Upsher-Smith: Big, Bold, and Unified Manufacturing ... · Upsher-Smith Laboratories, Inc. LLC Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives

Upsher-Smith: Big, Bold, and Unified Manufacturing, Quality, and Regulatory

Tracy Dahl

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Confidential

Speaker

Tracy Dahl, Manager

Centralized Document Management

Praised by leadership and various clients for her positive can-do attitude, Tracy has over 25 years of document control experience in the Pharmaceutical Industry. Her time in the military served as a foundation for being a committed leader and is the driving force behind her management abilities. Tracy currently manages the Vault QualityDocs and Vault QMS at Upsher-Smith Laboratories.

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• Upsher-Smith Background

• SAP Integration

• Lessons Learned

• Looking Forward to a Unified Future

• Q&A

Meeting Agenda

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Upsher-Smith Laboratories, Inc. LLC

Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth.

Since 1919, we’ve formulated and manufactured specialty generics for a wide array of customers, backed by our attentive level of service, our strong industry relationships, and our dedication to uninterrupted supply.

• HQ in Maple Grove, MN; production plants in Plymouth, MN and Denver, CO, satellite in Princeton, NJ

• Founded in 1919 by English chemist F.A. Upsher-Smith

• Owned by the Evenstad family from 1969 to 2017

• Acquired by Sawai Pharmaceutical Co.,

Ltd. in 2017

• Approximately 650 Employees

• US commercial focus in generic and brand drugs

• Neurology sales team with patient-access focused commercial platform

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Challenges

• Inefficient processes

• Risk from manual overhead

• Limited visibility with disparate systems

• Too much support needed for the users

• Difficult to integrate systems

• Applications were not very intuitive

Existing Solutions

Legacy

Systems

PaperSpreadsheets

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Upsher-Smith desired to deploy:

• Comprehensive electronic quality management system (Vault QMS)

• Document management (Vault QualityDocs)

• Regulatory information management system (Vault RIM)

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Our Vault Story: Business Goals

Veeva delivers:

• Credible and qualified software solution

• Efficiently manages quality and regulatory elements

• Allows for more robust and timely data reporting

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Our Vault Story: Business Drivers

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Intuitive and consistent user

experience

Flexible and scalable for future business needs e.g. vendor

management

Integrated quality processes capturing

metadata

Reduce paper and streamline by moving

electronic

Integration with corporate systems: SAP, Content Server,

Office365, LMS

Business intelligence tools allowing robust analytics, e.g. APR

Global, authoritative source of product registration data

Submission planning and tracking,

product registrationmanagement

QMS processesCAPAs, change control, customer complaints, and deviations

Centrally capture cGMP documentationE.g. non-conformance investigations

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What have we gained?

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Timelines

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6 weeks

Implementation

12 weeks

16 weeks

In Progress

Document Types

• Refine document types, subtypes, and classifications

Fields

• Refine fields for each document type

Workflows and Lifecycles

• Review the lifecycle(s) and workflow(s) through which each document type passes

User Security and Access

• Refine user groups, and access levels

Reports

• Define structure, format, and access for reports

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The Building Blocks for Configuring Vault QualityDocs

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The Building Blocks for Configuring Vault QMS

Current State and Use Case

• By process group

Data Set Up

• CAPA

• Deviations

• Audit findings

• Product complaints

Notifications

• Messages

• Event triggers

User Security and Access

• Refine user groups, and access levels

Reports

• Define the structure, format, and access for reports

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The Building Blocks for Configuring Vault RIM

Registrations

•Review objects and fields: registration; product; packaging

Submissions and Maintaining Registration

•Application/ submission

•Impact assessment/ events / activities

Security

•Security profiles

•Security rules

Reports and Dashboards

•Review standard reports

•Define custom reports

Configuration Verification

•Configuration demo and confirmation

Registrations Orientation

•Orientation to registrations

•Terminology / basic training

•Discussion of client processes

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SAP Integration

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Requirement: Vault should provide the ability to:

• Accept data from SAP to be used in Vault drop downs or picklists

• Allow SAP to query information collected in Vault

Launched:

• SAP pushes materials, batches, and equipment to Veeva

• SAP queries Veeva for batches within product quality event (PQE)

• SAP transactions were modified to use Vault information pulled back from queries

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SAP Integration Goal: Increased Batch Compliance

SAP and Vault QMS Integration

RE

ST

AP

I

Batch Holds used in:

