dea compliance - production and inventory reconciliation

DEA Compliance –Production and Inventory ReconciliationProduction and Inventory Reconciliation

• SAP ECC 6.0/ERP 6.0

SAP Solution BriefSAP Solution Brief

IndexSynopsis11

Industry Requirements22 Industry Requirements22

IT Sapiens’ Solution Features33

IT Sapiens’ Solution Set44

IT Sapiens’ Solution Features Demo55

Solution Merits66

Our Value Proposition77

1Questions ?88

p

June 6th 2015 ©2015 IT Sapiens, Inc. Proprietary and Confidential

Synopsis11

Pharmaceuticals and Chemical Industry: Products could consist of Active Ingredients which are “Controlled Substances”

under DEA Schedules For drug abuse prevention and control, per Title 21 USC-CSA (Unites States Code-

Controlled Substance Act) and 21 CFR Part 1300, laws exist for: Registration of Individuals/Companies handling or using Controlled Substance Quota application, procurement, handling, disposal etc of Controlled substance Records keeping and Reports requirement Penalties for Offenses

Current practices by DEA Registrants to track and report Controlled Substance procurement, storage, inventory, consumption, waste, thefts, etc. involves use of manual log books or computer system controls that help track and report

SAP as an ERP system provides limited out-of-the-box functionality for DEA Compliance

Many a time, compliance to DEA requirements and defending a DEA Audit could be

2

pain staking if the computer system controls in place do not provide for a seamless and automated tracking and reporting framework


Industry Requirements for DEA Compliance in SAP22

Common Industry Requirements for DEA Compliance in SAP: Master Data / Classification:

Need ability to classify Material per DEA Controlled Substance Schedule for: Raw Materials, Intermediates, Brite Stock, Finished & Packaged Products

Need ability to maintain Material State to which the Material belongs (e.g. Granulated, Blended, Compressed, Film Coated, Imprinted, Blistered, Cartoned)

Need ability to maintain the Active Ingredient that Material consists of (e.g. Pseudoephedrine)

Registration:S C Need ability to assign DEA Registration to Plants, Storage Locations, Customers,

Vendors, Warehouses, Warehouse Storage Types, etc. Need ability to activate DEA Compliance functionality by DEA Registration/Plant

P t Procurement: Need ability to maintain approved quota per DEA Registrant along with Form 222

details Need ability to check quota availability during Purchase Order Release

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Need ability to check quota availability during Purchase Order Release Need ability to automatically populate an electronic “DEA Purchasing Logbook”

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Proprietary and Confidential


Common Industry Requirements for DEA Compliance in SAP : Inventory:

Need ability to automatically track all goods movements and populate an electronic “DEA Inventory Log Book” with details of each goods movement: Date and Time of Transaction posting Transaction posting User Name and 2nd Verifier User Name DEA Schedule to which the material belongs Quantity in Active Ingredient proportion factoring Batch Potency/Assay Conversion Ratio from Material Qty to Active Ingredient proportion

f Registration change if any Production:

Need ability to automatically track all production quantities and populate an l t i “DEA P d ti L B k” ithelectronic “DEA Production Log Book” with: Total Yield quantity of Order Total Scrap quantity during Production Total Samples and Retain Samples quantity withdrawn during Production

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Total Samples and Retain Samples quantity withdrawn during Production Total Miscellaneous quantity lost during Production

(..Contd…)June 6th 2015 ©2015 IT Sapiens, Inc.



