Despite being a high-tech industry that produces cutting-edge innovations, life sciences has historically been paper-based. Additionally, the industry has always been highly regulated; life sciences companies are mandated to ensure that the proper forms are filled out, signatures are obtained, records are properly archived, and highly complex compliance requirements are adhered to. Not surprisingly, these complex regulatory requirements, combined with a reliance on paper records and manual processes, impaired visibility and efficiency — which in turn stymied innovation.
Recognizing this conundrum, the FDA published 21 CFR Part 11 in 1997. The regulations, which apply to all FDA program areas, outline a set of requirements for utilizing electronic records and signatures in lieu of paper records and handwritten signatures. In the wake of 21 CFR Part 11, software companies quickly brought enterprise content management (ECM) solutions to market that offered FDA-friendly features, such as system validation, audit trails and, of course, electronic signatures and documentation.
Many legacy ECM platforms are still in use today, but a modern, cloud-based quality management system (QSM) is a much better option. AODocs for Life Sciences is a QSM that helps companies address their compliance needs and intelligently move towards more efficient execution, more effective engagement, and faster delivery of innovative products. As an AODocs partner, SADA helps our life sciences customers integrate AODocs with G Suite to optimize their investment by ensuring maximum compliance with industry regulations.
Here are 5 reasons why our clients are retiring their legacy ECM solutions and switching to AODocs for Life Sciences QMS:
- Developed in the Cloud, for the Cloud
Legacy ECM solutions were first developed when organizations ran software on-prem. As cloud computing quickly grew in popularity, developers attempted to shoehorn in cloud-based features, but their legacy footprint looms large. Often, these systems offer little more than electronic versions of complex, inefficient paper processes.
AODocs was designed in the cloud, for the cloud, and has no legacy footprint. Instead of digitizing cumbersome paper processes, AODocs replaces them with automated tools such as native version control and collaborative editing and approval.
- Document Management & Office Files Collaboration
Legacy ECM systems may support only Microsoft Office or PDF documents, which presents a serious stumbling block for organizations that have migrated to G Suite. AODocs seamlessly integrates with G Suite while also supporting Word, Excel, PowerPoint, and any other format you can store in Google Drive.
- Meets Compliance Requirements Out of the Box
AODocs was built on top of G Suite and enables compliance with 21 CFR Part 11, GxP, and other regulatory requirements, without the need for extensive customization. Not only is AODocs the only document management and business process platform that is fully integrated with G Suite, it is used by Google and recommended for G Suite.
- Automated GxP Validation
Software validation is the bane of every company that uses a legacy ECM system; it is a cumbersome process that consumes days, possibly even weeks. AODocs for Life Sciences eliminates this burden with its continuous validation platform, powered by xLM, which delivers a GxP Qualification Suite with every patch/release at the platform and library levels. You get stable, controlled releases, documentation to show that the system is operating according to its intended use, and a human-readable audit log to track changes and user activity.
- Ease of Use
AODocs was designed with end-users in mind. It’s easy for your administrators to set up, and it’s even easier for your teams to use, with a simple, intuitive user interface, customized workflows, and personalized approval of new policies. Content creation is speedy, edits are collaborative, and versioning is a snap, allowing your teams to focus on innovation instead of getting bogged down in documentation processes.
One study found that 60% of life sciences companies feel that a scalable cloud environment is “most important,” but only 20% report having a “mature digital enterprise.” 1 AODocs for Life Sciences lets organizations utilize the automation and collaborative features of the cloud to control their documents, scale their mission-critical processes, meet compliance requirements, save time and money, and drive innovation by enhancing the user experience.
As a trusted Google Cloud Premier Partner, SADA is dedicated to making sure customers using Google Cloud products understand and leverage the full capabilities of the platform. Learn how we can help you integrate AODocs with G Suite to optimize your investment by ensuring maximum compliance with industry regulations.