Terrance Holbrook, Director of Product, MasterControl09.17.19
A small issue can have a big impact in a manufacturing environment. When it comes to producing life-saving medical devices, the stakes are even higher. When manufacturers employ manual, paper-based systems to manage their manufacturing efforts, human errors and poor data integrity have a cascading effect as information advances through the production process. Under these conditions, many manufacturers are discovering they can no longer rely on manual, paper-based systems.
According to a 2019 report from PricewaterhouseCoopers and the Manufacturing Institute—the research arm of the National Association of Manufacturers—73 percent of manufacturers are planning to increase their investment in smart factory technology over the next year.1 The pace of digitization and automation is accelerating in all areas of manufacturing, including the paper-based production-record process, thanks to the emergence of new solutions capable of making the factory floor paperless.
EpiBone, a Brooklyn-based regenerative medicine company, discovered how eliminating paper with digital production records can help ensure data integrity, reduce errors, and increase efficiency.
Why Going Digital Was Important
Regulated by the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), EpiBone is developing living grafts for skeletal reconstruction, essentially taking stem cells and growing them into bone and cartilage, which would then be used to repair damage to bones and joints. The privately held company produces a combination product that is part medical device and part biologic, which must meet the FDA’s stringent 21 CFR 820 requirements. Due to the personalized nature of most of their products, they are often producing a unique product that is a batch of one.
Before implementing a digital solution to manage their production records, EpiBone had a completely paper-based system, which proved inefficient and unwieldy. The system was restrictive in what data types could be captured and review times were long, often taking weeks to sign off on records. To make revisions, it could take a month or longer. To access production information, someone on staff had to hunt down individual documents stored in a filing cabinet.
As a regenerative medicine company with a personalized approach, EpiBone’s production cycle is about five weeks, and with 14 employees, efficiency is critical. The company must review and release production records quickly, completely, and transparently. Recognizing that digital, automated efficiencies could have a dramatic effect on the production of its clinical grade products, EpiBone began qualifying solutions that would improve the way they create and maintain production records.
Selection Criteria
The company determined what capabilities the cloud-based solution had to provide. The digital system had to be compliant and configurable. It had to be secure but with records readily accessible for an auditor to view. It had to incorporate multiple users, workflows, and electronic signatures that follow 21 CFR Part 11 compliance.
EpiBone also wanted forms that follow industry-standard practices, ways to represent steps from initiation to review to conclusion, and to seamlessly connect to documents and ensure timely completion of production records. The company also sought integration options for visibility, data analytics, trending, and reporting. Other applicable capabilities included automated version change management and the ability to launch quality management forms as they occur within the production record.
The company utilized prior experience to evaluate common software concerns and qualify the solutions’ intuitiveness and user-friendliness in the life science industry. Ultimately, EpiBone prioritized a solution that would maintain data integrity from the start and accelerate the review process.
Benefits of Digitized Production Records
Digital production record tools have become critical to EpiBone’s ability to go paperless and drive higher efficiency. According to Pete Raghubans, EpiBone’s quality assurance manager, and Julia Porrino, the company’s quality assurance specialist, digitized production records have added value in three key areas.
Template Building
By digitizing their production record processes, EpiBone has been able to configure the system to its needs. They can easily build and accurately maintain digital master record templates that virtually mimic paper-based records. The company now has the tools to capture many different data types, perform calculations and time capture, and easily attach visuals. For example, some of EpiBone’s processes must be performed for a certain amount of time—e.g., at least 30 minutes or two hours—and the company can automatically record “time in” and “time out” to confirm the processes were performed for the necessary amount of time.
The ability to attach visuals has also helped. When the company relied on a paper-based process, they’d include descriptions of operational processes, but now they can take a photo and attach it to show what it looked like when a step was performed.
The digital output is visible in real-time with the familiar look of paper records. Templates and global elements can now fully automate change management.
