Most lab validation projects fail due to inefficient organizational communication. In other instances, validation experts fail to set validation schedules and protocols. Validation protocols are important in establishing standard operating procedures. When these procedures are not followed, the project will likely fail. Other times, the lab management may forget to set a clear budget for validation tasks. When these instances occur, lab managers use shortcuts due to time or costs. However, to save yourself from these hassles, you can hire the services of a licensed validation company. Biotechnical Services, Inc. is a professional company conducting lab equipment validation in San Francisco.
What is a Lab Equipment Validation?
A lab equipment validation is documented evidence proving that various instruments have been tested and consistently work as expected. Equipment validations are normally conducted at specific schedules following the manufacturer’s specifications. When lab validation projects are not performed properly, there is always a risk of failure.
Some of The Reasons Contributing to Validation Failure
- Failure to perform equipment validation for lab systems used for validation purposes.
- Performing validations without proper manual or documentation from the manufacturer.
- Failing to follow the expected Standard Operating Procedures (SOPs) for validations.
- Performing lab validations without proper objectives on the process.
- When the risks associated with a validation process are not taken into account.
Consult Biotechnical Services, Inc. if you have doubts about validating your lab projects. We offer precise lab equipment validation in San Francisco and its environs.
Factors That Lead to Lab Validation Failure
Lack of Communication
One leading cause of lab validation failure is gaps in organizational communication. Companies that fail to communicate effectively on lab processes may not perform their validations efficiently. To avoid this scenario, conduct regular meetings with your technical staff. You can also consider writing memos and minutes to your team members on the expectations. Having constant communication will allow proper planning. In addition, you will also address pending issues that might affect your validation. Performance issues are normally discussed in the next meetings. Furthermore, ensure that all the stakeholders attend these meetings. Moreover, ensure that you formulate critical paths for your lab validation processes.
If your company lacks clear validation objectives and methodologies, the chances of project failure are high. Before starting any validation projects, ensure that your team members have a clear task aim. A concise report containing the project plan will ensure that each staff knows their specific role. It also ensures that each technician is trained on various aspects of project execution plans. Furthermore, ensure that you clear any unambiguity on different project parts.
It is good to ensure you have all the system and user requirements before starting any project. A robust and well-defined plan has a clear outline indicating the scope of the tasks ahead. In addition, ensure that you prepare your testing team by training them and assigning them specific duties. Failure to plan on these aspects is the start of validation project failure.
Lack of Consistent Engagement of Stakeholders
For your validation project to succeed, ensure that you engage with all the stakeholders consistently. Some of these stakeholders are technicians, quality personnel, and project managers. Frequent engagement with these teams ensures that you align all the project aspects. In addition, you will eliminate the chances of human error and various changes in the scope of your project. You will also define and review your objectives and project goals during these engagements. Furthermore, your stakeholders will provide concise recommendations on the best validation practices.
Absence of Risk Management
The absence of sufficient and proactive measures to eliminate imminent risk is one of the reasons for project failure. Most lab managers ignore this aspect of validation protocol. When conducting pre-validation meetings, most stakeholders fail to identify the potential risk. It is important to exhaust all the risks for these analyses and how to mitigate them. Furthermore, the management must set up a supplementary budget for the potential dangers. Having all these aspects in place will enable you to act proactively instead of reactively. When you encounter a risk factor during the implementation without prior preparedness, you will likely lose control of your validation process. It is important that you plan early and publish risk management documentation. Finally, educate all your staff on the action to take in case of a risky situation.
However, if your team cannot sustain these risks, ensure that you consult a third-party validation company. Biotechnical Services, In. has comprehensive risk mitigation measures for the success of your lab validation in San Francisco.
Conducting lab validation projects is a critical process. The process is centric and requires consistent and efficient preparation and execution. If you want to validate your project successfully, focus on specific components and elements of the project. You can treat factors such as leadership, team members, and other stakeholders separately for their particular roles. Train each entity on its specific roles and adhere to its regulations. Since the process is critical, ensure that you educate all team members on the importance of complying with the set rules.
In addition, train your staff on how to follow the validation SOPs correctly. These SOPs ensure that there is no error or confusion during the execution of the project. Consider using an automated validation process to avoid risks from poorly trained staff.
Lack of Real-Time Management
Most of the time, the lab management fails to monitor the current status or progress of the validation process. Failure to observe these processes might lead to irreversible risks or time and cost increases. It is important to give your management a dashboard view of real-time progress during the whole process of validation.
Lab validation projects are critical processes that require proper objectives, planning, and scope definition. It is also important to conduct risk management and the acceptance criteria for such activities. Biotechnical Services, Inc. has sufficient technology and resources for various validation tasks. Contact us today for your lab equipment validation in San Francisco.