Common Industry Requirements for DEA Compliance in SAP : Inventory:

Need ability to automatically track all goods movements and populate an electronic “DEA Inventory Log Book” with details of each goods movement: Date and Time of Transaction posting Transaction posting User Name and 2nd Verifier User Name DEA Schedule to which the material belongs Quantity in Active Ingredient proportion factoring Batch Potency/Assay Conversion Ratio from Material Qty to Active Ingredient proportion

f Registration change if any

5(..Contd…)



Common Industry Requirements for DEA Compliance in SAP : Production:

Need ability to automatically track all production quantities and populate an electronic “DEA Production Log Book” with: Total Yield quantity of Order Total Scrap quantity during Production Total Samples and Retain Samples quantities withdrawn during Production Total Miscellaneous quantity lost during Production Total Yield, Scrap, Samples, Retain Samples and Miscellaneous quantities

f /in Active Ingredient Proportion factoring Batch Potency/Assay Order Operation/Phase Confirmation details Samples and Retain Samples withdrawn during Production should

t ti ll b d t d f th Q I ti L t t d t thautomatically be decremented from the Q-Inspection Lot created at the end of confirmation based Goods receipt

6(..Contd…)



Common Industry Requirements for DEA Compliance in SAP : Reporting:

Need ability to execute a “Production Yield Reconciliation in Active Ingredient Proportion” report for a date range with output showing the following: Active Ingredient Component DEA Schedules of Active Ingredient and Header Material being produced Order Number Potency/Assay of Header Material Batch Yield quantity, Scrap quantity, Samples quantity, Retain Samples quantity,

fMiscellaneous quantity of header material in: Active Ingredient proportion Header material (i.e material being produced) UoM

Q lit I ti l t li d f P d ti i t Quality Inspection lots realized from Production receipts Ability to drill down to material documents and order confirmations

7(..Contd…)



Common Industry Requirements for DEA Compliance in SAP : Reporting:

Need ability to execute a “Inventory Reconciliation in Active Ingredient Proportion” report for a date range with output showing the following: Active Ingredient Component DEA Schedules of Active Ingredient and all materials that contain the

Active Ingredient Potency/Assay of Header Material Batch Goods movement posting quantities for all inventory postings:

Q C Quantity Aggregate and details per DEA Movement Codes In Active Ingredient proportion In Header material (i.e material being produced) UoM

Q tit A t d d t il DEA M t C d Quantity Aggregate and details per DEA Movement Codes Ability to drill down to material documents and source documents This report should serve as direct input to completing and submitting DEA

Compliance related reports

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IT Sapiens’ DEA Compliance in SAP– Solution Features33

Following are IT Sapiens’ solution features for DEA Compliance in SAP: Master Data / Classification:

Provides ability at Enterprise Level to classify Material per DEA Controlled Substance Schedule:

Provides ability to maintain Material State to which the Material belongs (e.g. Granulated, Blended, Compressed, Film Coated, Imprinted, Blistered, Cartoned)

Provides ability to maintain the Active Ingredient that Material consists of (e.g. Pseudoephedrine)

Registration: S Provides ability to assign DEA Registration to Plants, Storage Locations,

Customers, Vendors, Warehouses, Warehouse Storage Types, etc. Provides ability to activate DEA Compliance functionality by Plant, Storage

L ti d W hLocation and Warehouse Procurement:

Provides ability to maintain approved quota per DEA Registrant Provides ability to check quota availability during Purchase Order Release

9(..Contd..)


Provides ability to check quota availability during Purchase Order Release Provides an electronic “DEA Purchasing Logbook”


Following are IT Sapiens’ solution features for DEA Compliance in SAP: Inventory:

Provides an electronic “DEA Inventory Log Book” that tracks and provides details of each goods movement: Date and Time of Transaction posting Transaction posting User Name and 2nd Verifier User Name DEA Schedule to which the material belongs Quantity in Active Ingredient proportion factoring Batch Potency/Assay Conversion Ratio from Material Qty to Active Ingredient proportion f Registration change if any

10(..Contd…)



Following are IT Sapiens’ solution features for DEA Compliance in SAP: Production:

Provides an electronic “DEA Production Log Book” that tracks all production quantities and inspection lots reported with: Total Yield quantity of Order Total Scrap quantity during Production Total Samples and Retain Samples quantities withdrawn during Production Total Miscellaneous quantity lost during Production Total Yield, Scrap, Samples, Retain Samples and Miscellaneous quantities

f /in Active Ingredient Proportion factoring Batch Potency/Assay Order Operation/Phase Confirmation details Samples and Retain Samples withdrawn during Production are

t ti ll b d t d f th Q I ti L t t d t thautomatically be decremented from the Q-Inspection Lot created at the end of confirmation based Goods receipt

