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Real-Time Visibility: Needs & Solutions

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June 16, 2022

Industry Perspective

Real-time visibility is a priority for many industries, but it is especially crucial in pharmaceutical manufacturing, and considerably more difficult to achieve.

Executive Summary

In Part 1 of this series, we explored the challenges faced by life science manufacturers around data visibility.

In our follow-up deep dive into real-time visibility, we’ll consider the top needs faced by three major players in pharma manufacturing: Quality Assurance, Supervisors, and Operators.

We will then explore visibility solutions that can address and resolve those needs.

Jump to…

The Need for Data Visibility

Knowledge is power: Power is data

Real time visibility provides a means to access the latest, greatest data. In the pharmaceutical manufacturing space, this means batch data, status updates, material and equipment usage, and more. 

Instant visibility pulls out in real time what’s happening in the moment, so that potential exceptions can be addressed before they escalate. This enables proactive decision making when it’s needed most.

In pharmaceutical manufacturing, there are massive amounts of data. That volume contributes to the potential for delays and errors when data collection processes are outdated.

As Almac’s Matthew Lowrie notes, “One of the biggest issues clients face is not fully taking into account the flow of data in their systems, the various integrations and data exchanges that occur between them, and which are considered source data.”

“Too often there is a disconnect between the siloed teams who aren’t fully aware or consulted on the requirements for the various systems. This leads to large reconciliation efforts at the end of the trial and questions around why the data is being updated sometimes years after its initial entry.”

Matthew Lowrie, Quality Assurance Manager, Almac

Automatic data capture allows data to be digitally logged and shared, so there’s no need to manually record or transcribe it. It’s already there, ready to be sent in just the click of a button.

Real-Time Visibility for Quality Assurance Teams

Quality plays an essential role; visibility makes it possible

Need

Built-in access to instantaneous quality assurance

Solution

  1. Optimize product quality in real time by providing immediate review and resolution of exceptions, instead of waiting months and following a complex and lengthy paper trail.
  2. Minimize non-conformances and ensure higher quality by preventing step completion when values deviate from defined ranges, and automatically calculating formulas.

When verifying the safety and purity of drug batches, quality plays an essential role. But due to the delays and difficulties involved in manual data transfer, they’re often left in the dark until the end of a lifecycle.

Quality control is not just responsible for the release of the batch — they’re often responsible for the release of rooms, materials, and equipment. QA is responsible for all the different stage gates. And that’s why real-time data is so important.

“With better visibility into your supply chain, you will have an unbroken chain of data that not only means just information, but also leads you to meaningful analysis of the situation and better, as well as timely decisions.”

Ivan Diaz, Vice President of Global Customer Success, Roambee

Cloud-based data systems give Quality Assurance teams a way to review data on an ongoing basis in parallel with manufacturing, not all at the end. 

As Apprentice Application Specialist Laura Jacoby explains, “With real-time data, you have visibility from the moment you start your manufacturing process until the end, instead of getting everything afterwards and having to review it all at once.”

Real-Time Visibility for Supervisors

Need

A holistic view into production and facility resources

Solution

  1. Accurately capture your resource management structure. With customizable hierarchies, profiles, and statuses, create a definition for materials, equipment, and locations that reflects how your facility manages resources.
  2. Manage material inventory in real time. Oversee the lifecycle of materials and work-in-progress (WIP) inventory with weigh and dispense and inventory management capabilities that update in real-time, as inventory is used inside and outside of batches.
  3. Manage your operations from a single dashboard. With one-page dashboards for batch and procedure execution, you will always have visibility into real-time execution across all your teams and sites.

Supervision is a key role in pharmaceutical manufacturing. Supervisors ensure that all the complex manufacturing procedures get performed correctly, safely, and on time.

Supervisors need a bird’s-eye view of everything that’s happening. With manual data processing, the efforts needed to achieve this become laborious and time-consuming. This contributes significantly to disruptions in supply chain response and agility.

“Up-front planning for management and oversight of trial data is key. When multiple systems are in play, which is most often the case, planning for how data changes will flow between systems must be accounted for. Oftentimes, the initial data entry is the primary focus.”

Cheryl Kole, Head of Solutions Strategy, Almac

With cloud-based systems, supervisors can have instantaneous feedback into all the resource management, material inventory, and operational execution data at all times.

This way, they can have all the information they need to make the right decisions at the right time.

They also have the flexibility to set parameters in advance, so they can streamline the events that need to happen for varying levels of non-conformances and exceptions.

Real-Time Visibility for Operators

Need

A way to author and execute as a team with shared access to data and progress

Solution

  1. Collaboratively author recipes. Multiple users can author recipes together in real time with live group-editing collaboration tools.
  2. Collaboratively execute recipes. Assign steps to different users and observe real-time completion so recipes can be executed in parallel.

For technicians and operators on the floor, data is plentiful but hard to parse. Knowing where their coworkers left off and what they accomplished in their last shift is hugely valuable. 

In other words, it’s not only about gaining access to information. It’s the need to have an intuitive, navigable way to find and share that information.

Currently, many operators use paper logbooks to track and communicate these updates. But the cloud is picking up speed as a scalable solution for growth-minded manufacturers. 

“Having real-time data at their fingertips empowers manufacturers to automate routine tasks, so they can focus their time and energy on optimizing and analyzing their data.”

