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

Index
Synopsis11
Industry Requirements22 Industry Requirements22
IT Sapiens’ Solution Features33
IT Sapiens’ Solution Set44
IT Sapiens’ Solution Features Demo55
Solution Merits66
Our Value Proposition77
1
Questions ?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
3
 Need ability to check quota availability during Purchase Order Release
 Need ability to automatically populate an electronic “DEA Purchasing Logbook”
(Contd…)

 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
4
 Total Samples and Retain Samples quantity withdrawn during Production
 Total Miscellaneous quantity lost during Production
(..Contd…)

 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…)

 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…)

 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…)

 Reporting:
 Need ability to execute a “Inventory Reconciliation in Active Ingredient
 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
8
(..Contd…)

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”

 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…)

 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…)

 Reporting:
 Provides a “Production Yield Reconciliation in Active Ingredient
 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…)

 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
13
 Has served well in easily defending a DEA Audit
(..Contd…)

 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
14
 Movements verified by 2nd User Verification process
 DEA Inventory Log book population at every Goods Movement (Contd…)

 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 UoM
and 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
15
 Ability to reverse Samples Posting and Retain Samples Posting
(..Contd..)

 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
16
(…Contd)

IT Sapiens’ Solution Features Demo
– Master Data
55
 Ability to Maintain DEA Relevant Data in Material Master:
17
(Contd..)

–Functionality Activation and Set Up
55
 Custom Transactions for Functionality Activation and Set up:
18
(..Contd..)

– Approved Quota check in Purchasing
55
 Approved Quota check during Purchase Order Release:
19
(..Contd..)

– DEA Purchasing Log Book
55
 DEA Purchasing Log Book showing details of Quantity Ordered:
20
(..Contd..)

– 2nd Verification during Inventory Goods Movement
55
 2nd Verification Prompt during Inventory Goods Movement:
21
(..Contd..)

– DEA Inventory Log Book
55
 DEA Inventory Log Book showing goods movement quantity in Active
Ingredient Proportion and other details:
22
(..Contd..)

– Production/Process Execution Yield Reporting
55
 Production/Process Yield Reporting during Order-Phase Confirmation:
23 (..Contd..)

55
 Auto Goods Movement Posting from Order Confirmation:
Samples
R iRetain
Samples
GoodsGoods
Receipt
Scrap Goods ReceiptScrap Goods Receipt
To Blocked Stock
24 (..Contd..)

55
 Auto Posting of Samples and Retain Samples Withdrawal from Quality
Inspection Lot at end of Order Confirmation:
Goods
Receipt
Open Q-Stock
to Post
Samples
Retain
25 (..Contd..)
Samples

55
 DEA Production Log Book showing goods movement quantity in Active
26 (..Contd..)June 6th 2015 ©2015 IT Sapiens, Inc.

– Production Yield Reconciliation Report
55
 Production Yield Reconciliation Report showing quantities in Active

– Inventory Reconciliation Report
55
 Inventory Reconciliation Report showing quantities in Active Ingredient
Proportion with Totals per DEA Movement Code and other details:

– Inventory Reconciliation Report
55
 Inventory Reconciliation Report showing quantities in Material Base UoM with
Totals 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 working
C Customers have observed that this solution has helped respond to DEA Audits
successfully
 Functionality involves NO SAP SOURCE CODE MODIFICATION
30

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 andy p g y p
deep 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
31
 Framework to develop strawman solutions
 Our “Say-To Do” Ratio is 1:1

Questions ?88
 For more information…kindly contact
Vijay Pisipaty
Director-ERP Solutions & Consulting
IT Sapiens, Inc.
e-mail: vijay.pisipaty@itsapiens.com
32

DEA Compliance - Production and Inventory Reconciliation

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