11(..Contd…)



Following are IT Sapiens’ solution features for DEA Compliance in SAP: Reporting:

Provides a “Production Yield Reconciliation in Active Ingredient Proportion” report for a date range with output showing the following: Active Ingredient Component DEA Schedules of Active Ingredient and Header Material being produced Order Number Potency/Assay of Header Material Batch Yield quantity, Scrap quantity, Samples quantity, Retain Samples quantity,

fMiscellaneous quantity of header material in: Active Ingredient proportion Header material (i.e material being produced) UoM

Q lit I ti l t li d f P d ti i t Quality Inspection lots realized from Production receipts Ability to drill down to material documents and order confirmations

Has served well in easily defending a DEA Audit

12(..Contd…)



Following are IT Sapiens’ solution features for DEA Compliance in SAP: Reporting:

Provides a “Inventory Reconciliation in Active Ingredient Proportion” report for a date range with output showing the following: Active Ingredient Component DEA Schedules of Active Ingredient and all materials that contain the

Active Ingredient Potency/Assay of Header Material Batch Goods movement posting quantities for all inventory postings:

Q C Quantity Aggregate and details per DEA Movement Codes In Active Ingredient proportion In Header material (i.e material being produced) UoM Q tit A t d d t il DEA M t C d Quantity Aggregate and details per DEA Movement Codes

Ability to drill down to material documents and source documents This report should serve as direct input to completing and submitting DEA


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Compliance related reports Has served well in easily defending a DEA Audit




Following IT Sapiens’ SAP Solution Set delivers Industry desired functionality: Master Data:

Custom screen in Material Master to maintain DEA relevant data DEA Functionality Activation at Plant level Assignment of DEA Registration # to Plant, Storage Location, Warehouse DEA Movement Codes per 21 CFR Part 1300

Change Control: Custom Authorization Objects for maintaining every field on Batch Master and

every characteristic in Batch Master C A h i i Obj f Ch i i V l i Custom Authorization Objects for Characteristic Value maintenance

Purchasing Process Execution: Maintain Approved Quota per DEA Registration with Form 222 Details A d Q t h k d i P h O d R l Approved Quota check during Purchase Order Release DEA Purchasing Log book population at every PO creation and change

Inventory Movements from Txns MIGO, MB** : Movements verified by 2nd User Verification process

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Movements verified by 2nd User Verification process DEA Inventory Log book population at every Goods Movement (Contd…)


Following IT Sapiens’ SAP Solution Set delivers Industry desired functionality: Production/Process Execution:

SAP standard Txn for Order Confirmation with Auto Goods receipt Popup Screen to minutely report:

Actual Yield at end of Production run Actual Scrap at end of Production run Actual Samples drawn in the Production run Actual Retain Samples drawn in the Production run Actual Miscellaneous quantity that cannot be collected and stored R l i DEA P d i L b k d DEA I L b k l i Real-time DEA Production Log book and DEA Inventory Log book population

at every Order Confirmation or reversal with posting quantities in Base UoMand in Active Ingredient Proportion, factoring Batch Potency/Assay

Q lit M t Quality Management: Auto posting of Quality Inspection Lot Stock specific Samples and Retain

Samples withdrawal Ability to reverse Samples Posting and Retain Samples Posting



Ability to reverse Samples Posting and Retain Samples Posting(..Contd..)


Following IT Sapiens’ SAP Solution Set delivers Industry desired functionality: Reporting:

Quick response reporting based on real-time collection of required information during transactions execution

Production Log Book based “Production Yield Reconciliation in Active Ingredient Proportion” report

Inventory Log Book based “Inventory Yield Reconciliation in Active Ingredient Proportion” report



(…Contd)

IT Sapiens’ Solution Features Demo – Master Data55

Ability to Maintain DEA Relevant Data in Material Master:

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(Contd..)


