“In a modern pharmaceutical enterprise, the IT infrastructure has an increasing impact on all processes associated with the development, manufacturing, storage and distribution of drug products. Because of this, the development, use and maintenance of the infrastructure, which forms a vital backbone on which the business depends, falls under the jurisdiction of regulatory authorities.” - IT Infrastructure Quality Assurance (GAMP Good Practice Guide, November 2000)
US Data Management assists our clients in ensuring their IT infrastructure is collecting and managing data reliably, efficiently and in compliance with industry and regulatory standards. US Data Management provides our clients in the Life Science Industry with industry proven Network Validation Engineers that have successfully assisted our clients in the Vendor Selection, Requirements Gathering, Design, Configuration, Implementation and Qualification of their IT infrastructures.
Our consultants have expertise in a wide range of industry recognized hardware and software components that compose an IT infrastructure that must support regulated and business critical systems. The following is a brief summary of some of the systems, areas, and/or components our consultants have assisted our clients with qualifying within their IT infrastructure:
- Network Inventory
- GAMP IT Gap Assessments
- GxP and 21 CFR Part 11 Assessments
- Risk Assessments
- Network Topology Diagrams
- Hardware and/or Software Configurations, Implementations and Qualifications for:
- Network Servers (Windows, Unix, Linux, Solaris, VmWare)
- Mail Servers (Exchange, Lotus Notes)
- Database Servers (Oracle, SQL Server, DB2)
- Terminal Servers (Citrix MetaFrame)
- Network Storage Systems (Symantec(Veritas), Trivoli, SAN)
- Network Appliances (switches, routers, wireless access points, hubs, ect. (Cisco Works))
- Security Devices(FireWall, DMZ, VPN, SecureId)
- VoIP Devices (Qualified due to Clinical IVRS Function)
- E2B and eCTD Gateways
- Active Directory Services (LDAP)
- Intranet/Internet Configurations (AntiVirus, SpyWare)
- Network Monitoring Tools (Cisco Works, Quest, MSCOM or MOM)
- Bug Tracking/Call Center Applications
- Standard Operating Procedures, Company Policies, Work Instructions
- Disaster Recovery Planning
- Fault Tolerance/Load Balance
- Training
- IT Change Control
- Maintenance
- Internal Audits and External Data Center Audits
- Develop Workstation Standards
- Startup and Shutdown Sequence and Analysis
- Data Center and IT Satellite Location Power, Security and Environmental Qualification
US Data Management can also provide our clients with GAMP IT Gap Assessments at the start of a project to give our clients a snapshot of were they need to be to ensure compliance with regulatory and industry standards.