As a leader specializing in regulatory software testing and validation services, Arbour Group helps clients ensure that key business software systems are functional and in compliance with applicable regulations – including planning, protocol development, execution, and systems certification – to minimize business risk. Along with investment and financing strategies, new product development, market segmentation, pricing and other considerations, an important part of business risk management is directly related to a company's computer systems.
Our regulatory software validation services offer the distinct benefits of:
- Evaluating regulatory compliance
- Identifying associated risk factors
- Enhancing productivity through a reduction in application development and implementation time
- Capitalizing on the investment in software systems and benchmarking return on equity
- Improving schedule visibility, assuring milestone achievement, and project success
- Providing a qualified, third-party analysis of software systems
In order to facilitate the validation and testing of software systems in the most time-efficient and cost-effective manner possible, we follow a proven process of:
- Conducting an assessment of critical needs
- Drafting project specifications for client approval
- Setting finite objectives for each phase of the testing process
- Developing a matrix of software testing scripts tailored to meet those objectives
- Executing the appropriate software testing mechanisms utilizing commercial and proprietary tools
- Reporting the results of our comprehensive testing, including completeness metrics
- Repeating testing to accomodate changes resulting from ongoing upgrades and system maintenance
This validation and testing process not only focuses on software systems, but also evaluates the training and organization of the client’s personnel and the effectiveness of their operating procedures.
While technical considerations are an integral part of the regulatory software validation process, our professionals also offer the value-added benefit of viewing systems from a broad-based business perspective. This means that our results-oriented process not only ensures compliance and functionality, but also complements and reinforces the client’s marketing programs and new business initiatives and responds competitively to the needs of their customers.
Software Certification
Arbour Group has successfully provided software certification services to clients requiring a methodology for the testing of application software used by outside organizations. These outside organizations use their software to access the information repositories of various medical organizations.
In order to ensure submissions and access to the data warehouse achieve high accuracy, the certification of vendor software must be performed. Once software specifications are available, we develop the audit materials and testing methodology that will ensure that standards are maintained.
Certification Approach
The overall software validation process will include the following phases:
Audit Test Plan: Overall plan describing the objective, scope, certification process as well as the associated documentation
Audit Manuals: Manuals will include procedures for testing the software and core data elements. Software testing will validate the overall functionality of the system. Data element testing will validate the correctness and accuracy of the processed data in terms of recognizing valid and invalid items
Test Data Sets: Test cases to be used for executing the test procedures
Vendor Guide: Outline of the certification procedures, testing logistics and testing manuals will be distributed in advance
Audit Report: Actual results of testing will be documented. The summary of testing will focus on non-conformances. If no deviations are found, the report will serve as tangible assuranceCertification Environment
For certification testing purposes, it is essential that the test environment used for executing test protocols be equivalent to the commercial-grade environment (e.g., similar data setup, security, and internal controls). The software vendor should provide a test database so that data processed during testing does not corrupt any data.
Arbour Group is a premier provider of software testing services in the life sciences industry. We have the ability to effectively test purchased software, as well as custom developed applications. Our software testing specialists have the expertise and experience needed to ensure your information is accessible, and more importantly, protected.