Pharmaceutical manufacturing is a highly regulated industry that requires strict adherence to quality and regulatory requirements. However, staffing shortages or a backlog of projects can put companies at risk of non-compliance and costly delays. In such cases, staff augmentation services can provide an effective solution for pharmaceutical manufacturers to meet their CSV needs. In this blog post, we will discuss how staff augmentation services assisted a client with a backlog of projects.
A Pharma client with manufacturing and R&D facilities in Colorado, focused on delivering its commitments with steadfast reliability while maintaining a creative and nimble approach, needed experienced resources to support the development and execution of validation activities for several projects, processes, and systems.
After understanding the client’s needs, our team concluded the best engagement model was a staff augmentation solution, deploying the right expertise at the right time for the clients’ different Computer System Validation needs that included, but were not limited to: Change Controls, New instruments validation, risk analysis, reviewing designing specs, reviewing vendor assessments and IQ/OQ documents, Computer Software Assurance and Computer Systems Validation.
During the project, we helped the client to fill their staffing gaps and execute the backlog of work that had been causing delays in their drug development process. Our experts provided guidance and executed the work needed for complete compliance with quality and regulatory needs while clearing the existent validation projects backlog. Our SMEs took a risk-based approach to update the Maximo calibration system, the Deacom ERP system, and other change control orders requested by the client. Our proactive approach and project management skills made us the point of knowledge for all the client’s validation needs.
With the partnership, the client was able to complete their backlog of work within a few months, achieving compliance and peace of mind. The client appreciated the flexibility of PV’s services, as they were able to scale up or down as needed, depending on their staffing needs and project requirements.
With over 30 years of experience, Performance Validation has built a reputation for providing exceptional services that help companies to navigate the complex FDA-regulated landscape and achieve their goals. One of the services that PV provides is staff augmentation, where experienced validation professionals are provided to clients to help them fill staffing gaps to complete critical projects.
In conclusion, staff augmentation is an essential service for pharmaceutical manufacturers facing staffing issues or experiencing a backlog of projects. By partnering with PV, clients can benefit from experienced validation professionals, industry knowledge, and best practices that help them achieve their goals efficiently and effectively.
If you are experiencing staff shortages or have a backlog of CSV projects, schedule a call today with our SMEs to get you back on schedule.