Addressing the Challenges of ATMP Manufacturing

Apperture understands your unique challenges—regardless of where you are in the product/production lifecycle. From establishing a technology infrastructure and information security, through the management of equipment, documents, and materials, to facilitating the use of data for analytics and visualization, we have the expertise and knowledge to support a variety of solutions to meet your needs.

Automation & Scalability

By utilizing automation to support production scale-up, our solutions help ATMP manufacturers meet these challenges to ensure consistent quality and performance.

Explore our Electronic Batch Records and Electronic Logbook Solutions

Data Integrity & Compliance

Current quality control methods may not be robust enough to detect subtle variations in ATMP products. Our solutions ensure the process is accurate, consistent, and reliable—facilitating data integrity and regulatory compliance throughout the product lifecycle.

Explore our GMP-Compliant ETL and QMS/MES Integration Solutions

Data Management & Digital Infrastructure

Capturing real-time data from Life Sciences processes is critical for optimization and compliance. Our solutions help you capture, contextualize, and analyze manufacturing data to ensure product quality, regulatory compliance, and operational efficiency.

Explore out Digital Dashboards, Data Warehousing, and Data Analytics Solutions

We Have the Right Solutions to Achieve Your Goals

Our clients can trust that we are the right organization to partner with—now and for the long term. We not only have the expertise to engineer and deploy these solutions but also the industry-specific knowledge and experience to ensure they are architected in a reliable, scalable, and forward-looking manner.

Customer Use Case: Audit Trail Data From 100 Devices Across 8 Manufacturing Areas

Data integrity plays a critical role for any life science manufacturer, so imagine having to collect and discern audit data from almost 100 devices across eight manufacturing areas. It’s nearly impossible to generate audit trails on all the various devices with different HMIs and islands of information everywhere.

Solve Your Compliance Vulnerability Issues With Informetric Systems’ InfoBatch® InfoETL
Apperture Solutions has partnered with Informetric Systems to provide an advanced technology solution that can:

• Accommodate disparate and, frequently, siloed data
• Remove the entire human data collection and analysis headache
• Automate and streamline the entire process
• Eliminate data integrity vulnerabilities
• Include reporting and routing for electronic approval
• Be GMP-compliant

Save Time & Money

by eliminating human data collection

Eliminate Audit Trail Vulnerabilities

with a secure, automated solution for collection and reporting

Gain GMP-Compliance Confidence

with access to comprehensive, reliable audit trails

Learn More About the Data Integrity Benefits of InfoETL

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Address Your Cybersecurity Challenges and Concerns

Accomplish a culture of cybersecurity through a combination of technologies, strategies, and processes. Our assessment is an integral part of the continuous improvement process that comprises a sound cybersecurity program. We start by identifying risks and areas for improvement. Then we use network monitoring tools to identify real vulnerabilities, provide tactical recommendations, and create a roadmap for remediation.

Our advanced cybersecurity assessment measures practices and procedures against the industry standard, NIST SP800-82, to identify, protect/detect, respond, recover, and govern your organization’s cybersecurity risk. As part of our advanced assessment, we’ll also create an inventory of your OT assets.

Realize the Benefits of Our Expertise

• Protection Throughout Your Cybersecurity Journey
• Network Infrastructure Setup, Configuration, & Maintenance
• Application Integration, Regardless of Platform
• Reliability for Your Network and Your Software Applications

Strengthen Your Physical & Digital Assets and Practices.
Schedule Your Cybersecurity Assessment Today.

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Meeting the challenges of improving unit operations requires the use of OT data that spans multiple departments. Apperture’s Data Workshop is an ideal way to get to the most impactful use cases, quickly. We start by getting the right people in the room, diving into pain points, finding symptoms of variability, and then discussing how your data can drive analytics use cases. Armed with a sound plan, our team leverages a self-service analytics platform called Seeq. The Seeq platform is designed to work with your tribal knowledge of the process and leverages the power of connecting disparate data sources.

Data Analytics Workshop Addresses Big Challenges

Our data workshop is designed to address big, overall objectives, including:

• Production yield
• Production capacity
• Production schedule adherence
• Unplanned downtime
• Equipment performance
• Overall Equipment Effectiveness

Apperture ensures success throughout your data analytics journey by developing a strong relationship with your team. Using our Data Workshop format, we learn where we can complement your talent and drive the most impactful goals.

Start your Data Analytics journey more quickly using Seeq and the data analytics experts at Apperture Solutions.
We can drastically cut down the amount of time spent fixing time-series data so you can spend more time coming up with brilliant ideas of solving problems faster.

Elevate Operator Performance & Improve Overall Effectiveness

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Contact Us

Apperture Solutions is thrilled to be attending the upcoming ISPE-CaSA Tech Show on Wednesday, February 28th at the Raleigh Convention Center. We invite you to stop by booth #617 to engage with our Life Sciences consultants about the benefits of integrating silos of data across your organization and transforming that data into actionable information. Our goal is to build bridges across the network to get the right information to the right people and transform your business towards greater efficiency, productivity, and success!

Visit us at booth #617 to learn more about our capabilities and solutions.

Cutting-Edge Data Analytics

Discover how our advanced data analytics tools can unlock hidden insights within your operational data. Our consultants will demonstrate how our solutions empower you to make data-driven decisions that drive efficiency and productivity.

