Digital SOPs for pharmaceutical manufacturers
Digitizing paper-based operating procedures is one of the easiest ways to improve efficiency and reduce errors on manufacturing lines. For pharmaceutical manufacturers, however, digitizing paper-based processes isn’t always straightforward.
Digital technologies need to meet cGMP guidelines. They must conform to a high standard for data integrity. And they must be secure enough to prevent front-line users from making unintended changes to critical production processes.
Tulip digital SOPs include several features that can help pharmaceutical manufacturers improve efficiency, quality, and visibility in highly regulated facilities. These features are designed to streamline data collection, make compliance a seamless part of the manufacturing process, and secure applications with tightly controlled permissions and approvals.
Similar work instruction applications are already in use in GMP-compliant drug production facilities.
What are Digital Standard Operating Procedures?
Digital SOPs are work instruction applications that guide workers through complex production processes.
Digital SOPs turn difficult-to-read instructions packets into instrumented, interactive workflows. Rich media like photos and videos guide operators through complex procedures. Trigger-based logic automates data collection and progression through a process. And connectivity to IoT devices error-proof processes while increasing visibility.
For manufacturers in all industries, the benefits of digital work instructions include:
- Improved efficiency
- Fewer errors
- Higher throughput
- Better quality
- Higher operator engagement
- Better visibility
Pharma-Specific Features and Benefits
Here are some ways Tulip can help pharmaceutical manufacturers with their unique improvements.
Extensive documentation is a fact of GMP compliance. Records are essential for demonstrating that a given drug meets designated quality standards.
Tulip’s digital SOPs automatically document each step of a process. Operator codes provide a record of the individual who executed the process, and a step-based application format provides a time marker for every step completion. All of the information is stored in no-code tables and is easily accessible when needed.
These records can be exported to create a batch record report and provide a record of process execution and validation when combined with electronic logbooks.
Standardization of Procedures Reduces Risk
Paper-based instructions create the opportunity for variation. Even the best-written, clearest SOPs leave a window for individual interpretations.
In highly regulated industries, these individual variations are a significant source of risk.
Digital SOPs remove the chance of variation. With IoT connected in-line quality checks, these SOPs guarantee that workers are performing every step as specified. If errors do occur, in-app error reports let workers document the problem accurately, at the source.
A common concern with no-code platforms is that an end-user might accidentally change a critical setting. In a validated facility, such changes could have unintended, potentially severe consequences.
Tulip digital SOPs tightly control which users have access to which feature. For example, the engineers creating applications on Tulip will have the ability to author and edit applications. If necessary, the highest level of control can be reserved for IT, who are responsible for integrating and administering the platform. The admins can limit end-users’ power in the platform to running applications in production contexts.
This ensures that digital systems are safe, compliant, and suited to local needs.
Better Quality with In Line Reporting
Mistakes and non-conformances will inevitably happen. While it’s important to prevent them, it’s just as important that they’re documented correctly.
Tulip Digital SOPs let operators report errors in line. Engineers can create custom error report forms for each process, enabling workers to provide the necessary information. IoT connected tools like scales, calipers, and cameras, among others, provide an extra level of in line quality.
Data Integrity by Design
Currently, documentation is a paper-based, manual process.
Documenting processes by hand is inefficient, and doing so by hand increases the likelihood of error, illegible entries, or misfiling forms.
Tulip’s automated data collection ensures that data meets the rigorous standards outlined in regulations. It is protected at workstations, in the cloud, or in your on-premise servers, as well as in transit.
Digital SOPs in Practice: Simplifying Line Clearance on a Complex Continuous Manufacturing Equipment
To understand the impact that digital SOPs can have on production, it helps to look at an example.
A Fortune 500 pharmaceutical manufacturer introduced a complex piece of continuous manufacturing equipment into their production facility. Using paper SOPs, disassembling and cleaning the line’s 16,000 parts took up to two weeks.
Given the high cost of downtime and the higher cost of mistakes, this manufacturer wanted to decrease the time spent performing line clearance and increase the accuracy of workers.
This manufacturer used Tulip to convert their paper SOPs into digital work instructions. These digital work instructions reduced the time workers spent looking for and interpreting the next step.
Previous SOPs were “choose your own adventure” style–meaning that for subtasks, an employee would need to flip back and forth to find the next step. With Tulip digital SOPs, they were able to route to sub-tasks within the application, where the necessary information was immediately available.
By using digital SOPs, this manufacturer reduced their line clearance procedure from two weeks to two days.
A Foundation for Digital Manufacturing in Pharma and Biotech
Digital SOPs are an easy way to increase operational efficiency and ease compliance in highly regulated industries. For pharmaceutical organizations looking to go further in digital manufacturing, digital SOPs provide an easy, quick way to create value, reduce risk, and build digital infrastructure.
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