GxP Course Topics
- HIPAA/HITECH Audits
- EMR/EHR Audits
- 21 CFR Part 11 Audits
- ANNEX 11 Audits
- SDLC Audits
- Software Project Audits
- Software Vendor Assessments
- Data Center Audits
- Software Quality Audits
- Regulatory GAP Analysis
- Clinical Workflow Analysis
Finding an auditor today isn't terribly difficult. Finding one with practical experience who has sat on the other side of the table is a different proposition entirely. In fact we believe that the best auditors have been audited themselves. Our senior audit team is unique in that as well as holding the coveted CISA designation every member of our team has held C-Level management positions in IT and software development. Our team has managed the expectations of clients, and the likes of the FDA, MHRA, sFDA, EHNAC and ISO registrars.
Whether you are considering a new ERP platform, a SaaS engagement or a custom development shop, ByteGrid can provide insightful, independent analysis of your chosen vendors process, tools and staff, and from that draw conclusions as to whether they are fit for task. Don't spend your entire capital budget on a bet, give us a week and we'll either give you piece of mind or food for thought. Our Auditors are thorough, thoughtful, technically astute and accurate.
Software houses are a mixed bag, some are good, some are great, some are awful. Ensuring that a real SDLC exists, that it's more than just 'shelfware' and that they actually act on it is where we come in. From Code Reviews and Unit Tests to final Release and Build we'll examine every step of their process to ensure that your end product has quality built in from day zero.
When FDA's Center for Biologics Evaluation and Research (CBER) wanted training on Computer Validation and 21 CFR part 11 audits they made one phone call. Our training was so well received we've been back again and again.
In the UK ByteGrid has performed high profile IT audit functions for NHS Scotland including the evaluation of bids on a £100m IT Procurement. Our carefully detailed evaluation of the vendor bid packages provided the NHS with additional insight and ensured that the taxpayers got their money's worth.
Our audits provide assurance that pre-established control objectives in the areas of regulatory compliance, security, confidentiality, integrity, and availability are in place. Additionally our IT Assurance team can work with an organization to identify and remediate risks at the customer site(s) to assure the integrity and security of critical data.
Our audit team has over 50 years combined experience evaluating, analyzing and remidating GxP Software and Systems and assessing compliance to both 21 CFR part 11 and the EU's Annex 11.
For our Software Development partners we provide an independent eye and evaluation of their current Life Cycle processes. Our Audit + Approach provides a baseline analysis of their development practices while offering remedial tips and practical solutions to maximize their value proposition.
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).
For more information on audits, please contact us or call 855.495.0098.
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