Audit Safety [Controls, Checks & Validations]

MIS Reports’ Generation Power Vision & Verification System (Hardware & Software support) Server - Client Architecture Software Warehouse Management Modules

E-Pedigree (Parent Child Relationship Management – All

levels incorporated) FIFO based & Location based Identification & Dispatch GDSN Ready Enhanced Database Structure

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.]

One year Immunity against GS1 & D.G.F.T. Updates in

Standards / Mandates RFID Support

Global Barcode Track & Trace Solutions

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We are Channel Partners of:

Bartech Data Systems Pvt. Ltd. G-30, Apollo Industrial Premises,

Opp. MIDC (Udyog Sarathi) Office, Andheri (East), Mumbai – 400 093

Tel:- (022) 26878148 / 168 | Telefax:- (022) 26878167 Email: sales@bartechdata.net, bartech@rediffmail.com