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 Pharmaceutical Quality Management Cloud-based Hosting Svs

ARCCSM (Audit Ready Compliant Cloud) is the industry leading 21 CFR Part 11 compliant hosting solution for the regulated life science industry. ARCC SM enables software cloud hosting of: Continued Process Verification (CVP), Quality Management Systems (QMS), Electronic Document Management Systems (EDMS), electronic Common Technical Documents (eCTD), FDA electronic submission gateway applications and Laboratory Information Management System (LIMS) in a private and secure cloud environment. ARCCSM is the most economical and fastest way organizations can implement, validate and maintain compliant systems “off-the-shelf.”  ARCCSM serves the needs of small to large organizations, and easily scales with, and configures to, organizational needs.

Hosted Software Solutions

ARCCSM can host most any compliant software solution, and has already established partnership programs to ease selection and implementation for clients. The Windshire Group works with clients to identify the best software solution for their needs and can assist with implementation and validation. The solution may be either through an existing ARCCSM partner or a client’s preferred supplier. The ARCCSM environment can host multiple applications within the same environment to simplify management and maintenance. Solutions range from low cost, simpler solutions typically more suited for smaller companies, to full enterprise systems capable of supporting large multi-national companies.

Contact The Windshire Group for other options.

Data Integrity and Security

ARCCSM installations have been successfully audited many times by regulatory agencies and clients. Data integrity issues are limited from the use of pre-defined Installation Qualification (IQ) validation packages and protocols, and ARCCSM’s FDA 21 CFR Part 11 compliant secure, private environment. Messages, documents and intellectual property are stored in a safe and secure environment (SSAE16 colocation facility). Other features include:

  • Files, documents and messages are backed up daily
  • Easy restoration
  • UPS and Diesel generation
  • Protected by a pre-action sprinkler system
  • Integrated card reader security system
  • Closed circuit TV throughout the facility
  • Exterior security cameras
  • 24/7 Security Service
  • 2 hour fire wall surrounds entire data center

Advantages and Value

  • Lower complexity and risk from procuring, deploying and maintaining system
  • Seamless integration with customer’s existing qualified or non-qualified environment
  • ARCCSM support for development, test and live production environments
  • Rapidly and easily scalable to match capability and cost with business need
  • Significantly lower ownership, maintenance and lifecycle costs
  • Very rapidly deployable
  • Highly cost effective
  • ARCCSM audit support

Infrastructure, Policies, and Procedures

  • Other details on ARCCSM facility, power management, environmental and procedural controls can be found in the downloadable file. Click Here for Download

Client Testimonial

“ARCCSM services and products are a huge time and money saver that our organization depends on, year in and year out. We couldn’t live without it. We have been using ARCCSM to host a document management and eCTD publishing systems for many years.  All of our customers use RegDocs365 on SharePoint in the  cloud where they author, review and approve documents before handing them releasing them for publishing.  We use Adlib PDF Enterprise for MS Word to PDF conversion and OCR of PDF files.  We assemble submissions with  docuBridge or EXTEDO eCTD Manager.  We validate eCTD submissions with LORENZ eValidator and GlobalSubmit Validate+Load.  We upload submissions to FDA and Health Canada portals  from our production account.  ARCCSM qualified cloud enables us to quickly add new customer projects, assures the content for submission publishing is secure, enables customers to continue to edit documents while my team is assembling submissions and adding external hyperlinks, and provides high-speed performance because the cloud also includes all the applications my customers need to author/edit MS Word files, remediate PDF files and review eCTD submissions.  Before ARCCSM, our customers were losing documents when their authors’ computers hard disks failed that were not backed up, were using different incompatible versions of MS Word, were manually converting MS Word to PDF files that were not compliant with agency specifications, and were uploading/downloading large files that sometimes took hours to complete. ARCCSM solved almost all of our worst headaches.” – CEO of E-submissions and EDMS Integrator

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