* Customer: Align Technology, Inc.
* Industry: Medical Device (Class II)
* Challenge: Implement a robust electronic document management system to support growth, as well as meet and maintain regulatory compliance.
* Solution: Arena
* Results: Align cut ongoing compliance cost by more than $250,000 annually. Change implementation used to take 22 days, but now takes only three to five days.
Align Technology, Inc. (NASDAQ: ALGN) is a medical device company engaged in the design, manufacture and marketing of Invisalign, the world's leading invisible orthodontic product. Invisalign is a series of clear, removable aligners that both orthodontists and general dentists use to straighten their patients' teeth. With more than twenty million unique aligners made to date, Align is one of the largest manufacturers of mass customized products in the world.
With operations in both Mexico and Costa Rica, Align's entire production process is documented in approximately 1000 highly detailed operating procedures and company SOPS, which must be accessed by more than 500 technical and production staff members. Additionally, another 400 employees from Align's development teams in Russia, and its corporate personnel worldwide, access the production information 24/7.
Challenge
In mid-2002, Align employed about 300 people. But with plans for major expansion, the company's management team identified electronic document management as a vital component for continued growth. The company then hired Meredith Yost, a 25-year industry veteran, to take charge of the document management initiative.
"Our executive team had the foresight to know that a scalable document control function is essential for growing the business," said Len Hedge, Vice President of Operations for Align in Santa Clara, Calif. "If you see implementation times for documentation changes increase, you may have already painted yourself into a corner, as Food and Drug Administration (FDA) regulations do not allow for shortcuts. We knew that investing in document management would be critical."
One of Align's business goals was to reduce the time needed to process change orders. Prior to implementing Arena, Align had managed change orders through manual, paper-based processes, which created a significant backlog and resulted in cycle times of sometimes up to 22 days. Additionally, management wanted to shift the change approval responsibility to the people involved in daily operations rather than relying as heavily on senior executives. Only then could the company increase internal efficiency and position itself for long-term growth.
Align managed production procedures and documentation in folders on a shared, read-only file server where only document control personnel could make modifications. Because all changes required manual updating on both the production folders and the "down-rev folders," personnel were required to duplicate work efforts to ensure referential integrity between documents.
Employees found it difficult to find the proper revisions of specific documents. Even with the "file search" capability, employees would turn up many versions of a documentonly one of which was the effective revision. The wasted time, when multiplied by the number of employees needed to find the effective document, and the number of times per day employees needed to access it, resulted in a high hidden cost.
The Invisalign system is designated as a Class II medical device, meaning that Align is required to follow the FDA's regulations on manufacturing and reporting. Align also distributes its product to Europe, requiring the company to adhere to ISO13485:2003 regulations. With the complexities associated with the FDA's Good Manufacturing Practice (GMP) and the European ISO standard, Align needed two full-time staff members in document control to manage compliance. Given the company's forecasted growth, executives expected Align would need a total of four full-time employees within two years.
It was abundantly clear to Yost that Align needed to migrate from its manual, paper-based documentation and change management processes to a comprehensive and automated document management system.
* Industry: Medical Device (Class II)
* Challenge: Implement a robust electronic document management system to support growth, as well as meet and maintain regulatory compliance.
* Solution: Arena
* Results: Align cut ongoing compliance cost by more than $250,000 annually. Change implementation used to take 22 days, but now takes only three to five days.
Align Technology, Inc. (NASDAQ: ALGN) is a medical device company engaged in the design, manufacture and marketing of Invisalign, the world's leading invisible orthodontic product. Invisalign is a series of clear, removable aligners that both orthodontists and general dentists use to straighten their patients' teeth. With more than twenty million unique aligners made to date, Align is one of the largest manufacturers of mass customized products in the world.
With operations in both Mexico and Costa Rica, Align's entire production process is documented in approximately 1000 highly detailed operating procedures and company SOPS, which must be accessed by more than 500 technical and production staff members. Additionally, another 400 employees from Align's development teams in Russia, and its corporate personnel worldwide, access the production information 24/7.
Challenge
In mid-2002, Align employed about 300 people. But with plans for major expansion, the company's management team identified electronic document management as a vital component for continued growth. The company then hired Meredith Yost, a 25-year industry veteran, to take charge of the document management initiative.
"Our executive team had the foresight to know that a scalable document control function is essential for growing the business," said Len Hedge, Vice President of Operations for Align in Santa Clara, Calif. "If you see implementation times for documentation changes increase, you may have already painted yourself into a corner, as Food and Drug Administration (FDA) regulations do not allow for shortcuts. We knew that investing in document management would be critical."
One of Align's business goals was to reduce the time needed to process change orders. Prior to implementing Arena, Align had managed change orders through manual, paper-based processes, which created a significant backlog and resulted in cycle times of sometimes up to 22 days. Additionally, management wanted to shift the change approval responsibility to the people involved in daily operations rather than relying as heavily on senior executives. Only then could the company increase internal efficiency and position itself for long-term growth.
Align managed production procedures and documentation in folders on a shared, read-only file server where only document control personnel could make modifications. Because all changes required manual updating on both the production folders and the "down-rev folders," personnel were required to duplicate work efforts to ensure referential integrity between documents.
Employees found it difficult to find the proper revisions of specific documents. Even with the "file search" capability, employees would turn up many versions of a documentonly one of which was the effective revision. The wasted time, when multiplied by the number of employees needed to find the effective document, and the number of times per day employees needed to access it, resulted in a high hidden cost.
The Invisalign system is designated as a Class II medical device, meaning that Align is required to follow the FDA's regulations on manufacturing and reporting. Align also distributes its product to Europe, requiring the company to adhere to ISO13485:2003 regulations. With the complexities associated with the FDA's Good Manufacturing Practice (GMP) and the European ISO standard, Align needed two full-time staff members in document control to manage compliance. Given the company's forecasted growth, executives expected Align would need a total of four full-time employees within two years.
It was abundantly clear to Yost that Align needed to migrate from its manual, paper-based documentation and change management processes to a comprehensive and automated document management system.
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