Laura Jacoby, Application Specialist, Apprentice

Cloud-based MES gives technicians and operators a way to effortlessly log and share data updates with their colleagues and supervisors. This is a huge boon with the massive amounts of data needed at the preclinical and clinical stages of drug manufacturing.

With cloud-based MES, it’s not just the documentation that’s easier. It’s how simply operators can find and share it.

Real-Time Visibility: Why It’s Necessary

In short, real-time data visibility gives pharma teams time back in their day. And what’s more valuable than time?

No more unnecessary shifts. No more taking data home with you at the end of the day. No more late night working (or hey, at least less of it).

Real-time visibility gives you a way to access the exact data you need to review, exactly when you need it.

“It takes countless binders to make a batch. Shelves filled with binders. With real-time data, you can automate the manual tasks that are draining your time and resources.”

Laura Jacoby, Application Specialist, Apprentice

Instead of working in facilities all day, and reviewing data all night, teams can make the most efficient use of their time by automating data capture.

During batch execution, real-time visibility into production status and quality data ensures quality issues can be addressed and the release timeline accurately managed, whether production is in-house or handled by a contracted partner.

Real-time visibility keeps the supply chain running smoothly, giving all parties a way to analyze crucial data updates in real time.

Over 43% of pharma supply chain companies report a lack of supply chain agility.

Source: IDC and TraceLink’s Supply Chain Survey, 2020 (n=532)

So what’s the bottom line? Real-time visibility can help you:

  • Reduce batch data entry errors
  • Free up time and resources
  • Save money from costly delays
  • Fix potential errors before they start
  • Make informed decisions on your supply chain

It gives teams the agility to review and take action on critical parameter values, critical quality attributes, process issues, and non-conformances to improve quality and reduce product release times. Not retrospectively, but in the moment.

Apprentice for ALCOA+ Data Solutions

At Apprentice, we’re proud to be a cloud-first software provider. This means that cloud strategy is built into the core of what we do, not retrofitted to outdated on-premise solutions.

To learn more about the cloud, you can read our top 10 cloud SaaS questions, answered.

We’re also keenly aware of the challenges faced by latencies in the life science industry. Our CEO Angelo Stracquatanio built the company specifically to address these challenges. And our team is dedicated to creating solutions that meet the strict demands and regulatory requirements needed in the pharma space. 

That means data that follows the ALCOA+ principles. To start, that means data that’s:

Attributable

Legible

Contemporaneous

Original

Accurate

The + symbol at the end of ALCOA+ covers a few more key principles: Complete, Consistent, Enduring, and Available. 

All together, these principles represent the FDA’s core standards for data integrity.

In the words of Laura Jacoby, “Pharma manufacturing is not the place for shortcuts.”

ALCOA+ may not be the easiest option, but it’s certainly the safest. And that’s why we’re committed to finding ways to make data integrity possible and feasible for all life science manufacturers at scale.

We help you automate routine tasks, so you can free up time and resources for the expertise that can’t be automated. Get to know us.

Discover Tempo: Instantaneous Data Visibility

Here at Apprentice, we believe in doing what we can to make your lives easier. That’s why we built Tempo: our one-stop solution for real-time visibility across your sites, products and resources. 

Through Tempo, we harness the cloud to automate your data capture and transfer. 

With Tempo, your global production teams can operate in real time from a single shared application that combines manufacturing and lab execution functionality with built-in collaboration. 

Whether it’s batch records, equipment or inventory usage, laboratory execution or real-time collaboration tools that you need, we’ve got you covered. Discover Tempo.

Talk to Our Experts in Real Time

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Want to discuss your real-time visibility needs in real time? We’ve got a team of data processing experts who would be happy to talk with you! Get in touch.

References

  1. IDC: These 3 Capabilities Will Help You Increase Supply Chain Agility. (2020, November 13). Tracelink. https://www.tracelink.com/agile-supply-chain/insights/idc-these-3-capabilities-will-help-you-increase-supply-chain-agility
  2. Parker, B. (2020, August 21). Enabling Data Visibility in Contract Manufacturing Networks. Skyland Analytics. https://skylandanalytics.net/articles-and-editorials/whitepapers/creating-cdmo-supply-chain-data-visibility/
  3. Pavlović, A. (2019, July 11). How to meet all 9 ALCOA principles. Ideagen. https://www.ideagen.com/thought-leadership/blog/how-to-meet-all-9-alcoa-principles-with-our-document-module
  4. Spinner, J. (2022, March 1). Data history visibility keeps clinical studies on track: Almac. Outsourcing Pharma. https://www.outsourcing-pharma.com/Article/2022/03/01/Data-history-visibility-keeps-clinical-studies-on-track-Almac
  5. Teradata Analyst. (2021). On-Premises vs Cloud: Pros and Cons. Teradata. https://www.teradata.com/Trends/Cloud/On-Premises-vs-Cloud
  6. West, C., & de Muynck, B. (2021, July 26). How to Assess the Benefits and Return on Investment of a Real-Time Transportation Visibility Platform. Gartner. https://www.gartner.com/en/documents/4004052/how-to-assess-the-benefits-and-return-on-investment-of-a-real-time-transportation-visibility-platform
  7. ZS Analyst. (2021, September 3). The future of data in pharma: Data privacy, data ownership and going beyond the pill. ZS Firm. https://www.zs.com/insights/the-future-of-data-in-pharma-data-privacy-data-ownership-and-going-beyond-the-pill