Introducing AWI: Pharma Authoring Made Effortless
- Published:Sep 22, 2022
- Category:Augmented Solutions
What Are Augmented Work Instructions?
Augmented work instructions are a tool for streamlining the way workflows get created and executed. In the pharmaceutical manufacturing industry, augmented work instructions are a modern solution for authoring and executing recipes and procedures.
Instead of needing to manually record and transcribe every step on paper, manufacturers can use AR technologies to digitally manage, iterate, and execute their procedures.
Why Are Augmented Work Instructions Necessary in Pharma?
Recipe authoring by using paper or “paper on glass” tech is akin to playing the game of telephone — a lot gets lost in translation. But it doesn’t have to be this way.
So, what’s the problem with paper? Using paper to create and implement pharmaceutical recipes can lead to a number of challenges, including:
- Transcription errors. Typos and misspellings are inevitable, but especially likely when researchers need to record and transcribe recipes by hand.
- Data overload. Since process scientists tend to author multiple recipes at once, papers can pile up and sit on their desk for days, or even weeks, waiting to be reviewed.
- Data management issues. All authoring data needs to be archived and maintained, which gets arduous and time-consuming when it’s bound to paper files.
- Burdensome form factor. During execution, paper recipes require operators to switch between binders and their manufacturing operations.
- Knowledge transfer cycles. Any time a drug switches between manufacturing facilities, all the information needed to manufacture it needs to get transferred, which is no easy feat when everything’s on paper.
Augmented work instructions can resolve these challenges by reducing the time and resource burden that’s tied to paper. In addition, AWI with intuitive no-code UX puts power back into the hands of scientists and engineers by letting them author the recipes themselves.
“When you’re handing off your batch record to a separate person to author instead of the scientist themself, a lot gets lost in translation. You end up needing to spend extra time, extra resources, and extra money.”
— Emilee Cook, Product Lead, MES, Apprentice
In the pharmaceutical industry, augmented work instructions can help manufacturers achieve clarity: saving them time and money while reducing the likelihood of errors. And that’s exactly why we’ve launched our new AWI package.
Introducing AWI for Pharmaceutical Manufacturers
We’re excited to present our latest package, Augmented Work Instructions (AWI). AWI is an interactive work instructions builder and procedures builder that lets you collaboratively author and execute pharmaceutical recipes on the go.
AWI is the only cloud-native, digital work instructions software built for the needs of your pharmaceutical facility.
AWI gives you the power to:
- Author procedures digitally: Empower your scientists and engineers with no-code, intelligent process design, so you can Create digital procedures in hours — not weeks.
- Execute where you are: Work on the floor with our cloud-native mobile app and hands-free, voice-enabled headset that is ATEX-certified, cleanable, and suited to PPE.
- Build quality into execution: Expedite reviews of quality events with review-by-exception and workflows, and minimize release delays with paperless, built-in data integrity checks.
- Grow with your operations: Let your growth dictate your transition to our Tempo MES platform, which can pave the way for you to build a connected enterprise across teams and sites with Tempo’s Manufacturing Cloud.
AWI’s Pharma-Specific Functionalities and Benefits
Our AWI was built specifically to support pharmaceutical manufacturing:
- Devices designed for operators, wherever they work. AWI can be used on phones, computers, and wearable headsets, letting you bring digital instructions onto the production floor.
- Secure and compliant with the regulatory standards. AWI is GxP and GMP-ready, and has a validation pack with IQ and OQ included.
- Optimized for use in pharma environments. AWI devices are cleanable, rugged, and ATEX certified — meaning they can be used in the suite, cleanrooms, and while wearing PPE.
- Can safely capture signatures. Leverage an electronic signature system that is compliant with 21 CFR Part 11 and uses unique pin codes to make credential entry efficient.
- Built to decrease non-conformances. Build in conditions, exceptions, and guardrails to reduce quality non-conformances and easily review and release by exception.
AWI in Action: Use Cases
Want to see our AWI in action? Check out all the ways you can make AWI work for you:
Electronic Batch Records
Our AWI lets you digitize your batch records, turning them into electronic batch records, or EBRs. This lets you reduce errors, process material, and manufacture faster on a digital system.
Digital SOP Management
Manage, iterate, and execute all procedures, including standard operating procedures or SOPs, with ease. Our work instructions builder lets you easily create and keep track of all your digital procedures.
Provide just-in-time training on mobile tablets and wearable headsets. This will make right-the-first-time execution a reality, not just an aspiration. By adding technique media to your SOPs, you can fine-tune your guidance with engaging, interactive digital work instructions.
Use AWI to digitize all of your line clearance forms, resulting in faster turnover and documentation. Our AWI lets you ensure work areas are properly turned over, helping you get the most use out of your time and equipment.
With our Life Sciences eLogBook functionality designed specifically for pharma, you can track usage and current statuses of equipment. Make logbook management a snap and streamline reviews by easily storing a complete log of an executed procedure, including exceptions and overrides.
Setting the Foundation for Tempo MES
You can purchase AWI on its own, or bundled with other packages in our Tempo Manufacturing Cloud.
With our Tempo Manufacturing Cloud, you tap into a powerful, easy-to-use system that’s simple and intuitive. It’s also fully integrated with all the systems needed to accurately record and transcribe data across teams. Plus, it’s cloud-based, so all the information is readily available at your fingertips, when you need it.
The benefits of using Tempo for recipe authoring and execution include:
- No-code scripting: Built with end users in mind, Tempo features a simple form builder style that’s familiar, enabling teams to scale batches and expedite the transition from preclinical to clinical and commercial.
- Seamless troubleshooting: Quickly test a draft procedure for accuracy and troubleshoot as needed.
- Live group editing: Test methods and make amendments collaboratively, without needing coding expertise from software engineers.
- Document digitizing: With its unique AI, Tempo transforms paper (and other paper-like documents including PDF and Word) into digital format.
- Execute collaboratively: Execute procedures and batches individually or as a team, where different users can own individual steps. Complete steps and update values in real time so everyone is on the same page.
- Obtain operational precision: Operators can follow audio or text instructions enhanced with photo, video, and AR overlay directions that are specific to the equipment and layout in their suite to make instructions crystal clear.
Tempo combines both manufacturing and lab execution systems, optimizing for speed and accuracy. Plus, it allows your team to operate in real time from a single shared system, making the recipe authoring process simple and straightforward.
You’ve Got Questions, We’ve Got Answers
Want to learn more about how Tempo can help you accelerate recipe authoring and reduce time-to-market? Feel free to drop us a line — our team is here to help.