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Compliant Hosting Solutions

CSV Solutions

Risk Based Cost Effective CSV

Plug and PlayByteGrid provides IT Regulatory Consulting services to Pharmaceutical, Biotech and Medical Device firms who are required to comply with: US 21 CFR Part 11 Electronic Record and Signatures, US & EU GMP Regulations, and the newly revised Eudralex Vol 4. Annex 11. We specialize in Risk Based Validation, utilizing industry guidance such as ISPE's GAMP 5 and PICS PI 011-3 Good Practices for Computerized Systems in Regulated "GxP."

We are truly the only end to end IT Compliance Services Provider. Two of our fully FDA Compliant Data Centers are minutes from FDA's Headquarters in Rockville. Boasting a "First in Class‟ Quality System that blends high technology with over 40 Policies, Procedures and Forms. We have created an Infrastructure solution that is application agnostic, allowing us to offer complete "plug and play‟ compliance.

Software, Lab & Automation Validation

GxP Soutions

  • Auditing: Our experienced audit team can help you evaluate projects, systems or documentation against internal or external standards and if required provide you with risk focused remediation strategies.
  • Software Compliance: Does your QA headcount need a temporary boost? The Sidus BioData team can act as QA document review for projects or individual systems.
  • Compliance Policies: Following industry and regulatory expectations our team can customize one, two or a whole suite of IT compliance procedures and policies to ensure your companies compliance.
  • PMA/510K Support: Our expert Regulatory Affairs team can support your software PMA/510k submission. We are experts in ISO62304, ISO14971 and can lead your team all the way from the Hazard Analysis to the Final Report.

GxP Training

We can provide your team with comprehensive GxP Training to ensure that they are versed in current testing practice and regulatory expectations.

IT Infrastructure

We provide a scalable, compliant IT solution positioned to meet your future growth needs. We are staffed with an ISACA certified quality team (CISA's and CRISC's) with over 25 years combined Life Science experience. We can host customer, FDA, or EU Regulatory Audits with ease. Our tried and true processes mean that we have your applications up and running quickly, efficiently and of course compliantly. We have achieved 99% uptime for the last 10 years.

  • Infrastructure: US/EU Qualified
  • Comprehensive Quality System
  • Staff 100% background checked and fully trained
  • Four-tiered Physical Access Security
  • Powerware 9350 500 KVA UPS
  • Redundant and Diverse Fiber Routes
  • Dedicated 2000A Electrical Power Feed – Hospital Grid
  • Kohler 380k VA Industrial Diesel Generator
  • 60T Redundant Integrated HVAC System
  • 610Mb/s Capacity of Connectivity

Part 11/Annex 11 Validation:

  • SAP
  • JD EDWARDS
  • HP QUALITY CENTER
  • TRACKWISE
  • E-INFOTREE
  • PHARMATRACE
  • CLINDEX
  • DOCUMENTUM
  • MASTER CONTROL
  • QUMAS
  • LIVELINK

Our Promise

ByteGrid partners will benefit from a cooperative model that eliminates the need for our customers to maintain a costly internal Data Center. We provide a plug and play EU/FDA GxP compliance program that allows access to the latest technology, significantly reduces energy costs and most importantly, allows funding and resources to remain focused on their core competencies.

Our Promise

For more information on CVS solutions, please contact us or call 855.495.0098.

 

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