Epista can help. Our pragmatic approach identifies where to set the bar so quality levels fit both your regulatory requirements and your business objectives. We’ll help you figure out where you are now and where you want to go. Then, we’ll help you get there.
Ask us about our services:
Project Quality Workshop. Engage project and system stakeholders to align the Quality organization with the ERP project and define the overall scope. We know from experience that clearly defining and basing the Quality Mandate within the Project and Organizational Management team is a prerequisite for success.
Quality Assurance Workshops. To bridge the gap between stakeholders, we hold a workshop with representatives from the IT, Quality and Line-Of-Business departments. Using our experience from many similar projects, we facilitate common understanding of business and quality requirements.
Project Planning. Based on the Quality Mandate and QA Workshop, a Quality and/or a Validation Plan is developed to define related activities for the ERP implementation project. These activities are integrated within the project plan to ensure close alignment with other project activities.
ERP Implementation. During implementation, we assign a consultant experienced in computerized system validation to the project team, responsible for all validation. Quality related activities are carried out according to the Quality Plan and Validation Plan. This includes activities such as quality training of project members, requirement definition, risk assessment, document review, source code review, traceability and establishment of validation documentation.
ERP Validation. We apply the general GAMP approach to the V-model (unless another approach has been agreed upon). This means that we require a complete and approved set of system specifications before we move on to system verification. System verification takes place in a designated test environment according to pre-approved test plans. We will also establish and maintain traceability between specification and test activities throughout the project.
We enjoy sharing our knowledge and are happy to discuss advancing regulatory compliance in your company: