技术
- 应用基础设施与中间件 - 数据交换与集成
- 平台即服务 (PaaS) - 应用开发平台
适用行业
- 电子产品
- 生命科学
适用功能
- 质量保证
用例
- 租赁金融自动化
- 监管合规监控
服务
- 系统集成
关于客户
Pacira 是一家制药公司,致力于推动创新,提供更好的方法来安全有效地管理疼痛。该公司专注于新型产品的开发和商业化,以满足急症护理环境中未满足的重要医疗需求。 Pacira 的监管部门负责确保公司的产品符合所有必要的监管标准和要求。该部门正在寻找一种解决方案,可以简化其宣传材料提交流程,并为协作创作和提交提供安全且符合第 11 部分要求的系统。
挑战
Pacira 是一家制药公司,在简化宣传材料提交流程方面面临着挑战。该公司使用低效的基于纸张和电子邮件的方法,不仅耗时,而且缺乏必要的速度和效率。在大流行期间,由于远程工作人员无法使用高速打印机,这种情况进一步恶化。此外,随着 Pacira 监管部门的发展,他们需要用安全的、符合第 11 部分要求的系统取代 SharePoint,以进行协作创作和提交。该公司还在寻找一种解决方案,可以在同一平台上管理促销提交和其他监管提交。
解决方案
Pacira 四年前实施了 Veeva 的 Vault PromoMats,以帮助医疗、法律和监管团队更快地审查和批准内容。 Vault PromoMats 提供的数字流程比之前基于纸张和电子邮件的方法有了重大改进。该解决方案在 Pacira 向简化、包罗万象的电子 OPDP 提交流程过渡方面发挥了重要作用,比 FDA 的 2021 年 6 月截止日期提前了一整年。为了进一步增强监管流程,Pacira 将 SharePoint 替换为 Vault Submissions、Vault Submissions Publishing 和 Vault Submissions Archive。这些解决方案为协作创作和提交提供了安全且符合第 11 部分要求的系统。 Vault RIM Suite 特别有吸引力,因为它共享 Vault PromoMats 熟悉的界面并使用相同的流程来上传文档。
运营影响
数量效益
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