PEPPERDINE UNIVERSITY
THE GEORGE L. GRAZIADIO
SCHOOL OF BUSINESS AND MANAGEMENT
JOHN P DURAND
ISTM 654.32
INFORMATION & PROCESS SYSTEMS
FALL 2012
MONDAY
6:00 PM – 10:00 PM
ENCINO GRADUATE CAMPUS
An analysis of Implementing Electronic Batch Record System in a Biotech Company
Goyal, Vinay
Miskopy, Bita
Montanez, Vanessa
Poladian, Maral
Salib, Carolyn
November 19, 2012
Introduction and Business Strategy
Despite the advances in technology, many biotech and pharmaceutical industries continue to rely heavily on paper-based batch records. Batch records are used to document the execution of manufacturing processes in a current Good Manufacturing Practices (cGMP) regulated environment. Batch records make up the entire batch history of a product including all the specifications, information, data, graphics, equipment, guiding procedures, instructions, special labeling, special personnel training, safety, product approval and release, and other critical parameters that are recorded and retained. Year after year, Food and Drug Administration’s (FDA) emphasis on “risk-based approach to 21 CFR” has made the industry more stimulated into transitioning towards electronic batch records (EBR). Paper-based batch records have caused high levels of FDA scrutiny and non-compliance since manual documentation is highly prone to transcription and calculation errors.
We live in an age where technological innovations are appearing almost daily and this evolution of automated business practices are changing the way many organizations do their business. Once such big innovation was the introduction of Enterprise Resource Planning (ERP) systems, such as Oracle and SAP. These software packages allow the company to electronically track their entire production process from start to finish, integrating all relevant processes alongside, from suppliers to warehouse storage and everything in between. The economic effects of utilizing such systems have been proven to be very dramatic, saving companies thousands to millions of dollars. This paper will discuss a strategic approach to implementing EBR. Our analysis includes a review of the following factors: identification of weaknesses of paper-based batch records, compliance with FDA regulation, effect on employee morale, improved product quality, and optimal customer satisfaction. With revenues of 73.5 billion Euros, Siemens is a global company who continues to operate using a paper-based batch system. Electronic batch recording would enable Siemens to operate more efficiently as well as reduce costs associated with batch systems.
Business Problem
With the wave of such technological innovations introduces the idea of Electronic Batch Records (EBR). Currently, Siemens Healthcare Diagnostics is using paper based batch records. For instance, in order to manufacture Product A, batch records are printed or copied and distributed to the necessary operating divisions. Then, users begin the process of hand recording every entry on the paper batch record. Batch records can be compared to recipes used while cooking. Therefore, it is imperative that the exact measurements of the ingredients are added to ensure an accurate batch or end product. Batch processing is closely regulated by the US Food and Drug Administration (FDA) and companies who are non-compliant with such regulations bear heavy financial and regulatory consequences. Siemens requires that every single step in the batch process to be signed off and dated by the operator, and in many cases by a supervisor as well. Manual batch records tend to have a higher potential of human error. Common errors include incorrect or missed entries, dates, times, approvals, and calculation errors. Such data discrepancies effect the authentication of the batch records and effect employee productivity. At times, employees can fill out 200 plus page batch records. This process includes verifying whether the raw materials and equipment are available for production use, ensuring that every single step is initialed, and flipping through the pages is cumbersome and laborious. Many of these production processes are dependent on other processes as well as users/operators. When one person is not available at a critical moment in the procedure, the implications can be significant. In laboratories such as Siemens, there are instances when a loose paper is misplaced or damaged due to spill of lab materials such as chemicals or liquids, such outcome can be very demoralizing to the employee. Such errors may appear to be minor issues, however, it can cause many problems and may even lead to non-compliances in the organization. One of the immediate benefits of utilizing an EBR system is that it eliminates most of these problems since the controls are integrated in information technology system. A complete set of work instructions, procedures, material safety data sheets (MSDS), raw material and equipment availability are examples of common components that are displayed online and are available in real time for all operators to view. Although the process of manufacturing Product A is written in a sequential order, paper based batch records cannot “force” the operator to document and make entries in real time. Often times the operator continues the process and saves the transcribing until after the process is done, which may result in missed entries. On the other hand, EBR forces sequential and continuous execution of the process. Other problems that may result from using paper based batch records are calculation errors; it is easy to make mistakes when manually entering calculations, whereas, in EBR calculations are very easy to control. Another big problem that the company faces is that in order to digitize, archive and retain the paper batch records documents they spend over $400,000 annually. It is required by law to retain such records for the life of the product.
It is somewhat easy to recognize the economic effects of utilizing automated services such as EBR; it will reduce cost in the long run, improve quality, reduce cycle time, and increase productivity, however, we cannot overlook the human impact of introducing such a huge change in the company. Over the course of our research, our consulting firm surveyed a number of Siemens Healthcare employees to gain some insight on their thoughts on implementing an EBR system. Employee satisfaction is important in any organization and employee involvement or excitement in this process can prove to be very beneficial for the overall organization. More specifically, it is the employees who are going to use the system and interact with it, and if you don’t have their buy-in you may cause more harm than good. Interestingly, our survey results show that most of the employees we spoke with are ready to move towards an EBR system. Furthermore, they recognize how the adoption of EBR can increase the efficiency and ease of their daily tasks, the compliance factors, and realize the long-term benefits of EBR. There were also a few employees resistant to the change. It was interesting to find that the employees who express resistance to the change were “older” employees. Although they recognize the benefits, they questioned the ease of use of the new system and were not shy to admit that they are somewhat intimidated by it all. However, they did mention that they are willing to participate in the training and learn how to utilize the system. This level of readiness to change is based on a recent positive experience that employees had when SAP was implemented about a year ago. Even though there were few glitches, management provided the necessary training and tried to mitigate problems. The overall experience left a positive impact on employees.
