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
Typical Pharma Requirements(Cont..)
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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.
Typical Pharma Requirements(Cont..)
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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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Electronic Sign (Cont..)
By making changes to Lot expiration dates electronic signature is initiated
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Electronic Sign (Cont..)
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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View Audit & Signature Information in JDE
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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View Audit & Signature Information in JDE
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Thank You