Electronic Batch Record SystemsVinay Goyal

Bita MiskopeyVanessa MontañezMaral Poladian

Carolyn Salib

November 26, 2012

Outline Introduction Current Situation / Business problem Business Strategy: Electronic Batch Record (EBR) System Regulatory Requirements Capital Budgeting and ROI Effective Business Process Selection Criteria Competitive Advantage Request For Proposal Overall Arching Benefits: Pros and Cons and Ethical

Aspects of Implementing EBR

Project ProposalImplementation of electronic and automated batch record system within Siemens Healthcare Diagnostics

Who is Siemens Healthcare?

Company Background

Siemens AG: Fortune Global 500 Over 450,000 employees globally 65,000 employees in US: in all 50 states € 73.5 billion global sales Siemens Healthcare:

Over 900 laboratory diagnostic tests

Healthcare is shifting in focus from treatment to prevention, mostly as a result of emergence of biotechnology

There are more than 400 biotech drug products and vaccines currently in trial targeting more than 200 diseases including some cancers

Biotechnology is responsible for hundreds of medical diagnostic test that keep the blood supply safe from HIV

Biotech industry has mushroomed since 1992 US healthcare revenues (from publicly traded companies) rising

from $8 billion in 1992 to $59 billion in 2009

Biotech processes has dramatically improved criminal investigation and forensic medicine

Biotechnology Industry: general facts

What is a batch record?One big recipe!

Components of a BR – to name a few… Product Name Company Name Date of Manufacture Expiration Date Storage Conditions Materials/Ingredients/Equipment Used Step-by-Step Processing and Testing Signatures Required

They accompany the batch of a product throughout all phases of manufacturing

Background and Introduction Evolution of technology and automation has changed the

way we do business today

Yet, most biotech, drug manufacturing and pharmaceutical companies do not use paperless systems

Movement toward electronic systems is slow

One of the main reasons is that it is extremely difficult and risky to be in compliance with CFR Part 11

Organizations don’t want to risk regulatory liability exposure

Why Regulate? Significant events have shaped the

regulation of biotechnology and pharmaceutical industries by the Federal Food and Drug Administration (FDA) 1912-Mrs. Winslow’s Soothing Syrup

for teething babies, laced with morphine killed many infants

1962-Thalidomide, a new sleeping pill, was found to have caused birth defects in thousands of babies born in Western Europe

Why do Regulations Exist To protect the public health and safety!

It’s no more complicated than that!

Some Regulatory Agencies Federal Food and Drug Administration ISO 13485 Good Manufacturing Practices-cGMP (Guidance) European Directive 98/79/EC German Act Canadian Regulations SOR/98-282 Japanese Ordinance Act

What is 21 CFR Part 11

Federal regulation that describes how a FDA regulated industry creates, maintains, retrieves, modifies, and archives electronic records

Establishes criteria for the use of electronic records and electronic signatures to comply with predicate rules on records.

What is cGMP Current Good Manufacturing Processes

Enforced by U.S. Food and Drug Administration

Lack of cGMP compliance may result in a number of regulatory actions taken against the organization

Business Situation/ProblemSiemens Healthcare Produces Paper and Diagnostic Tests

Analysis of Current Situation Study current processes and workflow

Review any deviations in the process

Review cycle time

Review internal and external audit reports

Study cost of operation

Study the visibility of the supply chain, inventory, and availability of equipment

Business Situation/Problem Batch operations are conducted manually

Time consuming. Too much paper to handle Every step has to be signed and dated by the operator In many cases by a supervisor too

Inefficient Inherently slow, cumbersome and error-prone

Poor Tracking A serious problem in case you need to identify defects Physical tracking of logs, records, test results

Business Strategy: EBR Implementing Electronic Batch Record (EBR) System

Electronic Batch Record It provides for

Complete history of a production batch Identifies all materials and data Operator interactions Electronic signatures Quality due-diligence information

Collection of information required for reporting to Quality Assurance Food and Drug Administration Customers

Business Strategy: EBR Implementing Electronic Batch Record (EBR) System

Put together Work instructions Formulations Processing information List of ingredients Applicable specifications Measuring and test equipment information Records Compliance and regulatory requirements

Competitive Advantage Siemens currently is using written batches and

formulas Electronic Batch Records will provide a competitive

advantage Save labor and time Create consistency and accountability Able to track and measure

EBR Vendor Comparisons

Type a brief overview or summary ofyour project here.

