In an industry that is constantly evolving, technology is an effective way to improve and enhance those changes. As the FDA becomes stricter with their regulations, the pharmaceutical industry also has to provide new methods to follow those guidelines. The implementation of an electronic system would serve as a very effective method of not only keeping up with those guidelines but providing an audit trail of the ongoing activities within the pharmaceutical company. Some of the top factors that would lead to a successful implementation of an electronic system are proper communication, a dedicated team, and timeline. To ensure the operational aspect of the electronic system, a well created strategic execution design would be another important factor that could result in the success or failure of the project. Over the years, the pharmaceutical industry has become more complex in terms of better equipment and more efficient processes in which medication have also improved and become individualized. This has driven the industry to search for a system that could help with traceability while maintaining the quality of their process.
This paper will provide a set of guidelines and overview on how project management oversee the implementation and validation of electronic systems within the pharmaceutical industry. We will explain in detail what purpose does these computerized systems serve and why is it so important in this industry. In addition, relevant examples that reflect knowledge domains from the project management field will be provided to conceptualize the benefits and risks a project such as this one can undergo. Conclusively, a target audience will also be described to further the understanding of the electronic systems.
The pharmaceutical industry provides research and development for illnesses that can be difficult to treat or might have little to no treatment. So, research is done to provide patients with a way to treat their disease or in some cases cure them. Within the industry, niches can be encounter which focus on specific types of diseases in order to provide the adequate medication these patients need. With the appropriate licenses and approvals from the Food and Drug Administration, they can then go on to commercialize the product by selling them over the counter in pharmacies and provide them to hospitals or any health care facility.
With this in mind, in order for to manufacture medications, pharmaceutical companies have Standard Operating Procedures that explain the steps and guidelines to manufacture them. In the industry, some companies use paper-based system to document any event, process, or even training in order to qualify the staff to produce and test the final drug product. Other companies are evolving into a more technological position in which they use computers to do the same tasks the companies using paper do. Therefore, understanding the factors, benefits, and risks of integrating an electronic system in a pharmaceutical company is very crucial for the project to even be approved.
Ideation and Initiation Phases
This section is where the project is visualized using the ideas and concepts sponsors and stakeholders bring to the table. Understanding the fuzzy front end which pertains to clearing out foggy concepts the project might have would help draw out a path which can be developed to then execute the project. For this case, we will start by understanding some of the prerequisites needed to take on this endeavor. Some knowledge domains such as stakeholder, scope, schedule, cost, and resource management can begin to be identified. For instance, for an electronic system to be implemented in a pharmaceutical company, we would have to know which group is going to be using it and why will they need it? So, the target audience could potentially be Quality Control, Production, Quality Assurance, and Information Technology. These groups will closely work in creating batch records, testing the drug as well as the environment it is being processed in, manufacturing the medication, and providing back up in case there is technical difficulties with the system. Furthermore, we can determine that the stakeholders are the patients, healthcare centers, employees using the system, project managers in charge of controlling the implementation, and business leaders involved in allocating resources and communicating the development to the sponsors of this project.
Some of the benefits of implementing an electronic system in the pharmaceutical company include (Pratik et al., 2011):
- Improved quality of process,
- Enhance onboarding and training curriculum,
- Provide traceability of each activity of the process,
- Find trends and adverse events in a more efficient matter,
- Organization of documents,
- Minimize costs in terms of delays,
- Enhance approval cycles,
- Improve preparedness for FDA inspection, and
- Harmonize processes across multiple branches of the company.
Though these benefits are just scraping the surface of the what it means to have an electronic system in place, it is one with many challenges as well. The challenges include:
- Finding the right electronic system,
- Highly expensive, potential changes in budget,
- Follow validation guidelines from 21 CFR Part 11 (Code of Federal Regulations), issued by the FDA (Pratik et al., 2011):
- Training personnel, and
- Constantly improving and updating the system.
Understanding these benefits, challenges, and how closely stakeholders, sponsors, and leaders will have to communicate and work together to accomplish this project will be the foundation needed to succeed in implementing this project.
Project Cost Overview
In this section, providing an overview of what goes into accurately projecting the costs of the project will be explained rather than providing actual numbers. This is because every electronic system is so different and unique, that it really depends on what the pharmaceutical company wants and the features it needs in order to even start calculating these expenses. Nonetheless, cost management domain will be described in a much deeper sense. There are many tools that can be used to help project a budget and consider issues and sources of funding to control those expenses (Wu, 2020). To implement and validate an electronic system, pharmaceutical companies have to keep in mind security, the size of the firm, developing and maintenance of the system, storage capacity, training, and electronic signatures among others (Pratik et al., 2011). In addition, we have to consider the implementation as well. For instance, how long will it take to qualify the system or even try it out before going live. Furthermore, correcting any issues and creating preventative measures could come at an extra cost. Considering having all the necessary equipment prior and during the implementation of the system can also determine the project success and costs. Stakeholders with experience in building computerized systems may as well work with portfolio and program managers to determine a more accurate outlook of the project cost and budgetary process (Wu, 2020). Conclusively, being able to also set up a cost management plan could reinforce and guide the project team on what to expect (Wu, 2020).