Regulatory Requirements
All FDA regulated companies must comply with cGMP and FDA’s 21 CFR guidelines. For biotech, medical device and drug manufacturing companies, accountability and compliance are an important part of quality and safety system management. When EBR was first introduced over a decade ago there were many glitches of compliance with the FDA regulations, therefore, FDA allowed the use of EBR only as a manufacturing support system and not a replacement for paper-based batch record. Software vendors worked hard to make sure all the characteristics of their systems captured the FDA regulations, especially Part 11 of Title 21 of FDA, where the requirements will allow electronic signatures to be accepted as the equivalent to hand signatures. The requirement by the FDA for using EBR is that “recipes must be run as they were designed”. EBR system enforces proper sequencing during the production process. For example, if there has been a past deviation in the process, the system requires a “security clearance” before the operator is able to move on to the next step. Other regulatory requirements include purchasing controls. This is where manufacturers are obligated to evaluate and select potential suppliers on the basis of their ability to meet specified requirements set by the FDA and other regulating agencies where applicable. Another requirement is the control of all measuring and test equipment and devices, which ensure that equipment is routinely calibrated, inspected and maintained.
Another requirement of an EBR system, is a signature manifestation. “Each record must contain adequate event detail. All signature-controlled EBR records must clearly indicate the printed name of the signer, the date and time of execution and the meaning of the signature, such as whether it indicates review, approval, responsibility, or authorship by the person. Each electronic signature must be unique to one individual and shall not be reused by, or reassigned to anyone else”. (US Food and Drug Administration: 21 CFR 820)
The FDA closely observes the software packages and how they are applied to the company’s business practices. In addition to having an EBR software package that is FDA compliant, it is imperative that an organization also implement controls specific to the business. Controls are used to ensure continuous compliance maintenance. In some cases, the software package passes FDA compliance but subsequent to its implementation, its compliance status may change. Prior to proposing a final software recommendation, we considered various software features to ensure the software would be the best match for Siemens Healthcare. This was an important factor which shaped our decision making process. Throughout this review process, we researched several options to identify which software would be the best match and most beneficial to the company. This paper will also discuss three different software packages that appear to meet the criteria and needs of Siemens. Ultimately, the goal is to identify a suitable package, which will enable Siemens to achieve a competitive advantage.
Business Process Redesign
After analyzing the existing process, the problem, the requirements and the necessity to change, we concluded that successful change can be achieved by utilizing information technology, however such a change requires Business Process Management skills and according to the recommendations of Lauden and Lauden in their book, Management Information Systems, the following steps are needed to achieve the objective:
1. Identify the process to change – the impact it will have on business performance
2. Analyze existing processes – detailed sequence of activities and the resources needed
3. Design the new process – comprehensive comparison of the old and the new model
4. Implement the new process – involve users of the new process to identify needed improvements
5. Continuous measurement – To maintain effectiveness
Competitive Advantage
Competitive advantage is the strategic advantage one business entity has over its rival entities within its competitive industry Achieving competitive advantage strengthens and positions a business better within the business environment. (http://en.wikipedia.org/wiki/Competitive_advantage).
Interestingly, there are a small number of competitors in the field of Electronic Batch Record systems. For Pharmaceutical companies, accountability and storing of data are crucial. In particular to our research for Siemens, a better competitive advantage can be gained in the form of removing written batches and formulas which are labor and time consuming but by using electronic batch records. With today’s technology, there are several software options for Siemens Healthcare to choose from. Common EBR software include, Batch Master, InstantGMP, Master Control, Mar-Kov CMS, Recipe Manager and Syncade EBR.However, due to our expertise with this software, we have identified the top three software and have included a short summary on the included features.
EBR Comparison
Prior to making our final software proposal, we examined several EBR softwares. Reputation of the vendor, system updates, and technical support are a few of the criteria factors we examined to make our final proposal. A further explanation of all the criteria we examined is as follows:
Research the reputation of the vendor:
This would include checking the vendor’s track record, history, and portfolio while reading as many references and testimonials as possible. We also looked at the software currently used by Siemen’s competitors. This information provides an organization with information on the transaction volume and capacity that the software is able to process (http://ebatch.net/).
How frequently does the vendor update their technology and portfolio?
The level of functionality Siemens will need for the initial start-up of their EBR is relevant. Technology is constantly updated and changing; the sophistication of the technology tools used by the vendors must adhere to FDA rules and regulations. Data must be updated in a secure environment (http://ebatch.net/).
What types of continued support are provided?
Every vendor must understand that new security holes and viruses are constantly discovered in web applications, even after testing and launch. Therefore, continuously updating and training Siemens site with security patches is required. Each vendor should present some contingency and plan to keep applications up to date with regulations and compliance (http://ebatch.net/).
Training:
Since the majority of Siemens information on EBR will change, someone from Siemens IT employee should be trained to handle minor issues such as how to fix broken links or update new pages. But, if more severe problems arise, the vendor would need to be available for support 24/7 (http://ebatch.net/).
Inventory Control:
Supervision of the supply and storage and accessibility of items in order to insure an adequate supply without excessive oversupply is important for electronic batch records. When compiling the recipe required ingredients are key for completing the formula. By having inventory control you will be able to complete the process (http://en.wikipedia.org/wiki/Inventory_control).
Purchasing:
This provides information if the ingredients are in stock. Ingredients are qualified and tested under FDA regulators. This is an important factor when deciding which vendor to select. Purchasing may also involve (a) development and review of the product specifications, (b) receipt and processing of requisitions, (c) advertising for bids, (d) bid evaluation, (e) award of supply contracts, (f) inspection of good received, and (g) their appropriate storage and release (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.50).