Batch Quality Prediction Example: Delayed lab results make it difficult to optimize input of the process to control the batch yield. By creating an on-line model for yield based upon concentration, volume, and temperature, in near real-time, customers have realized millions in cost savings through rapid identification and root cause analyses of abnormal batches.

Streamlined Operations Management

Learn about our comprehensive operations management solutions designed to optimize your processes from end to end. From inventory management to supply chain optimization, our experts will showcase how we can streamline your operations for maximum performance.

Digital Work Instructions: As production processes become more complex and experienced, plant operators retire and customers struggle to train new operators. Our process experts can define efficient work processes and convert them into digital instructions to guide new operators through their process workflow, using computer vision and dynamic interfaces to alert operators if tasks are performed incorrectly and guide them to do the job right the first time.

WE LOOK FORWARD TO SEEING YOU THERE!

Alarm Management: Critical for Safety and Efficiency

In the era of pneumatic controls, alarms were few and costly. Today, alarms are essentially ‘free’ with an unintended consequence of overuse. This can hinder an operator’s ability to respond to abnormal conditions effectively. Operators often mute speakers to deal with constant interruptions, important alerts go unnoticed, and potential disasters become a looming threat.

With technology advancing and systems growing increasingly complex, effective alarm management is imperative for safety, efficiency, and maintaining order in the digital world.

Alarm Philosophy serves as the cornerstone of the ISA 18.2 Standard. It calls for the creation and upkeep of a guiding document that meticulously outlines the purpose, objectives, roles, responsibilities, and overall strategy concerning alarms. This document acts as the North Star, providing clarity and direction. The Alarm Philosophy establishes a system for prioritizing alarms and includes guidelines for commissioning alarms to ensure seamless integration into the existing system. It also covers training requirements for personnel handling alarms, ensuring proficiency and safety.

Let Apperture be your partner at every stage of your alarm management journey.

What Would Answering All of Your If’s Look Like?

It may be time to take an honest inventory of your organization’s skills, technology capabilities, and operational certainty. Our Managed Services professionals can be an extension of your team—focused on improving operations and lowering costs by minimizing process downtime and risk. That’s why we focus on your objectives, your timetable, your ability to do the work and get trained, and your organization’s appetite for change.

Technology Does Not Stand Still, Nor Should We…Or You

We speak your language—regardless of your process or platform—and we understand your challenges. We listen, ask the right questions, then apply best in class solutions to meet your challenges, based on our team of hands-on, experienced engineers and solutions consultants.

LEARN MORE ABOUT OUR MANAGED SERVICES PRACTICE

Get to Know Our Practice Leader: Boyd Despard

 “I get the most satisfaction from customer enablement—understanding my customers, interpreting their needs, and applying advanced technologies for their benefit. I appreciate the opportunity to explain the amazing tools they have today and how best to leverage them to gain even more value in the near term.” Learn more about Boyd.

by Steve Murray, MES Practice Leader

“As one of our MES Practice Leaders, I spend my days deeply embedded in my specialty, but I’m also aware that while many of our customers are familiar with the terminology, they do not necessarily know where to start to solve their manufacturing challenges. I hope to pique your interest by addressing some of the most commonly asked questions about MES…in a brief, easy-to-understand manner.”

What Value Can an MES Bring to Any (and Every) Manufacturing Organization?

Manufacturing Execution Systems (MES) provide governance of the manual activities that are part of a process manufacturing facility. While automation is certainly a part of most process industries, many manufactured products are produced with steps or tasks performed by humans, as well. There are a number of reasons for this: sites that make many products, making it difficult to automate; products that require ‘in-process’ verifications; and products with variable inputs. This is true for most industries—from pharmaceuticals to battery production to yogurt. Wherever steps are performed without automation, it’s the job of someone in a quality-focused role to question all that can possibly go wrong. Did they use the right materials? Did we establish the required accountability for the production steps? Were the materials in good condition (spoiled milk is still milk)?

Ultimately, the manufacturer has to prove that they produce something consistently—so the customer/consumer has less need to test it and is more confident when they buy it. Quality issues can impact price, involve health or safety questions, and in general, impact the business. The integrity of the manufacturing data is critical—and MES drives that integrity. MES systems can also help lay the ‘data foundation’ for a manufacturing dashboard to help discover and address other manufacturing deficiencies, such as excess hold times.

Who Uses MES Systems?

Many industries use MES systems—they can be either discrete or process manufacturers. The requirements of the MES system are different for each and are often served by different vendors. Discrete manufacturing can be thought of as something like an assembly process. For example, a car needs to be assembled with all of the correct parts (SUV fenders do NOT go on a sedan), all of the parts of a particular model need to be assembled the correct way, and the result is a finite number of sellable units.

Process manufacturing is something that cannot be taken apart or sold in different quantities. Whether you are manufacturing food, paint, or pharmaceuticals, the materials/ingredients have to be mixed, reacted, heated/cooled, and ‘processed’ according to a very specific recipe, with a list of input ingredients. Within process manufacturing, MES systems are most common in processes that make ‘batches’ of product and where there are more manual steps. The need for certainty of the repeatability aspect makes it almost a requirement in pharmaceuticals and biotech, but there is growing demand in the chemical and food industries, as well.

All of this information is integrated with company business systems to support those in supply chain, finance, and quality—who drive orders into the MES and get data back—helping them understand the amount of material in production, produced, and collected as scrap material, for instance.