{"id":81321,"date":"2024-12-19T18:58:51","date_gmt":"2024-12-19T17:58:51","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=customer-stories&p=81321"},"modified":"2026-03-27T21:47:03","modified_gmt":"2026-03-27T20:47:03","slug":"forge-boosts-efficiency-during-external-collaboration","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/forge-boosts-efficiency-during-external-collaboration\/","title":{"rendered":"Forge Biologics"},"content":{"rendered":"

\nDespite impacting the lives of an estimated 30 million people in the U.S., 95% of rare diseases have no FDA-approved treatments1<\/sup>. At its 200,000-square-foot manufacturing facility (\u201cThe Hearth\u201d) in Columbus, Ohio, Forge Biologics’ mission is to increase access to safe and effective treatments for patients. Founded in 2020, the contract development manufacturing organization (CDMO) is an AAV gene therapy company focused largely on rare diseases. The faster its clients get their products into clinical trials, the sooner patients benefit from access to treatment.\n<\/p>\n

\nServing clients worldwide, and addressing both rare and increasingly prevalent diseases, is at the core of Forge\u2019s business model and its commitment to meeting evolving industry needs. To reduce turnaround times, it needed to improve external collaboration during batch manufacturing, disposition, and client acceptance. If clients could start reviewing dispositions once manufacturing and quality reviews were complete, they could provide real-time feedback and approve product-impacting quality events. To achieve its goals, Forge implemented ³Ô¹Ï±¬ÁÏ Quality.\n<\/p>\n

Turning the page on document change control<\/h2>\n

\nAmong those contributing to Forge\u2019s growth story from the beginning was Director of Quality Management, Ryan Heil. Heil\u2019s team realized improving external collaboration would provide more visibility and agency over product-impacting deviations, change controls, and complaints.\n<\/p>\n

\nWhile Forge\u2019s customer base ranges from private biotechs to listed companies, NGOs, and foundations, all organizations focused on rare diseases know that time is of the essence: \u201cWe wanted a modern, digital-first solution and to allow our clients access to the quality system so they could accelerate their timelines from development to GMP manufacturing,” he says.\n<\/p>\n

\nAfter mapping out the company\u2019s external collaboration processes and deliverables, it became clear that clients become part of Forge\u2019s workflows when specifying document requirements and reviewing and approving batch records and test methods. These activities added significant time because they took place in shared drives, or by email, using e-signature tools, and could involve searching for documents in legacy folder structures. It was difficult to maintain version control unless one person collated all the document changes.\n<\/p>\n

\nCollaborating in a unified quality management system eliminates side conversations and restores version control. By changing how it worked, Forge realized it could reduce the turnaround time for reviews and approvals to deliver batch records sooner to clients. The internal project management teams could keep track of the status of batch records and obtain client signatures. Clients could track progress with investigations, review timelines, and start reviews before getting the full disposition packet.\n<\/p>\n

Seamless collaboration leads to faster batch release<\/h2>\n

\nComprised of only a few dozen people when it started, digital communication was a key factor in Forge\u2019s early success. As the company grew, ensuring easy external collaboration on document changes and quality events became critical.\n<\/p>\n

\nForge implemented three ³Ô¹Ï±¬ÁÏ quality applications using standard workflows and procedures: ³Ô¹Ï±¬ÁÏ QualityDocs, ³Ô¹Ï±¬ÁÏ QMS, and ³Ô¹Ï±¬ÁÏ Training. Knowing that internal and external quality reviewers would need to collaborate on documents, ³Ô¹Ï±¬ÁÏ introduced a multi-document workflow during configuration to break out security settings, notifications, and due dates for different types of reviewers. This addressed a previous driver of delays, where internal collaborators would \u2018check out\u2019 documents blocking clients from working on them. \u201cCollaborative authoring is a strong tool we wanted to leverage and a key selling point for QualityDocs and Training,\u201d Heil explains.\n<\/p>\n

\n\u201cCollaborative authoring is a strong tool we wanted to leverage and a key selling point for QualityDocs and Training.”
\n\u2014 Ryan Heil, Director of Quality Management, Forge Biologics<\/span>\n<\/p><\/blockquote>\n

