​The EBR Implementation Guide: Part 4 – Kick-off to Go-live with your 1st Product on EBR in 2 months

The advantages of using an Electronic Batch Record (EBR) in pharmaceutical manufacturing are well known and prove too significant for companies competing in today’s fast evolving business environment to ignore. Transforming from paper to digital however does have its challenges. This article shares patterns we’ve observed that regularly cause projects to run into problems and advises ways to avoid them.

First and foremost, it is fundamental for operations and quality personnel to have the right mindset from the beginning. They must understand the coming changes, their impact, and prepare both themselves and their teams accordingly. Another common issue we encounter is companies not fully understanding their real requirements and capturing them with insufficient clarity and quality. This may sound basic, but it’s amazing how many times requirements change mid-project derailing a project. Finally computer systems validation (CSV), which has evolved with technology, can often become unnecessarily overcomplicated beyond regulatory requirements due to not leveraging the latest methods.

Conquering the following prerequisites will pay dividends in preventing some of these to smooth out your EBR journey.

1. Define your cloud strategy (Multi-Tenant VS. Virtual Private cloud)
The pace of cloud adoption continues to accelerate as pharma manufacturers reap the benefits of its speed, flexibility, and lower costs. Given that cloud needs are tied so closely to business operations and objectives, the journey to the cloud is different for every organization.

There are multiple approaches and selecting the correct one for your company is key. For example, with our Batchline EBR application 2 main cloud architecture options are offered.

• A multi-tenant cloud runs on Microsoft Azure and allows customers to leverage computing resources in a public cloud on a standard application installation. Each tenant’s data is isolated and remains invisible to others. This approach is ideal for organizations with limited in-house security and IT resources because these are provided as part of the service, with exemplary levels of security and IT practices. Configuration and validation complexity is also limited by the high level of standardization, reducing overall project workload on the customer.

• A virtual private cloud, where dedicated cloud resources host only one customer, or tenant, who has sole access. In a single-tenant architecture, the customer has greater control over the management of data, lifecycle, storage, security, and performance. This can also support custom aspects such as non-standard integrations, specific functional developments, or more complicated enterprise IT needs. This suits larger enterprises well, with more complex requirements and the resources to support larger projects. Regardless of the cloud architecture model our customers opt for, Batchline EBR application can be deployed on cloud in less than 2 weeks.

2. Training of Operations and Quality staff
A transition to electronic batch recording (EBR) requires a change in the mindset of all stakeholders (operators, supervisor, process engineers, quality personnel, IT and management). It is important, therefore, for all stakeholders to be aware of the challenges associated with changing human mindsets, element associated with changeand plan sufficient supporting change management to help bring everyone along.

Training is of course provided to ensure that users fully understand how to find their way around the application. But it’s extremely important they put these learnings into practice quickly, especially for people identified as internal champions of the software, who also usually act as trainers later. Very early on, identify key champions & end users who will use the EBR application from the release of the batch record into production, execution of the batch, and review by exceptions, all of which entails a new way of working and benefits from real practical use.

3. Process specification (MBR recipe) design
With Batchline, process engineers develop the MBR design skills through training, coaching, and practice over a 5-day training program. This builds the knowledge and skills required to design product recipes, incorporating key process control data, critical process parameters (CPP), and critical quality attributes (CQA) to validated tolerances, which configure the system to enforce necessary controls when a threshold is exceeded.
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Staffing of these resources is vital to the successful execution of the project and further morefurther enables our customers self-service during the roll-out phase. Self-service capability is what later significantly reduces total customer project time, so building this in the early stages is an investment that will pay off massively later.

4. Batchline application validation
Achieving a compliant cloud-basedcloud-based EBR solution requires well-defined controls and processes, the with shared responsibilities for which are shared between MS Azure, BatchLline, and its the customers. This differs from traditional on-prem CSV in a good way, as it is simpler for the customer, but if your Quality team isn’t familiar with cloud-based validations it’s well worth spending time upfront to familiarize and agree the newer approach to avoid complications later into the project, as they will be the ones signing off to release it for use.

Azure’s infrastructure platform supporting our GxP application is controlled and qualified to an exceptionally high standard, with a plethora of supporting documentation and audit reports. BatchLine setup the environments onto this, and install, configure, and qualify the application under its QMS. So, in the project phase, there is significantly reduced IT and validation activities to perform compared to a traditional on-premise project. The remaining works follow clear pre-defined validation processes and templates to further streamline this work.
BatchLine implement a risk-based qualification and validation approach in accordance with relevant regulations and GAMP guidance. We follow a robust security model and quality practices throughout the various lifecycle phases, including planning, development, deployment, and monitoring. In conclusion, Electronic Batch Records help companies increase profitability and maintain a competitive advantage. A proven implementation methodology using an industry-specific application that understands the operational challenges pharmaceutical and biotech manufacturers’ face, helps deliver this quickly and in compliance with requirements of these highly regulated industries.