With many years of successfully designing, developing and implementing electronic systems in a regulated environment for a wide array of clients, SeerPharma now offers these services for your software implementations.
SeerPharma can provide expert assistance and mentorship on IT projects, whether it is a new installation or an upgrade of an existing solution.
SeerPharma has been in discussions with a number of clients on providing such IT/QA project management and mentorship assistance. IT projects may vary in the methodologies they use to implement the end result, but in any methodology the following phases need to be addressed in some way.
Planning: The scope of the project needs to be defined and possibly split into several phases for implementation. The planning process will review your entire project scope and detail resources, tasks and deliverables. It needs to involve all the key project stakeholders to get agreement on tasks and timing. SeerPharma can assist with both project and validation activity planning.
Requirements: The requirements gathering exercise usually involves the key stakeholders and will document the business and system requirements. This may involve using the current process for initial discussion and exploring the business processes that you wish to implement in your IT solution. SeerPharma is able to assist with the requirements gathering or work with a business analyst.
Design: The IT vendor will usually produce a design/configuration specification that details the changes required to the system to deliver your requirements. The format of this shall be determined via discussions with the IT vendor. SeerPharma is able to facilitate discussion between technical and non-technical project resources and assist in design walkthroughs.
Configuration: The IT vendor or internal IT resources shall configure the solution as per the requirements/design and hold regular meetings/walkthroughs with the client to ensure agreement with the solution as it develops. SeerPharma is able to provide QA oversight on the configuration.
Testing: Varying degrees of testing may be required depending on the level of configuration. SeerPharma is able to assist with determining the level of testing required and with the development and execution of the testing as agreed.
Training: Suitable training material shall be developed and a training plan for your staff developed and delivered prior to the system going live. SeerPharma is able to assist with training development and with training rollout as required.
Support: Support procedures and responsibilities shall be determined between you and the IT vendor. SeerPharma is able to assist with the system handover process.
Data Migration: Although this is not a defined phase of the project, it is a function that needs to be assessed and developed prior to testing and going live. In some projects, data migration can be more complex than the system configuration. SeerPharma has been involved with many data migration exercises and can assist with the planning, data cleansing and data migration processes.
SeerPharma can provide expert assistance in any of the project phases defined as a means of:
- Achieving overall project success both as a functional solution and from a Quality Assurance/Validation perspective
- Training and mentoring your team on both IT project management / development and on Computer System Validation as part of a real project
Contact us if you are planning or in the process of deploying/changing an IT solution in your organisation.
This post comes from our July 2017 Journal. You may also be interested in:
- Case Study: IT Project Management Support - Automating Material Management Processes
- Effective Computer System Validation (CSV) in the Pharmaceutical and Medical Device Industries
- CSV Gap Assessment and Consulting for Pharmaceutical Distributor
- CSV Support for Medical Device Manufacturer
