System Validation Packages are Now Available for all ClinPlus Systems.
Bound Brook, NJ (March 26, 2008) - DZS Software Solutions is pleased to announce that, with the completion of the validation package for ClinPlus Coding Version 3, we are now able to offer end-user validation packages to help our clients validate all of our systems in their own environment. Each package contains test plans, validation scripts, instructions, test data, listings and screen shots of expected results. All are designed to minimize implementation time by allowing our clients to complete the validation process quickly without getting bogged down in details of the software.
Each test plan is broken down into two parts; a 21 CFR Part 11 Test Plan and a System Test Plan. All test scripts are traceable to either the regulation or to our design specifications. Even the sections of 21 CFR Part 11 that must be handled procedurally rather than systematically are covered in the test plans so our clients can be assured that they are compliant with all regulations. Greg Ventura, Quality Assurance Manage at DZS says "These System Test Plans function like an Operational Qualification (OQ) in that they try to test as much of the system as possible in a manner that we think our clients would be likely to use the system. The 21 CFR Part 11 Test Plans function like an OQ and Stress test, since they test the robustness of the security of the system."
About ClinPlus Validation Packages
Packages are available for:
ClinPlus Data Management Version 3
ClinPlus Report Version 3.xx
ClinPlus Coding Version 3.xx
Please contact firstname.lastname@example.org for details. Validation services are also offered through our partner companies.
About DZS Software Solutions, Inc.
DZS Software Solutions, Inc. has been providing clinical trials software for data management & analysis to the pharmaceutical industry since 1996. Our ClinPlus suite of products provides the premium quality tools necessary for pharmaceutical companies, contract research organizations (CROs), biotech's, and medical device manufacturers to expedite clinical trials and meet the strict requirements of the FDA. From data collection, coding, analysis, and submission, ClinPlus provides the edge you need to get products to market faster.
Averaging 15 years each in the pharmaceutical industry, DZS software engineers bring several decades of experience in areas such as statistical analysis, clinical data management, and ADE/Drug coding. Our real world experience is incorporated in each system's design and is evident in the many features not found elsewhere.