As part of standard operating procedures, lab equipment validation is essential. It ensures that your equipment functions within the stipulated parameters and the manufacturer’s specifications. If you want to confirm the suitability of your equipment for production processes, it is vital to conduct validation. It ensures that critical components in your equipment are working consistently and provide the required quality output. When working in regulated industries such as pharmaceutical, medical, and food, it is a requirement to perform lab equipment validation.
Lab equipment validation can be daunting. However, there are expert ways to fasten the process. Here is an expert guide on how to make your lab equipment validation flawless and fast:
Deciding The Types and Period of Validation for Each Equipment
If you want to save time, make a program for each piece of equipment and its validation frequency. You can achieve this by classifying equipment from simple to complex. Some lab equipment must be calibrated, including chambers, autoclaves, freezers, and fridges. In addition, analytical equipment must be calibrated. Such equipment includes spectrophotometers, GCs, and HPLCs. Other equipment that requires validation includes lab software and customized devices.
The number of equipment set points and parameters determines the simplicity or complexity. Equipment validation must be carried out according to usage and industry regulations.
Periods of Lab Equipment Validation
- When the equipment is new, new equipment requires validation to confirm its critical components with the manufacturer’s specifications. Some equipment might deviate in precision during transportation and installation.
- After transferring your equipment to a new location, environmental factors might affect the functioning of the equipment.
- Perform validation after a repair or maintenance of equipment.
- Always validate your equipment when you have implemented a new formula or method.
- Validate your equipment following the recommendations of the manufacturer. An equipment manual has the process and frequency of validation indicated.
Expediting Lab Equipment Validation
Most third-party companies validate their equipment. The process is usually fast due to specialization and the availability of resources. However, depending on your ability, it might not be feasible in the long run. You can reduce the cost by carrying out in-house lab equipment validation. Define a template and a protocol for each equipment validation. Your template must have detailed procedures and be consistent. If you have a qualified validation engineer, design a future reference template to use as the equipment ages.
Always document all your validation steps and reports. Validation is a strict process. It must adhere to the equipment audit requirements. To reduce the workload, use validation software instead of paper documentation. The software will help you comply with the standards and adhere to validation intervals.
Using Lab Management Systems
If you operate several types of equipment, you will have a high volume of instrument data. The equipment data always require heavy analysis to comply with government regulations. Having a lab management system helps you fasten the process. Most of the time, paper management is very inefficient. Most modern labs have an information management system. These systems include data management systems and electronic notebooks. You can incorporate asset management, inventory management, and scientific information systems if you have a larger scope.
Since these systems are computerized, you will improve productivity, efficiency, workflow, integrity, and accuracy of the data. The systems have various interfaces, functions, and options that a paper-based system cannot handle. Furthermore, you will enjoy the automated and integrated functions within a single dashboard. It helps you keep track and manage your validation.
The main disadvantage of paper-based validation is that it lacks accuracy and integrity. The transcription process is always full of errors. It takes a lot of effort to retrieve information from archives with splintered records. Due to the intensity of the work, it is costly. Moreover, recent regulations call for computerized validation processes.
Following Regulatory Rules
Lab equipment validation strategy must be the regulatory requirements. Your strategies must be compliant with various rules from time to time. As the technology grows, there is always a transition in the data integrity guidance. You must follow the FDA rules as they are updated. You must have an electronic device that can generate, store, and index all validation data. Your system must have a computerized approval mechanism. These systems always generate an e-signature after successful validation.
These rules aim to ensure compliance, increase efficiency, and reduce audit times. The regulatory authorities can easily perform their investigations and provide you with validation approval. These systems are a requirement in controlled operations, such as pharmaceuticals and food laboratories.
Full Data Integration
Full data integration improves the productivity of your lab equipment validation processes. Your data integration needs to be efficient and allow the smooth addition of new information. The integration has an interface with all validation solutions.
Full data integration combines audits, e-signatures, reports, internal and external validations, and all workflow information. The integration provides paperless lab equipment validation with analytics, repository and compliance system. The main advantage of full integration is the streamlining and efficiency of validation operations. Furthermore, you will have faster decision-making and reduce the overall costs. It allows you to solve new challenges faster.
Lab equipment validation is an important process. It allows you to check the quality of your equipment and reduce impending production risks. It is also a government requirement through the FDA. Use integrated software for all the processes to make your validation simpler and faster. Biotechnical Services, Inc. has the premier technology to install a system with high integrity and strict compliance with your lab. We are registered, accredited, and ISO certified to offer lab validation solutions. Contact us today.