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Compliant Hosting Solutions

IT Compliance Training

IT Compliance TrainingPractical Training for Maximum Results

ByteGrid has developed a full curriculum for Health IT – NHS Directive, HIPAA, HITECH, Software Development under ISO62304, PMA/510k submissions for Medical Device Software. IT Regulatory & Software Training against, 21 CFR Part 11, Part 210, Part 211 and EU. Vol 4. Annex 11. The excellence of our curriculum is matched only by the pedigree of our trainers. 

We are truly the only end to end IT Compliance Services Provider. Our fully 21 CFR Part 11 and Annex 11 Complaint Data Centers, two are located minutes from FDA’s Headquarters in Rockville, one in Silver Spring, MD and the other in Annapolis, MD . Boasting a First in Class Quality System that blends high technology with over 40 Policies, Procedures and Forms. We can provide hands-on real-time training for those customers tasked with maintaining or qualifying their regulated infrastructure.

GxP Training

  • P11/Annex11 Validation: Our experienced validation team has years of experience validating software to FDA/EU standards following our ‘risk-based’ validation methodology. Don’t create ‘Shelfware’ our endless libraries of binders, learn how to make your validation process work for the regulator and the business.
  • Product Verification & Validation: Learn how to effectively use ISO62304 to ensure compliance with both EU and FDA regulatory expectations. Our training includes navigating an ISO 14971 Risk Assessment and its application to software, requirements and specification creation, leading to the development of Verification & Validation Protocols. 
  • Medical Device Software: This training provides an overview documentation that the FDA recommends you include in premarket submissions for software devices, including stand-alone software applications and hardware-based devices that incorporate software.
  • Compliance Policies: Learn how to quickly create a full suite of IT compliance procedures and policies to ensure your company’s ongoing compliance.

Sales Training

We can provide your sales team with comprehensive GxP training to ensure that they are selling your product effectively in the regulated space.

Health IT

Health information technology (HIT) makes it possible for health care providers to better manage patient care through secure use and sharing of health information. Health IT includes the use of electronic health records (EHRs) instead of paper medical records to maintain people's health information. 

Learn what Health IT means to you. Our training in HIT benefits from actual cases studies undertaken with direct Heath Care Providers (Hospitals) and Health Service Providers. Learn how to conduct a full Private Health Information (PHI) dataflow analysis. Acquire the skills necessary to recognize PHI inputs, outputs, transactions steps and their necessary controls

GxP Course Topics

  • Validation Strategy Document
  • Risk Assessment
  • System Requirements Specification
  • System Configuration Specification
  • Installation Qualification HW
  • Installation Qualification SW
  • Validation Strategy Document
  • Risk Assessment
  • System Requirements Specification
  • System Configuration Specification
  • Installation Qualification HW
  • Installation Qualification SW

Health IT Course Topics

  • PHI Failure Modes Effects Analysis (FMEA)
  • EHR Systems Implementation Strategies
  • Controls Analysis
  • Controls Implementation
  • Global HIT Regulations (HHS, NHS, etc.)
  • Hardware Control
  • Data Security
  • Patient Rights

Our Promise

ByteGrid trainees will benefit from a cooperative, practical curriculum taught and developed by leading software compliance experts. Upon completion of one of our courses attendees receive a Certificate acknowledging their successful completion of the course.

All curriculum is independently audited and verified for accuracy by active Certified Information Systems Auditors (CISA).

Our Promise

For more information on IT compliance training, please contact us or call 855.495.0098.

 

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