- Bioprocess Software Implementation
- Stakeholders and Requirements
- Software Rollout
- Software Validation
You’ve done the hard part: defining the requirements. You’ve chosen your software and ensured the business commitment to a Bioprocess Software platform. Project stakeholders expect seamless data management and data analytics. Now it’s time for Bioprocess Software Implementation. Here are our top strategies to consider for getting your system up and running effectively.
Stakeholders and Requirements
Poorly handled evaluation efforts create serious issues during every step of your implementation. Proper preparation is key since ill-defined requirements may lead to delayed completion. Get input from all stakeholders: from IT, process development, manufacturing science, to quality and operations. You should carefully check all legacy systems to be integrated and which data analytics functionality is required. Systems interfacing to bioprocess data management and analytics platforms should also be examined. These systems include:
- Bioprocess control software
- Laboratory Information Management Systems (LIMS)
- Electronic Lab Notebooks
The right implementation strategy will ensure that you are better prepared by being able to maintain focus on the original scope of your project and guaranteeing that your employees are properly trained and prepared.
The proper handling of data migration is another important aspect to consider. Evaluate data migration from all sources (legacy databases, spreadsheets, paper based recordings, etc.). For paper based documents evaluate technologies such as optical character recognition (OCR) and document crawling. Migrating all available data into the new system leads to immediate user acceptance after successful Bioprocess Software Implementation.
Document user procedures
Proper understanding of user interactions is essential to setting up the software. Provide users with the documentation needed to navigate the new software environment. Examine and determine the workflow to create documentation of key user procedures. Note that user procedures differ from department to department.
The single-step Bioprocess Software Implementation can be ideal for smaller operations and businesses with up to 100 users. All users are required to migrate to the new system at once. This allows you to focus on your project scope and implementation parameters by offering a simple and straightforward way of handling your processes.
Migrating to a new system step-by-step allows you to implement certain key features earlier while ensuring that possible complications are isolated from working processes.
You should start with the process development department as the system supports process development and stage 1 process validation for one site. Afterwards integrate data from GMP manufacturing. This allows you to cover the required data analytics on scale-up, technology transfers, stage 2 and stage 3 process validation. Based on that you can move internationally by integrating another site. While this approach is more flexible than the single step implementation, it may take longer.
You should consider the required amount of customization to implement a new bioprocess data management and analytics software carefully. Not only are most basic bioprocesses the same for the vast majority of companies, but heavily customized software also leads to higher deployment and operational costs. As many bioprocesses in biopharma and industrial biotechnology are comparable, make sure to weigh customization against potential costs.
Mobile devices are constantly growing in popularity and sophistication. Allowing your users to stay productive when using smartphones and tablets without creating additional security issues should be part of your implementation strategy.
Proper training of your employees may require an investment of time and effort at first but will pay off in the long run. Start training of your employees during migration and rollout and supply them with training resources. Make sure you have chosen a partner for training who understands processes and software.
Follow guidelines, but do not forget stakeholder requirements. Consider basic validation with subsequent GMP validation for relevant data streams and analytics as part of your Bioprocess Software Implementation strategy.
Bioprocess Data Management and Analytics Software
inCyght is a bioprocess data management and data analytics software. It provides out of the box functionality for bioprocess data management and data analytics including certified data interfaces.
Exputec’s complete portfolio of consulting and software solutions with its profound statistical experience in bioprocess development, process validation and direct interactions with regulatory authorities.