Batch Master InstantGMP Mar-Kov CMS NeoDyne Master Control SYNCAD

Sytem Client/Server Web Client/Server Client/Server Client/Server Client/Server

Inventory Control yes yes yes no no yes

Purchasing no yes yes no no no

Equipment Log no yes yes no no no

Part 11 Compliant no yes yes no yes no

Audit Log no yes yes yes no no

Totals yes 1 5 5 1 1 1

Vendor Criteria1. Research reputation of the vendor2. How frequently does the vendor update technology3. What types of continued support are provided4. Other Categories outlined on table

Best Vendor Criteria5. Instant GMP6. MAR-Kov CMS

Request For Proposal (RFP) Industry Summary

Siemen’s “Agenda 2013” - New 2 year global initiative aimed Improving Sector’s competitive position Expanding its capacity for innovation Higher expenses in R&D and SG&A YTD revenue for Healthcare increased 8% compared prior year

EBR Overview Use of EBR systems is more prevalent in the Healthcare

Industry Streamline manufacturing processes Improving regulatory compliance System efficiencies Cost savings

Approach

Facilitates best practices in production and manufacturing

Increase accuracy in logs, inventory, bill of materials Optimizes resource utilization Decrease overhead Reduce product variation and defects Increase margins and cash flow

Results Best Vendors based on our analysis GMP and MAR-Kov CMS IT adoption process will enable Siemens to substitute paper

based system with automated electronic manufacturing process

Increase compliance with regulatory agencies System would present an intuitive, navigable and easy to

learn interface with its users System flexible and configurable process with improved

product quality and safety. Quality checks and built in security

SWOT of EBRStrengths

• Dedicated workforce• Previous success with other

implementations ( SAP)• Management commitment • Training

Weakness Older generation workforce

reluctant to change Disruption during transition Not enough workforce to

transfer manual procedures into EBR system

SWOT of EBROpportunity

Improve FD compliance Efficient and quicker data Improve information

sharing More opportunities for

employment

Threats Demand for hiring trainers

can be rejected by management

Can surpass budget – costs Workforce can be reduced

as EBR becomes efficient Workforce disruption can

cause customer complaints and loss

BenefitsSince the adoption of computers we have been able to simplify our lives and make our work easier and more accurate: Benefits of Electronic Batch Records Include:

• The EBR system increases the speed of production because electronic batch records are easy to update, transfer, and review. 

• Efficient retrieval of information: with information in a digital format it is fast and easy to retrieve information saving time and manpower.

• Increased productivity- with EBR less time will be spent collecting the various components of the batch record from different departments.

Benefits Cost avoidance- batch records must be retained for at least

two years after the expiration of the product. However, use of EBR can eliminate the need to allocate resources to the storage

• Increased speed of product changes and product introductions- use of EBR in the development process will lead to greater efficiencies in new drug implementation and applications

• Better documentation- Doctors are legendary for illegible hand writing leading to inaccurate data entry by a second or third party.

Change Management and Affected Business Process

Implementation has a huge impact on employee behavior and organization

Resistance from employees may hinder the success of an adequate system implementation

Need to identify and address potential employee concerns

Systems analyst: acts a leader throughout the process

Employee Participation High level of management support Employee participation: opinions are heard and taken into

consideration - afterall, employees will use system Advantage:

Improved employee morale Changes are not a surprise

Lack of participation: Gap between end users and IT specialist Employees are not excited about transition and are

not on board

Capital Budgeting Review cash inflow and outflow of the project Investment costs: hardware, software and labor Cash inflow: increased sales of new products and

improved quality Cash outflow: cost of new software & training Cost savings: reduced costs and employees can

allocate their time towards different projects (Agenda 2013)

Return on Investment Used to determine whether or not to move forward with

the project

Cost of Software: $40k to $1 million or 54k to $1.35 million Euro

Cost savings: reduced cycle times, improved accuracy and consistency of the batch records, reduced cost of compliance, increased productivity, increased speed of new products to the market, and increased customer satisfaction

Return on InvestmentFactors included in ROI Cost of EBR software Increased payroll expense or cost of training Potential gain from implementation

New projects Improved efficiencies

ROI = Gain from investment – CostCost

or 5.8 million – 2.3 million = 1.5 2.3 million

Successful Implementation Keys for successful implementation Phase I

Pre-Assessment Review Readiness and Scope Time: 3 to 5 days

Phase II Documentation Guidelines for Batch Records Change Control and Implementation Pilot Testing Time: 12 to 18 weeks

Phase III Harmonization of Supporting Documents and Processes Change Control and Implementation Pilot Testing Time: 12 to 26 weeks

Phase IV Go Live

Thank You!That wasn’t bad wasn’t it?

Works Cited US Food and Drug Administration: 21 CFR Part 11 US Food and Drug Administration: 21 CFR Part 820 www.siemens.com/answers Allen, Paul B. Electronic Batch Record Management in the

Pharmaceutical Industry. 25 March 2003 Electronic Batch Record: Who Says You Have To Live With Shrinking

Margins.12 Jan. 2004 Laudon, Kenneth and Lauden, Jane: Management Information

Systems. 2012.