\nWorking within a connected quality management platform ensures compliance when collaborating externally. Not only has Forge eliminated non-secure communication methods (like email and shared drives), but it\u2019s also much easier to involve clients in change control. For example, if the team comes across a quality event, it can add clients and share information with them for quick and easy review. Clients can then provide their impact assessments of the changes within QMS. \u201cWe\u2019re able to capture clients\u2019 signatures on documents and major quality events that require their oversight and approval,\u201d explains Heil.\n<\/p>\n

\n“Using ³Ô¹Ï±¬ÁÏ Quality as a single source of truth means it\u2019s straightforward to share reviewed and executed batch records with clients. This reduces document review and approval cycle times, improving the client experience.”\n<\/p>\n

\n\u201cUsing a unified quality management platform is helping to reduce turnaround times for faster R&D and manufacturing. Teams of internal and external collaborators are more efficient.”
\n\u2014 Ryan Heil, Director of Quality Management, Forge Biologics<\/span>\n<\/p><\/blockquote>\n

\nForge is now considering adding other solutions, such as batch release, to support client communication further: \u201cThe product development (PD) folks are asking if we can use ³Ô¹Ï±¬ÁÏ for PD documents as well.\u201d\n<\/p>\n

On a faster path to submissions<\/h2>\n

\nUsing a unified quality management platform is helping to reduce turnaround times for faster R&D and manufacturing. Teams of internal and external collaborators are more efficient when executing manufacturing, obtaining procedures to run new processes or equipment, and delivering QC results to disposition products. \u201cThe big benefit of having a unified quality management system that includes documents, training, QMS, and LIMS is that people can go to ³Ô¹Ï±¬ÁÏ as the single source of truth,\u201d says Heil.\n<\/p>\n

\nCustomers have shared positive feedback on their experiences using ³Ô¹Ï±¬ÁÏ Quality. Many were already Vault platform users and only needed limited training to get up and running. Now they can see their tasks, due dates, executed records, analytical method development, and product-specific methods in one place, clients can get their work done immediately.\n<\/p>\n

\nThe connections with Vault Regulatory Publishing also benefit Forge\u2019s internal operations, as it can track the regulatory impact of change controls and accelerate the path to submission. Heil concludes: \u201c³Ô¹Ï±¬ÁÏ is a really powerful tool. By having multiple Vaults, we\u2019re able to identify changes from ³Ô¹Ï±¬ÁÏ Quality into ³Ô¹Ï±¬ÁÏ RIM. This way, we can track updates to any regulatory documentation we may need.\u201d\n<\/p>\n

Data to fast-track treatment<\/h3>\n

\nGiven its quality applications share a common data foundation, Forge benefits from enhanced reporting and metrics. These capabilities help it prioritize quality events, deviations, and change controls, so it can complete its package and deliver materials swiftly to clients.\n<\/p>\n

\n\u201cExternal collaboration is a critical part of any CDMO\u2019s business. At Forge, we’re really leveraging Vault to facilitate that collaboration with our clients, enabling faster turnaround times so patients can access treatments.\u201d
\n\u2014 Ryan Heil, Director of Quality Management, Forge Biologics<\/span>\n<\/p><\/blockquote>\n

\nSoon it anticipates using reporting insights to manage projects more efficiently. Heil adds: \u201cWe\u2019ll use metrics on task completion to identify which document types pose problems. We\u2019ll be able to predict whether client tasks are taking longer or shorter than estimated, so we can plan projects better.\u201d\n<\/p>\n

\nHeil concludes: \u201cExternal collaboration is a critical part of any CDMO\u2019s business. At Forge, we’re really leveraging Vault to facilitate that collaboration with our clients, enabling faster turnaround times so patients can access treatments.\u201d\n<\/p>\n

Hear Ryan’s story in his short video<\/a>.<\/p>\n

Learn why customers benefit from ³Ô¹Ï±¬ÁÏ Quality Cloud<\/a>.\n<\/p>\n

1<\/sup>Rare Diseases Clinical Research Network; Save Rare Treatments Task Force<\/a>
\n<\/sub><\/p>\n","protected":false},"excerpt":{"rendered":"

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