Establishing audit readiness
During an internal audit at an international manufacturer of medical devices, a complex master data system developed in-house was found to have critical flaws in terms of its compliance, IT security and data integrity. The system manages the master data of tens of thousands of products. A worst-case scenario would have been product recalls due to inaccurate labeling, therefore the change and validation of the system became a top priority.
This starting point gave the project a high level of relevance and visibility within the company. Dr. Lars Schmiedeberg, ARCONDIS Manager with five years of project management experience in GxP-regulated environments, identified additional challenges:
- Time pressure – scheduled FDA inspections gave the project a tight deadline for closing the CAPA.
- Special software – before the project was officially launched, a script analysis was performed determining the level of complexity and the resulting impact on the project planning. This analysis clearly showed that the system developed by the client operated on its own business logic, which was very different from that used by standard software.
- Sought-after specialists – the project required specialists with long-standing experience in validating GxP-relevant systems as well as developers able to understand and develop the specific system code.
Planning and implementation success factors
In the planning phase the ARCONDIS project manager focused on two main priorities:
1. Identifying and addressing the risks
The need for extra development resources was addressed early on. The additional developers were able to work productively within a short time frame thanks to a sound onboarding procedure. This prevented disruptions to the development and ensured sufficient capacity of the critical path.
2. Turning the virtual, international project team into an efficient unit
The early integration of the QA and CSV departments as enablers within the project team was a key element of this step. This turned out to be extremely useful over the course of the project since the parallel launch of a new CSV framework required close coordination and adjustments to the validation strategy and documentation.
The long-time expertise in system validation performed at various pharmaceutical and medical device companies allowed ARCONDIS to implement the new CSV framework without losing valuable project time. The team also benefited from ARCONDIS’ detailed expertise of the medical device industry. This in-depth knowledge of relevant regulations, such as ISO 13485 and FDA 21 CFR part 11 and 820, significantly reduced the development effort and implementation of field definitions in the audit trail.
Transparency as a matter of principle
The proactive attitude of the team and regular, transparent communication with the steering committee played a crucial role in the success of the project. As a result of the intensive involvement of the stakeholders, challenges and solutions were discussed at an early stage preventing the need for costly rework later.
The solution was implemented in six months within budget and without critical findings.
The project completion was a cause for celebration: The customer now owns a validated system, and the critical CAPA was completed on time for the FDA inspection.
■ Dr. Lars Schmiedeberg