ENSUR SaaS (Software as a Service)

GxP Compliant Cloud Services for Highly Regulated Industries

Highly regulated companies are often restricted by legacy systems and technologies that make data transparency difficult and inefficient. Additionally, the burden of regulatory compliance requires increased IT resources to update your applications and systems accordingly. As these expenses increase, it becomes harder to create the business efficiency and agility necessary to increase your competitiveness and tap into potential revenue.

DocXellent, in partnership with AWS, provides a fully compliant GxP and FDA 21 CFR Part 11 cloud solution that ensures data integrity in an audit-ready environment. The ENSUR SaaS (Software as a Service) (ENSUR SaaS) is the collection of people, competencies, and process controls provided by DocXellent that enables you to achieve well-architected, reliable, secure, durable, and compliant Cloud frameworks that promote business operations and growth.

Save Time, Lower Risks, and Increase Agility

The ENSUR SaaS enables you to streamline your workflows while exceeding regulatory requirements, giving you more time to focus on getting products to market faster. Move your on-site applications and data to a platform that is accessible, highly available, performant, and scalable.

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Key Benefits of Moving Your Validated Systems into the ENSUR SaaS

  • Reduced Validation Overhead – DocXellent performs all validation activities and provides all artifacts needed to prove compliance for your dedicated single-tenant Cloud platform and all software deployed within it.
  • Reduced Risks – DocXellent is responsible for protecting against loss of data or productivity and managed backup and recovery tools and testing as well as executing all needed change management for your platform.
  • Improved Security – Our industry-leading security program uses proven security frameworks with multiple layers of defenses, protections monitors, and alerts
  • Improved Collaboration & Accessibility – With your applications in the ENSUR SaaS, employees, suppliers, and contractors can safely access them with their credentials through the web on any device, anywhere without the need for a VPN.
  • Reduced IT Overhead – Using your own resources can become costly with the ongoing operation and maintenance required of a compliant cloud environment. Let our experts do the heavy lifting for you.
  • Scalability – The cloud can grow to virtually unlimited size and DocXellent provides the added storage.

Break Free from Validation Pain and Step into the World of Hassle-free Regulatory Compliance

As the first AWS partner to achieve and receive compliance statements from AWS for every line of the CFR Part 11 predicate rule, DocXellent is uniquely qualified to provide FDA 21 CFR Part 11 compliant cloud services. Our Quality Program assures that all regulatory concerns are built into every step of the planning, delivery, and maintenance phases of the solution to guarantee regulatory compliance. Your team will no longer need to worry about validation efforts, as DocXellent is responsible for all activities and artifacts needed to prove compliance of the Cloud platform and all software deployed within it.

Your Mission-Critical Data is Secure in the Cloud

Your mission-critical data is stored in a controlled environment that is always available and always audit-ready. The ENSUR SaaS provides multiple redundant layers of security, tools, and services to protect the Cloud platform, keeping your data ultra-secure. Data in the cloud is encrypted and we employ 24x7x365 Anti-Intrusion defenses and log monitoring to keep hackers out and detect any anomalies.

Our Cyber/Information Security Program (C/ISP) is constantly evolving to meet the changing threat landscape and to align with current best practices. AWS provides among the most well-protected and well-defended environments in the industry, with security built into every layer of its infrastructure. AWS environments are continuously audited, with certifications from accreditation bodies across the globe.

What You Get with ENSUR SaaS (Software as a Service) Services


  • What is a managed cloud service?
    • A managed cloud service refers to the outsourcing of daily IT management for cloud-based services and technical support to third party resources who specialize in the maintenance of cloud environments.
  • What is a managed cloud services provider?
    • A managed cloud services provider manages not only the customers’ computing, storage, networks, and operating systems, but also the complex tools and application stacks that run on top of that infrastructure.
  • Is my data safe in the Cloud?
    • Absolutely! Consider the following in regard to the capabilities of DocXellent and our partner AWS vs. a typical organization:
      • AWS hires the very best security professionals in the world and invests millions in keeping their data centers protected, continuously upgrading their defenses even before new threats become known, and in general, being obsessively proactive about keeping in front of emerging threats. AWS continually tests its infrastructure; the results are summarized in compliance reports available to every customer through their Archive portal.
      • All traffic inside AWS is encrypted, all data stores and compute instance volumes can (and should) be encrypted, and access can be restricted to encrypted VPN traffic only.
      • When configured properly, every activity, every request, every configuration modification is logged, and virtually everything that happens can be monitored; alerts can be configured to be triggered based on standard events, or for any set of custom metrics as desired.
      • AWS allows users to define, enforce, and manage user access policies; DocXellent’s access management procedures are extremely restrictive and adhere to best practices including MFA, training requirements before granting access, and applying the principle of least privilege.
  • What are my cloud environment options?
    • When establishing your own isolated and segregated Virtual Private Cloud (VPC) within the ENSUR SaaS, you can specify in which region to base the VPC, with ENSUR, you can choose the specifications of the server(s) in regards to RAM and CPU, disk space, how often to make backups (default is twice daily) and which region to send backups to. In regard to other applications to be hosted in the ENSUR SaaS, our certified solutions architects will work with you to develop a high-performing environment tailored to your specific requirements – the possibilities are endless!
  • How durable is my data in the Cloud?
    • The ENSUR SaaS is powered by Amazon Web Services (AWS), the undisputed leader in Cloud Infrastructure-as-a-Service (IaaS) – AWS/ENSUR SaaS guarantee 99.99% uptime (not including operating system and application patches and updates), and data durability up to 99.999999999%! With ENSUR SaaS backup and disaster recovery procedures, all data is backed-up twice daily to another region, meaning that your data is available in at least two distinct regions at any given moment.
  • What advantages does a Cloud environment provide for disaster recovery scenarios?
    • A Cloud environment has a number of advantages over traditional on-premises data centers; however, perhaps the most important is cross-region replication of data/backups, allowing for quick recovery of your applications in the event of a failure of the datacenter. In general, it is much more likely that a local power or internet outage or other unforeseen event could take down a company’s servers/data center, as opposed to a whole redundant AWS Availability Zone/Region, meaning that accessibility to your data is much greater in the AWS cloud than a typical company’s servers/data center. Additionally, the ENSUR SaaS allows for relatively painless file-level backups for up to 14 days in case an important file has been accidentally deleted or modified, incremental SQL backups with a recovery point objective of 15 minutes, twice daily full backups, and annual backup and disaster recovery testing – all these disaster recovery benefits without having to involve your IT personnel!