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
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. Inadequate Objectives 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. Untrained Staff 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. Conclusion 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. Source - https://www.biotechserv.com/possible-reasons-why-lab-validation-projects-fail/
0 Comments
Lab equipment validation is essential for the compliance of regulatory bodies and ensuring that the instruments meet the required standards. It is also important to ensure that the equipment meets the required quality for a specific lab process. When validating lab equipment, ensure that you follow the manufacturer’s specifications. The validation results must be consistent with various equipment parameters. However, guaranteeing each critical component of the equipment is suitable takes more time. When working in highly regulated sectors such as pharmacy, medical, and food industries, the validation process must follow FDA stringent measures.
Due to the complex process of lab equipment validation, lab users must devise measures to improve efficiency. When you streamline the validation process, getting faster results becomes easier. Here are Ways to Get Faster Instruments Validation Results 1. Deciding The Type of Equipment to Validate and Their Schedule The best way of getting validation results is to make a validation schedule for each instrument. It is easier to prepare for the validation of various devices using a clear program. You can achieve this by categorizing your equipment from simple instruments to more complicated ones. In addition, you can create a specific time for validating instruments in various classes. Such classes may include instruments such as analytical equipment, chambers, autoclaves, and spectrophotometers. If you want to simplify your validation process, perform the tasks at specific intervals or events. You can decide to perform lab equipment validation during installation, maintenance, or moving to a new location. Another instance of lab equipment validation is when a new protocol is introduced. 2. Outsourcing Lab Equipment Validation Process If you want faster validation results, contact a professional third-party company. These companies have the necessary resources for various validation processes. Performing in-house validation can be tedious and time-consuming. You might also incur additional costs for validation equipment. However, if you want to make your in-house validation faster, draft validation templates to be used by your staff. The templates will consist of the procedures and the components to be validated at a particular time. For consistency and accuracy, draft clear validation documentation. Your documentation needs to have organized protocols for faster results. Moreover, you can invest in validation software to track your process, automate schedules and provide paperless results. 3. Introduce an Integrated System It is important to introduce an analytical technology for your validation process. An integrated system will save your time and reduce various validation risks. Introducing a management system will allow you to eliminate paper records that are time-consuming and have transcription errors. A management system is useful when tracking various instruments, assets, and validation schedules. With the growth of technology, you can automatically compute and network your validation data. In addition, software solutions are reliable, accurate, and sustainable. 4. Avoid Paperwork A paperless system is seamless, accurate, and efficient. In addition, various regulatory bodies, such as the FDA, requires that you set up a paperless system. Managing validation records is difficult and full of errors. Furthermore, retrieving past validation records is tedious and may lead to data loss. An automated system is faster and increases the number of validation tasks daily. Moreover, a system rids you of enormous junk papers in your office. 5. Integrate Your Validation Processes Every system needs integrity and simplicity. You can achieve this by making various backups of your electronic records. An integrated system is also important when extracting previous validation records from your database. Unlike a manual form, an electronic system is searchable, saving your instrument validation time. For faster decision-making, you can integrate your validation records into software for smooth data transfer. In addition, if you operate several laboratories, you can receive validation reports from a centralized electronic system. The system simplifies your management aspects and ensures that your processes are on track. To streamline the validation workflow, ensure that you train your staff using various analytical instruments. However, consider a full data management software to consolidate every aspect of your instrument validation. The software is important when sharing validation reports outside sources and improving the integrity of your work. Furthermore, the software will also provide validation data accessibility to all your staff. The process will boost your lab productivity and foster collaboration with various stakeholders. With integrated software, you can use barcodes for a simpler interpretation of data. Labeling instrument components allows faster validation than relying on manual records. The result is a fully functional validation system. 6. Adhere to Regulatory Requirements Lab equipment validation requires compliance with various regulatory bodies. Regulatory requirements are always updated for integrity purposes. It is important that you follow these regulatory updates to make your validation faster. Lab owners who fail to follow these requirements are normally fined and ordered to repeat the process. In recent times, the FDA has introduced various electronic validation protocols. Using these protocols allows you to easily manage, analyze and generate validation certificates from electronic data. These measures provide efficiency and save time, making your general validation results faster. 7. Full Integration of Lab Process Integrating all your lab process is necessary. However, you should ensure that various processes work seamlessly and simultaneously without bottlenecks. An efficient lab has different software that works harmoniously without interference. These processes improve your productivity in aspects such as lab equipment validation. Furthermore, you can integrate your software with a third-party solution for easier communication. Enabling integration with a third-party solution eliminates the need to exchange validation data using paperwork. Moreover, a fully integrated lab is valuable for automatic analysis, searchable databases, and compliance with various stakeholders. Conclusion Lab equipment validation protocols require accuracy and integrity. Your lab operations must be flexible and efficient if you want faster results. However, you may have several challenges validating your instruments in time. You can contact a specialized third-party validation company for accurate and speedier results. Biotechnical Services, Inc. has enough premier resources for every type of lab equipment validation. Source - https://www.biotechserv.com/7-ways-to-get-faster-results-in-lab-instruments-validation/ Automated lab equipment calibration reduces human error and uncertainty in measurements. Human errors occur during the tracking of the calibration process and manual data entry. In addition, automated calibration eliminates irregularity, traceability, non-compliance, and collaboration problems. You need to invest in a management software solution when automating your calibration processes. Biotechnical Services, Inc. uses new-age technology to perform automated lab equipment calibration in Los Angeles. Automated calibration is useful for managing, automating, or storing your equipment calibration details.
