Are you using consultants for your IT project in pharma? Here’s how to maintain compliance and oversight.

Why consultants can create compliance challenges

Using external consultants for IT projects in pharma is common and can bring valuable expertise and flexibility. However, the use of consultants can also create significant challenges regarding compliance with GxP requirements. This is primarily due to the fact that roles and responsibilities between internal employees and external consultants are not always clearly defined.

In practice, compliance issues often arise because external consultants are not fully familiar with the company's internal procedures or the specific regulatory requirements that apply. Companies often underestimate how important it is to ensure that the consultants are properly integrated into the compliance processes.

Consequences of poor integration of consultants

If the integration of external consultants is not handled correctly, it can lead to serious compliance issues. This can be seen in audit findings from the FDA and EMA, which often point out deficiencies in the management and oversight of external vendors and consultants. The result can be costly and time-consuming corrective actions, as well as the risk of regulatory sanctions.

Moreover, poor integration of consultants can lead to issues with data integrity and documentation. If consultants work without a clear framework and clear procedures, the risk of errors and omissions increases, which can affect the quality and validity of the company's data and documentation.

Effective tools to maintain compliance

To avoid these challenges, it is important for the company to establish clear guidelines for the use of external consultants right from the project's start. The guidelines must precisely define roles, responsibilities, and expectations for the consultants' work and compliance obligations.

One of the most effective methods is to draft detailed contracts and collaboration agreements that clearly describe the compliance requirements and responsibilities for both the company and the consultant. The agreements should include requirements for documentation, data integrity, training, and reporting.

Continuous training and close collaboration between internal teams and consultants are also important. Consultants should be regularly informed about the company's compliance requirements and procedures, and there should be a clear communication channel between internal employees and consultants. This ensures that any issues can be identified and addressed quickly.

Another crucial factor is ongoing monitoring and auditing of the consultants' work. By regularly conducting internal audits and quality assurance, the company can ensure that the consultants' work meets compliance requirements and that any deficiencies are quickly identified and corrected.

If you would like to learn more about how to best integrate external consultants into GxP-regulated IT projects without compromising compliance, please feel free to reach out to us so we can have an informal discussion.