Connecting CRO'S to IT Regulatory Resources
ByteGrid provides IT Regulatory Consulting services to CRO's who are required to comply with: US 21 CFR Part 11 Electronic Record and Signatures, US GCP Regulations, and Article 29 of Commission Directive 2005/28/EC, Good Clinical Practices (GCP).
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" Environments.
We are truly the only end to end IT Compliance Services Provider. Two of our fully FDA Complaint Data Centers, located in Annapolis, MD and Silver Spring, MD, are minutes from FDA's Headquarters in Rockville, MD. Boasting a 'First in Class' Quality System that blends high technology with over 50 Policies, Procedures and Forms. We have created an Infrastructure solution that is application agnostic, allowing us the capability to host every CDMS on the market today.
- 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 ByteGrid 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.
- Procedure Analysis: We can analyze your existing policies and procedures to ensure their applicability and robustness in the regulatory context.
Data Center Qualification Services
We can qualify your existing data center to ensure EU/FDA Compliance. We closely adhere to the GAMP IT Infrastructure Good Practice Guide. In addition one of ByteGrid's principals currently chairs the Global GAMP IT Infrastructure Special Interest Group.
We provide a scalable, compliant IT solution positioned to meet your future growth needs. We are staffed with an ISACA certified quality team (CISAs and CRISCs) with over 25 years combined Life Science experience.
We can host customer, FDA, or EU Regulatory Audits with ease. Our tried and true processes means that we have your CDMS and other 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
21 CFR Part 11 Validation:
- Oracle Clinical
- PhOSCo (IBM Clinware)
- Master Control
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 CRO funding and resources to remain focused on their R&D and Trials.