These processes include optimizing, analyzing, scheduling, and generating calibration reports and certificates. Furthermore, automating your lab calibration will eliminate equipment errors and running costs and boost your organization’s performance. Elements of An Automated Calibration Dial and Digital Indicators Comparators and digital indicators are mostly used to calibrate measuring devices in the manufacturing sector. These dial indicators have boosted the traction of digital calibration. However, parallax errors can occur when a calibration technician observes the measurements. With the advancement and automation of metrology processes, CCD cameras can be installed in a computer system for precise and consistent reading. The automated process helps reduce viewing angle errors and eliminates the technician’s eyestrain. Automated Dial Indicators In recent times, there has been automation of various metrology aspects. The technology has allowed the integration of dial indicators and CCD cameras into the calibration systems. However, this technology might be a bit expensive for small labs but provides a good ROI in the long run. The calibration process involves connecting CCD cameras at specific dial indicator points. The cameras will obtain clear readings of equipment graduations and display them in a digital indicator. Furthermore, this system is attached to a motorized calibrator that is fully automated. The calibration station performs automated equipment checks and prints the reports and calibration certificate. Biotechnical Services, Inc. has invested in premier automatic indicators for precise lab equipment calibration in Los Angeles. Automated Aids Automated aids are useful when calibrating gauge blocks and other equipment. Calibrating your gauge blocks frequently allows you to attain measurement standards. You need hand-eye coordination and concentration when measuring these gauge blocks. However, an automated calibration system has helped eliminate transcription errors when measuring the gauge blocks. Calibration technicians use computer systems to store calibration files which are used in automating the recording of measurement deviations. In addition, the system performs calibration offsets before producing the final reports. Since it is difficult to set equipment in a center line, measurement templates are used to automate the process. Computer-Aided Techniques Equipment such as master rings and master discs require very tight tolerance when taking their measurements. Several measures are performed to attain the needed standards when calibrating these gages. These processes are labor intensive when setting the standards, comparator configurations, and performing comparative measurements. In recent times, there has been the introduction of automated measuring systems. These systems contain CNC cables that are integrated into the equipment on calibrations. Computer-aided techniques have eliminated the tiresome tasks and errors of universal-length machines. Using the integrated systems, an operator dials a button, and the computer performs the adjustments. Operator errors are eliminated when using motorized tables and CNC systems. When in need of lab equipment in Los Angeles, Biotechnical Services, Inc. provides integrated computer measurements to eliminate uncertainty. These automated systems provide accurate calibration for your critical equipment. Automated Calibration Benefits to Service Companies Streamlining and Automation of Workflows Most service companies have invested in cloud-based management systems such as CMS tools. These tools help calibration technicians and managers streamline the workflow for managerial and administrative tasks. Data stored in a cloud system allows various stakeholders in service companies to make qualified and informed decisions. These decisions include the calibration process and intervals. Furthermore, these systems have been useful in eliminating the tiresome manual calibration procedures. A computer-defined workflow removes the use of paperwork and provides consistency in calibration. Improving Calibration Efficiency Since an integrated system is entirely automated, it provides more efficiency when calibrating various equipment. An automatic process has led to the elimination of labor-intensive manual calibration. The system allows calibration technicians to conduct other core tasks such as strategic analysis. Lowering Measurement Costs Service companies can lower their costs by using software in calibration management. Automated systems have eliminated the use of paperwork when recording calibration data. Furthermore, management systems provide a faster, more accurate, and easy interface for the calibration process. Calibration managers can use measurement data in the system to check trends and make decisions that will lower costs. Compliance and Standardization When performing equipment calibration, service companies must meet certain industry standards. The FDA mostly sets these standards to reflect the ISO requirements of each piece of equipment. A CMS solution helps in the calibration management and tracking of these standards and compliance. Effective Management Using an automated system calibration, managers can monitor various key performance indicators. Monitoring these performances is simpler since the system provides real-time calibration data. The data is useful for service companies when analyzing their resources, such as the installed equipment. Recording Calibration Records and Data Since the system is integrated, calibration plans and strategies can be tracked automatically. The calibration database is also useful when storing equipment data and calibration histories. Furthermore, an automated system can centralize all calibration data and automatically generate equipment reports. Increasing the Lifespan of Equipment Automated systems are useful when tracking equipment’s calibration cycle and maintenance schedule. Planning these schedules using software provides equipment longevity and lower repair or replacement costs. A cloud-based system offers real-time information for the maintenance of various equipment, unlike a manual record. Conclusion An automated calibration system such as a CMS solution is essential for defining performance objectives. Using an integrated system, a company can analyze the state of lab equipment, calibration equipment, and the right software. Furthermore, an automated system helps in proper planning and reducing performance downtime. Biotechnical Services, Inc. uses dedicated software to increase the productivity of your equipment. Contact us today for efficient lab equipment calibration in Los Angeles. Source - https://www.biotechserv.com/automated-calibration-how-it-is-beneficial-for-service-companies/ |
AuthorWrite something about yourself. No need to be fancy, just an overview. Archives
November 2022
Categories |