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Quality & Regulatory Compliance

Services Offerings

Avigo follows a phased methodology for solution development, within the constraints of a disciplined, structured project management and quality compliance framework. The figure illustrates the various phases of Avigo methodology for developing a typical solution. Note that there are two separate testing categories through the implementation lifecycle – testing which occurs in the Build stage and testing that occurs during the validation of the system (in Deploy stage) as part of solution deployment. The former is SQA level testing and the latter is operational/performance qualification/user testing. Avigo broadly follows GAMP 4/5 methodology for developing computer system validation artifacts.

A key aspect of Avigo’s solution development methodology is that all the relevant regulatory and quality compliance requirements are incorporated in the development of the solution and the resultant documentation and artifacts are generated in accordance with these requirements.

Approach to Computer Systems Validation: Avigo’s solution development methodology ensures that all the relevant regulatory and quality requirements are met during the development of requirements, architecture design, solution implementation and rollout. Computer systems validation tasks are aimed towards completing the overall validation of systems and maintaining the validated state on a continual basis. Avigo believes that the key to an overall validation approach is taking a system-level approach to the problem, i.e., not to just validate the individual components of the process – software, hardware, user procedures – but to treat these components as part of an overall system that needs system-level validation. In this context, Avigo approaches computer system validation as a structured activity aimed towards demonstrating and documenting that the system requirements and design intent have been achieved.  Overall, Avigo follows a computer systems validation definition that is based on the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. Validation activities are structured towards testing against requirements, along with validation planning that is risk-driven to account for the fact that SQA testing typically is not exhaustive. Hence, Avigo follows GAMP recommended guidelines for mapping validation activities to the system development activities. In general, Avigo will follow a client’s corporate quality practices, SOPs, methodologies and guidelines towards the computer systems validation of solutions.


Avigo provides the following specific areas of expertise:

  • Patient recruitment and engagement technologies
  • Clinical registries, including QI registries, and Patient communities
  • Clinical trial protocol optimization and clinical trial data management, including CDISC transformations and biostatistical analysis
  • Regulatory information management, including, 
    • management of health authority interactions , CMC change assessments, contacts/commitments, submissions and registrations
    • IDMP data rationalization 
  • Drug Safety and Labeling solutions
  • Pharmaceutical R&D systems management
  • 21 CFR Part 11, HIPAA and cGxP compliance

Avigo’s core offerings are based on the practical implementation of integrated solutions that enhance decision-making capabilities in R&D. At a broad level, our offerings encompass requirements definition, product strategy, system architecture and design, development and integration, and operations support solutions.

Solution Methodology

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Services & Solutions

Our service offerings encompass the following:

  • Business Planning: Program and project management, solution selection, technology evaluation and selection, and rollout planning.
  • System Design and Development, and Integration: Requirement analysis, modeling, prototyping and design validation, design, implementation and system testing, system integration, technology migration, end-to-end performance testing and measurement.
  • Operations Support: Data services, application management, maintenance and support, computer system validation and quality compliance.