IT Sapiens’ Solution Features Demo –Functionality Activation and Set Up55

Custom Transactions for Functionality Activation and Set up:

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(..Contd..)June 6th 2015 ©2015 IT Sapiens, Inc.


IT Sapiens’ Solution Features Demo – Approved Quota check in Purchasing55

Approved Quota check during Purchase Order Release:

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IT Sapiens’ Solution Features Demo – DEA Purchasing Log Book55

DEA Purchasing Log Book showing details of Quantity Ordered:

20



IT Sapiens’ Solution Features Demo – 2nd Verification during Inventory Goods Movement55

2nd Verification Prompt during Inventory Goods Movement:

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IT Sapiens’ Solution Features Demo – DEA Inventory Log Book55

DEA Inventory Log Book showing goods movement quantity in Active Ingredient Proportion and other details:

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IT Sapiens’ Solution Features Demo – Production/Process Execution Yield Reporting55

Production/Process Yield Reporting during Order-Phase Confirmation:

23 (..Contd..)June 6th 2015 ©2015 IT Sapiens, Inc.



Auto Goods Movement Posting from Order Confirmation:

Samples

R iRetainSamples

GoodsGoodsReceipt

Scrap Goods ReceiptScrap Goods ReceiptTo Blocked Stock




Auto Posting of Samples and Retain Samples Withdrawal from Quality Inspection Lot at end of Order Confirmation:

GoodsReceipt

Open Q-Stock to Post

Samples

Retain



Samples


DEA Production Log Book showing goods movement quantity in Active Ingredient Proportion and other details:

26 (..Contd..)June 6th 2015 ©2015 IT Sapiens, Inc. Proprietary and Confidential

IT Sapiens’ Solution Features Demo – Production Yield Reconciliation Report55

Production Yield Reconciliation Report showing quantities in Active Ingredient Proportion and other details:


IT Sapiens’ Solution Features Demo – Inventory Reconciliation Report55

Inventory Reconciliation Report showing quantities in Active Ingredient Proportion with Totals per DEA Movement Code and other details:


IT Sapiens’ Solution Features Demo – Inventory Reconciliation Report55

Inventory Reconciliation Report showing quantities in Material Base UoM withTotals per DEA Movement Code and other details:


Solution Merits66

IT Sapiens’ “DEA Compliance – Production and Inventory Reconciliation Solution” Merits: Real time Log Books to seamlessly track and log all Purchasing, Production, Inventory

Transaction postings with quantities in subject Material Base UoM and in Active Ingredient Proportion

DEA Compliant process orchestration from Purchasing Inventory Consumption Manufacturing Quality Management (QA/QC labs too) Physical Inventory etc

All Inventory Postings are logged without exception Performance optimum and content rich reports for Production Yield Reconciliation and

Inventory Reconciliation Customers have observed that these reports serve as direct input for completing and

submitting DEA Compliance related reports to DEA, without requiring offline workingC Customers have observed that this solution has helped respond to DEA Audits successfully

Functionality involves NO SAP SOURCE CODE MODIFICATION



Our Value Proposition77

Reduced TCO, Highest First Pass Yield and Highest Quality from: Strong expertise in providing end-to-end Supply Chain Solutions Strong Expertise implementing SAP, enriching Business processes and

alleviating GAPs in SAP, for Biologics / Life Sciences, Consumer Products, Pharmaceutical, Chemical and High-Tech Industry segments

Very experienced consulting resource base with 13+ years experience and y p g y pdeep cross-functional expertise

Rich Knowledge base of custom solutions to address GAPs in most SAP applicationspp

Ability to demonstrate end-state on Day 1 using in-house SAP Systems rich with: Pre-configured SolutionsPre configured Solutions demo-able SAP Functionality Demo-able IT Sapiens custom solutions Framework to develop strawman solutions

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Framework to develop strawman solutions Our “Say-To Do” Ratio is 1:1


Questions ?88

For more information…kindly contact Vijay PisipatyDirector-ERP Solutions & ConsultingIT Sapiens, Inc.e-mail: [email protected]



dea compliance - production and inventory reconciliation

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