Review By Exception
Where the digital solution has helped most is the quality review process, according to Porrino and Raghubans. With a paperless solution, data-entry errors are corrected in real-time, meaning e-signatures are always captured, and dates and times are always correct.
In addition, there is no more page-by-page searching for information, which is now easily accessible to those authorized. The company has gained concurrent review and production, as well as the ability to review and release remotely. They have eliminated interdepartmental review meetings and seen significant time savings.
In fact, the digital production record’s review-by-exception functionality allows the company to close out a production record in 30 minutes, whereas it previously took two weeks to sign off on records, according to Porrino. When making revisions, it could take a month or longer on a paper-based system. Now it takes about a week.
Continuous Validation
The FDA requires electronic systems to be in a constant state of validation, which can demand a substantial investment in time and money. Because EpiBone’s team is just over a dozen users, they don’t have a dedicated IT department. That made it necessary to always have access to a validated system, according to Porrino.
While the digital solution they implemented came with some validation, fit for use at EpiBone also entailed internal validation. As part of its FDA-recommended risk-based approach to validation, the company accepted the software vendor’s full validation performed internally for the cloud release and conducted risk-based validation for its own configuration. For patches, upgrades, and changes to version, the company’s risk-based approach allows it to concentrate on critical business processes, which dramatically eases the traditional validation burden and achieve continuous validation without the resources of a large IT team.
Conclusion
By digitizing the business-critical and inefficient production record process, there is no more missing or illegible data and no incomplete documents, so EpiBone can focus on creating clinical grade products rather than managing paperwork. By improving the efficiency of master record revisions, the company has produced cost savings equivalent to cutting man-hours from one month to one week.
On average, it takes 10 years to get a new product to market. Sometimes, it can take that long just to get clinical trial approval. EpiBone has already outpaced that milestone, having hit it in six years. The company is about to go into a Phase 1/2 clinical trial for mandibular repair.
Reference
Terrance Holbrook is a director of product at MasterControl, where he is responsible for market research, product design, and development of software features and functionality for the company’s innovative Manufacturing Excellence solutions suite. With 25 years of experience in manufacturing and seven years in international medical device product development, Holbrook has honed his expertise in the entire R&D and operations lifecycle, particularly scaleup process control and improvement.
According to a 2019 report from PricewaterhouseCoopers and the Manufacturing Institute—the research arm of the National Association of Manufacturers—73 percent of manufacturers are planning to increase their investment in smart factory technology over the next year.1 The pace of digitization and automation is accelerating in all areas of manufacturing, including the paper-based production-record process, thanks to the emergence of new solutions capable of making the factory floor paperless.
EpiBone, a Brooklyn-based regenerative medicine company, discovered how eliminating paper with digital production records can help ensure data integrity, reduce errors, and increase efficiency.
Why Going Digital Was Important
Regulated by the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), EpiBone is developing living grafts for skeletal reconstruction, essentially taking stem cells and growing them into bone and cartilage, which would then be used to repair damage to bones and joints. The privately held company produces a combination product that is part medical device and part biologic, which must meet the FDA’s stringent 21 CFR 820 requirements. Due to the personalized nature of most of their products, they are often producing a unique product that is a batch of one.
Before implementing a digital solution to manage their production records, EpiBone had a completely paper-based system, which proved inefficient and unwieldy. The system was restrictive in what data types could be captured and review times were long, often taking weeks to sign off on records. To make revisions, it could take a month or longer. To access production information, someone on staff had to hunt down individual documents stored in a filing cabinet.
As a regenerative medicine company with a personalized approach, EpiBone’s production cycle is about five weeks, and with 14 employees, efficiency is critical. The company must review and release production records quickly, completely, and transparently. Recognizing that digital, automated efficiencies could have a dramatic effect on the production of its clinical grade products, EpiBone began qualifying solutions that would improve the way they create and maintain production records.
Selection Criteria
The company determined what capabilities the cloud-based solution had to provide. The digital system had to be compliant and configurable. It had to be secure but with records readily accessible for an auditor to view. It had to incorporate multiple users, workflows, and electronic signatures that follow 21 CFR Part 11 compliance.
