HLS Process Improvement

7/30/2019 HLS Process Improvement

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JDE For Life Sciences

Madhav Garikapati


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2009 Wi ro Ltd - Confidential3

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Life Sciences

Life Sciences consists of

Pharmaceutical

Medical Equipment manufacturers


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Pharmaceutical Overview Characteristics of Pharmaceutical Company

API Active potent Ingredients

Expiration dating heavily regulated

Lengthy quality test duration

Long product development cycles (+7years)

FDA approval mandates productionprocess

Out of spec results require writtendeviations

EBR, Electronic batch Records

Typically discrete manufacturing

End to end Factory Audits are mandatory

Cont ..


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Characteristics of a Medical Devices Company

Characteristics of a Medical Devices Company

Complex manufacturing process

High growth industry but many small players

Contract manufacturing is typical

Outside sterilization tracking can be complex

Kitting & Return to refurbish is typical

CAPA, Corrective & preventative action

DHR, Device History Records Typically Lean manufacturing focused

Contract management highly regulated


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2010 Wipro Ltd - Confidential6

Wipro JDE PHARMA Solution

Proposition


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Cont ..

Typical Pharma Requirements

Advanced Lot Control consisting of new lot dates, lot effective dates, percentage of

remaining life, manufactured item expired date calculation & mass lot expiration update

Conditional Lot Processing meaning the lot is not available for selling to outside customers

but available for transactions like sales transfers.

Lot trace & track

For medicines return it can be effectively managed through return material authorization

Batch wise costing & price managementAbility to store & retrieve multiple prices like customer price, MRP, Wholesale price etc

Ability to calculate different taxes on different type of medicines. Some medicines have

VAT, some have no tax etc.

As the supply chain process is all dependent on credit cycles, it is important to track &

control business transactions on credit limit & credit aging

Quality being a mandatory requirement, drugs having batch short expiry dates have to beprevented from transactions


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Cont ..

Another Pharma requirement is expired batches need to be taken back from customers. DifferentScenarios here can be

Products taken back here & customers given credit Note

Good Products taken back which can be sold to other customers (Sales Return)

Products taken back & replacement products given etc.

Some other Pharma requirements can be

It is important in to track the product packaging details like number of boxes, cases etc &

print it on the invoice.

To mention the drug manufacturer details of the batch on the invoice

Client Specific Process Improvements

1.JDE E1 compliance today happens through a batch job after entry. Because of this some orders

can be struck which is a good thing. As a process improvement the compliance can be takenforward to happen at order entry stage itself by building a matrix for item vs. customer(Product Vs

Hospital or Pharmacy)

11.Pricing which happens through BAM can be totally configured to be done in E1.

Third one is 21CFR11

21CFR11 validation This is a very important requirement with Pharma. This consists of

Audit Table Trigger

Typical Pharma Requirements(Cont..)


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Audit Table triggers: As per FDA regulations any columns in any tables can be set up for table audittriggers. Once activated, if any value is changed then the old value as well as the new value is

stored in the shadow table along with the user name and machine IP. JD Edwards EnterpriseOne provides the capability to select specific columns in a table for auditing. You can configure

JD Edwards Enterprise One to generate an audit table when table records are inserted, updated,

or deleted. The audit records contain data such as:

Before and after values

Time and date of the transaction

The user who made the modification

Electronic Signature: In addition, we can configure JD Edwards Enterprise One interactive andbatch applications to require an electronic signature approval when a user tries to change the

data on an application or submit a report. A record of the approval is recorded in the Signature

table (F9500005). The table records this information:

Approver of the change

Reason for the approvalApprover's user ID

Users role

Date and time of the approval



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We can view the information in the audit and electronic signature tables using the View

Audit/Signature Information application (P9500005) or by generating reports (R9500004,

R9500005, R9600006). The reports display all the audit and signature information in an

easy-to-read Adobe Acrobat PDF file that can be printed to hard copy or saved in digital

format.



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Example for Electronic Signature


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Electronic Sign (Cont..)

You have two choices to initiate electronic signature. Either update lot status code or updatelot expiration from Lot dates


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By making changes to Lot expiration dates electronic signature is initiated


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This is the electronic signature that requests user id (JDE), reason code(3) and password(JDE) to accept the Update. Comment field is for additional information


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View Audit & Signature Information in JDE

In work with audit & signature information select signature & audit


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This is the electronic registration of changes that affected the table that you have enabled auditing. Youcan also display the columns that were changed by showing before & after images. Select the row toview the before & after image


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Thank You

Documents

HLS Process Improvement