Project Life Cycle
As the project nears the preparation and implementation phases, we need to consider factors that can impact the project’s timeline and execution. For instance, in what ways can environmental, organizational, or project components affect the project? Understanding these components can lead to a much smoother transition between the project and the business process. Within the environmental factors, we take into account the vendor of the system and regular suppliers, the patients that await their medication, inspections from FDA, and employees using the system. The quality and planning in each and every one of these areas must be accomplished systematically in order to maintain relationships and create opportunities that could be beneficial in the future of the company. For the organizational factor we must take into account communication, culture, the approach taken to implement this electronic system, and support. Collaborating and maintaining a great environment within the company can ensure minimal risks associated with the system and prevent confusion or additional work (Pattanaik, 2014). This also promotes and emphasize the engagement of stakeholders and sponsors to avoid chaotic situations that could lead to the failure of the project (Pattanaik, 2014). Lastly, understanding the implications factors such as deliverables, timeline, support, and functionality of the system has on the project can dictate the outlook of this endeavor.
Therefore, a potential project life cycle could be seen as:
- Ideation phase
- Design phase
- Preparation and Initiation phase
- Validation phase
- Revise and Train phase
- Go live phase
This life cycle will cover the project from the moment it was just an idea to the moment it became reality. Each phase would include activities that undergo preparation and improvisation not only from the system but within the company as well. It would take into consideration the factors discussed and the importance of engaging everyone who impact or is impacted by the project (Wu, 2020).
Analyzing Risks in Each Domain
The purpose of this section is to provide additional guidelines and incentive using a few more knowledge domains. It prepares the project team for adverse events that might have not yet been identified. In this section we will focus on resource, conflict, integration, governance, and adoption management. During the implementation of the electronic system, each of these domains carry risks and issues that can be identified. For instance, a risk for resource management in this case is not having the building ready to have this system in place. This brings up the issue of additional costs for construction or equipment to complete this project. For conflict, a risk would be poor training or understanding of the system. This in term creates a lack of motivation among the group of people executing the project. Hence, streamlining the concept would have to be an obligation to avoid conflicting arguments on how the work should be done. When it comes to integration, a risk could be having a tough crowd. Some people may feel that the old ways of doing things was much easier. Therefore, promoting education on the software could result challenging but necessary. A risk the governance domain pose in this project is not following the FDA guidelines. Following regulations is a must do in pharmaceutical due to the fact that you have patient involvement and regular inspections. So, a challenge would be to ensure the system is carried out according to these FDA regulations. Conclusively, a risk the adoption domain would have is the high turnover rate some of these pharmaceutical companies. These can result in a constant team project members replacement which would then delay the project. The challenge here would be maintaining the current members until the project is done. Lastly, as stated throughout the paper, a huge risk a project like this would present is lack of communication. To reinforce communication, it is of utmost importance to meet daily and report.
Connecting the Experience
Implementing a huge project like this means taking time to focus on every aspect that can come to mind. In my experience, being part of the implementation of an electronic system for the microbiology department in a previous job, many of these domains were not considered. Hence, the project stalled and was never completed. Engaging stakeholders and creating a bigger project team would have been a great start (Wu, 2020). In addition, analyzing and preparing the company in terms of resource allocation prior to the initiation phase could have resulted in a different and more effective outlook. However, even though I was inexperience and did not have a proper direction to follow; now, I understand that a successful project is often achieved by planning in a more efficient matter. Sometimes, under so much stress, we forget to apply the knowledge we have.
Luis Quinones is an Associate Scientist who is very motivated to help and work with people. He encourages his colleagues to think outside the box and find more efficient ways to improve processes. His hobbies include reading, working out, and gathering with family and friends.
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Lloyd, K. (2005). 21CFR11: Electronic Document Management. Retrieved from Contract Pharma: https://www.contractpharma.com/issues/2003-01/view_features/21cfr11-electronic-document-management/.
Pattanaik, A. (2014, May 5). Complexity of Project Management in the Pharmaceutical Industry. Retrieved from Project Management Institute: https://www.pmi.org/learning/library/project-management-complexity-pharmaceutical-industry-1487
Pratik, T., Balamuralidhara, T., Pramod, K., Ravi, V., & M.P., V. (2011). Use of Computerized Systems in Clinical Research: A regulatory Perspective. Retrieved from Taylor & Francis Online: https://www.tandfonline.com/doi/full/10.3109/10601333.2011.594443
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