Change Controls (QE)

Deviations

Materials, Batches, Equipment Object s

(product __v)

(context__qdm)

(equipment__c)

Created new

transactions to push

Batch Disposition

By QA person

QA person

releases product

(Official Release)

Query PQEs

*Batches on PQEs

Available in

Picklists

and/or Objects

*SAP gets information from VaultConfidential15

Integration | Disposition

QA Disposition

• Decisions available are:

- Accept – Batch can be released

- Reject – Batch cannot be released

- Remove – Batch removed from record

• SAP pulls all batches on all PQEs regardless of disposition

- In Veeva, disposition is blank and then is populated after disposition

• Disposition is then updated within SAP to allow for QA release

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Things we might do differently:

• More Time – Spend more time on roles, responsibilities, and security/permissions

• Take Training – Take the Vault Administration Training earlier in the process

• Leverage Experts Early – Bring the internal expert for SailPoint single sign-on (SSO) onto the project as early as possible

• Validation testing – Ensure key pieces of the system are negatively tested (especially security/permissions)

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Lessons Learned

Benefits

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• Reports and dashboards

Greater visibility

• See status and owners of tasks

• Increased search functionality

Self-sufficiency

• Single, unified management of quality processes and content

Unified quality management

• Single place for product registration data

Global authoritative source

• Integration with SAP for batch disposition process

Seamless batch disposition

• Seamless processes across quality and regulatory

Anticipated benefits

• Intuitive

• Easy to find information

• User homepage

User-friendly

• Easily make changes to align with the business

Flexible

Future Vision of Veeva at Upsher-Smith

• Vault Submissions project underway

• Master batch records are up next in progress

• Facilitate the transfer of quality and regulatory system information to / from third-party organizations

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Future State: What’s Next?

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Future State: Connecting Quality and Regulatory

Which products are

impacted?Does the change

require regulatory filing

updates?

What is the status of the

regulatory filing

updates?

Linking change to

regulatory filing updates

Continue to evaluate what is going into Veeva:

• Internal Audits

• External Audits

• Annual Product Reports (APRs)

• Vendor Evaluations (Audits)

• Vendor Scorecards

• Supplier Quality Notifications (SCARS)

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Future State: What’s Next?

Q&A

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Tracy Dahl, Manager, Centralized Document

Management, Upsher-Smith

Let’s Network!

Upsher-Smith: Big, Bold, and Unified Manufacturing, Quality,

and Regulatory

Tuesday, September 18

8 – 8:30 a.m.

Braindate Lounge (4th floor)

SIGN UP IN

BRAINDATE

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APPENDIX

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QMS & QualityDocs Timelines:

Implementation

Weeks 6-10 weeks (Pending Scoping) 8-14 weeks (Pending Scoping)

VA

ULT

QU

AL

ITY

DO

CS

PLANNING

SOLUTION

REVIEW &

CONFIGURATION

TESTING

SUPPORT

TRAINING &

DEPLOYMENT

VA

ULT

QM

S

SOLUTION

REVIEW &

CONFIGURATION

TESTING

SUPPORT

TRAINING &

DEPLOYMENT

POST-

PRODUCTION

SUPPORTMANAGED SERVICES

Go-Live QualityDocs

Final

Plan

Vault QualityDocs

Configuration

Validation

PreparationPQ

Training

Preparation

Train the

Trainer

Vault QMS Configuration

Validation

PreparationPQ

Training

Preparation

Train the

Trainer

Go-Live

QMS

Implementation Support

Weeks 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17+

VA

ULT

RE

GIS

TR

AT

ION

S

PLANNING

SOLUTION REVIEW

& CONFIGURATION

MIGRATION

TESTING SUPPORT

TRAINING &

DEPLOYMENT

SUPPORT

VA

ULT

SU

BM

ISS

ION

S

PLANNING

SOLUTION REVIEW

& CONFIGURATION

MIGRATION

TESTING SUPPORT

TRAINING &

DEPLOYMENT

SUPPORT

Plan

Solution Review

Configuration

Prepare for Data Load Data Load TestingProd

Load

Validation Preparation PQ

Develop

Materials

Plan

Train

Go-Live

Managed

Services

Solution Review

Configuration

Prepare for Data Load Migration TestingProd

Load

Validation Preparation PQ

Develop

MaterialsTrain

Managed Services

Go-Live

Submissions and Registrations Timelines:

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