Implementing any software solution into your business can be challenging and time-consuming, if not properly organized. ISI’s Software service offerings concentrate on both pre- and post-implementation phases for ISI products as well as individualized technical services to help optimize the performance of current environments.
ISI offers the following software services to help our customers implement new solutions on time and within budget.
Software Implementations
- Pre-implementation gap analyses, to outline system hardware and software compatibility and to assess “eCTD readiness”
- On-site installation and configuration of any one of our applications, by an ISI product implementation expert. Assistance with the setup of client databases is typically included.
- Multiple-phase installation efforts to match the customer’s validation needs (i.e., Sandbox-Test / Validation-QA / Production). These efforts always include the execution of ISI-specific Install Qualification Scripts (IQ).
System Validation Services
Implementing software within any regulated environment requires the proper system validation to ensure compliance with both regulatory agencies and the client’s Quality Assurance standards. Because of these challenges, ISI also conducts validation and qualification-related tasks that are necessary for complete and successful production deployment. These services may include, but are not limited to:
- Creating and executing test scripts
- Writing validation documents
- Managing validation protocols
- Complying with agency and our customer’s quality assurance standards
Standard validation services can be provided or ISI can customize a validation rollout package. As part of the overall qualification process, ISI provides a fully-validated document package that includes installation qualifications and functional User Acceptance scripts. These items may be used as-is, or customized to meet specific testing needs throughout the phases of IQ, OQ, and PQ. Additionally, validation protocol material such as usability requirements, traceability matrices, and other compliance planning literature can be provided or even written by ISI.
Technical Consulting Services
ISI will work alongside customers to deliver a variety of technical services and assistance, for any product deployment. Our goal is to provide the most reliable, scalable, and high-performance environment possible, helping to optimize processes and systems that meet and exceed our client’s expectations.
- Administrative and technical configuration training
- Design and architecture for new database systems
- Fine tuning of ISI integrations with CDM systems such as Oracle Clinical or Clintrials
- Fine tuning of ISI integrations with EDM systems such as Documentum or Livelink.
Technical Project Management
All ISI software service projects are led by a skilled project manager whose responsibility is to ensure on-time delivery during each phase of the project plan. Whether it is in the project planning stage, the development of an educational program or final product deployment stages, ISI Project Managers are heavily experienced and ready to manage any type of project.