At PMI, our multi-tiered computer
platform is a robust mix of servers supporting both paper
CRF double-entry and eCDM applications. Both applications
are Microsoft-based and very familiar to most computer users.
They are built specifically to the requirements of each clinical
study.
Our applications are characterized by 21 CFR Part 11 compliance,
as well as best practices related to ongoing management of
load balancing, bandwidth, and 24/7 availability.
Backup, Redundancy, Security
Our systems are designed to facilitate rapid restoration
of data in the unfortunate event of server failure. PMI’s
servers are located in a secure, environmentally controlled
area within our corporate facility and replicated
to our off-site data center. Our eCDM servers are located
at a state-of-the-art off-site colocation facility. Both
facilities utilize standard best practices with respect to
data security.
PMI facility
Building card access - controlled during non business
hours
Office - card access employees only or controlled login guest
pass
Motion detection alarms
Access controlled secure server room
Servers secured in locked cages within server room.
Climate controlled Server room
Off-site backup facility
Remote location facility specifications:
Building 55,000 square feet, single level, raised floor
Designed to Zone 4 earthquake specifications
Onsite Network Operations Center
Accessible 24x7x365
Space
Dedicated locked cage
Conditioned AC power
Clean, continuous power with redundancy and disaster recovery
configurations
Ethernet/fiber access to each row of cages
Staging area
Connectivity/Bandwidth
Vendor-neutral bandwidth
provider offering a blend of solution to provide connectivity.
Backbone circuits: multiple Gigabit Ethernet, OC12 (620Mbps),
and OC48 (2.48Gbps)
Electrical/Power
HVAC, N+1- redundant cooling
system
N+1 redundant power
Back-up batteries with 20 year design life
UPS is backed up by 1.25 MW Diesel Generator
UPS output capacity up to 4x375 KVA
Security
Single point of entry
24x7x365 monitoring
On-site security personnel
Remote controlled CCTV
Motion detection alarms
Combination access card/photo ID badges
Cages have combination or key locks
Fire Suppression
Industry leading VESDA
system for the detection of smoke and fire
Dual-interlocking pre-action fire suppression system, separated
by zones
Fully addressable fire alarm system
Environmental systems
Temperature maintained
at 68degrees F
Humidity maintained at 45% to 55%
Status/alarms for temperature, humidity, smoke/particulates
Raised floor and vented cabinets for improved air flow
Dual stage air filtering system
Automatic fail-over
24x7 Network Operations Center
The Network Operations
Center is manned with 24x7 on-site security personnel and
staffed by engineers who specialize in security, network monitoring,
fault monitoring, resolution, and disaster recovery. The entire
network is constantly monitored to ensure that the network
and equipment are online and available for data transfer.
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