EpiBone also wanted forms that follow industry-standard practices, ways to represent steps from initiation to review to conclusion, and to seamlessly connect to documents and ensure timely completion of production records. The company also sought integration options for visibility, data analytics, trending, and reporting. Other applicable capabilities included automated version change management and the ability to launch quality management forms as they occur within the production record.
The company utilized prior experience to evaluate common software concerns and qualify the solutions’ intuitiveness and user-friendliness in the life science industry. Ultimately, EpiBone prioritized a solution that would maintain data integrity from the start and accelerate the review process.
Benefits of Digitized Production Records
Digital production record tools have become critical to EpiBone’s ability to go paperless and drive higher efficiency. According to Pete Raghubans, EpiBone’s quality assurance manager, and Julia Porrino, the company’s quality assurance specialist, digitized production records have added value in three key areas.
Template Building
By digitizing their production record processes, EpiBone has been able to configure the system to its needs. They can easily build and accurately maintain digital master record templates that virtually mimic paper-based records. The company now has the tools to capture many different data types, perform calculations and time capture, and easily attach visuals. For example, some of EpiBone’s processes must be performed for a certain amount of time—e.g., at least 30 minutes or two hours—and the company can automatically record “time in” and “time out” to confirm the processes were performed for the necessary amount of time.
The ability to attach visuals has also helped. When the company relied on a paper-based process, they’d include descriptions of operational processes, but now they can take a photo and attach it to show what it looked like when a step was performed.
The digital output is visible in real-time with the familiar look of paper records. Templates and global elements can now fully automate change management.
Review By Exception
Where the digital solution has helped most is the quality review process, according to Porrino and Raghubans. With a paperless solution, data-entry errors are corrected in real-time, meaning e-signatures are always captured, and dates and times are always correct.
In addition, there is no more page-by-page searching for information, which is now easily accessible to those authorized. The company has gained concurrent review and production, as well as the ability to review and release remotely. They have eliminated interdepartmental review meetings and seen significant time savings.
In fact, the digital production record’s review-by-exception functionality allows the company to close out a production record in 30 minutes, whereas it previously took two weeks to sign off on records, according to Porrino. When making revisions, it could take a month or longer on a paper-based system. Now it takes about a week.
Continuous Validation
The FDA requires electronic systems to be in a constant state of validation, which can demand a substantial investment in time and money. Because EpiBone’s team is just over a dozen users, they don’t have a dedicated IT department. That made it necessary to always have access to a validated system, according to Porrino.
While the digital solution they implemented came with some validation, fit for use at EpiBone also entailed internal validation. As part of its FDA-recommended risk-based approach to validation, the company accepted the software vendor’s full validation performed internally for the cloud release and conducted risk-based validation for its own configuration. For patches, upgrades, and changes to version, the company’s risk-based approach allows it to concentrate on critical business processes, which dramatically eases the traditional validation burden and achieve continuous validation without the resources of a large IT team.
Conclusion
By digitizing the business-critical and inefficient production record process, there is no more missing or illegible data and no incomplete documents, so EpiBone can focus on creating clinical grade products rather than managing paperwork. By improving the efficiency of master record revisions, the company has produced cost savings equivalent to cutting man-hours from one month to one week.
On average, it takes 10 years to get a new product to market. Sometimes, it can take that long just to get clinical trial approval. EpiBone has already outpaced that milestone, having hit it in six years. The company is about to go into a Phase 1/2 clinical trial for mandibular repair.
Reference
Terrance Holbrook is a director of product at MasterControl, where he is responsible for market research, product design, and development of software features and functionality for the company’s innovative Manufacturing Excellence solutions suite. With 25 years of experience in manufacturing and seven years in international medical device product development, Holbrook has honed his expertise in the entire R&D and operations lifecycle, particularly scaleup process control and improvement.
