Calibration is one of the critical parameters that regulatory bodies inspect. Calibration indicates the equipment’s accuracy and preciseness in performing measurements. The equipment should be calibrated with a regular calibration plan, and proper records should be maintained with relevant approvals and signatures. All the above-mentioned tasks related to calibration can be easily handled using QMS software such as Simpler QMS. It allows Sunshine to manage documentation for each piece of equipment, create tasks and assign them to relevant personnel, and send email notifications when the calibration activity becomes due.
Regular equipment maintenance is one of the most effective ways to ensure accurate and reliable lab results. Thus, Sunshine prepares a preventive maintenance plan and strictly sticks to it. After each preventive maintenance, complete all the documents, such as the maintenance checklist with proper authorization and signatures.
Inspectors inspect whether the staff working in the department is capable enough to carry out day-to-day routine activities such as safety principles, sample handling, and other activities. Laboratory management is responsible for conducting training programs. Using QMS software such as Simpler QMS to automate training is a worthwhile investment in this regard, as it allows Sunshine to efficiently handle all functions from planning training to execution. It allows Sunshine to easily schedule employee training by their respective designation and role. It tracks when training is due, distributes the needed training material, and sends notifications when new trainable material is released. Finally, at the end of the training, it generates a certificate of training with an electronic signature.
Lab data systems must be secure and withstand any hacking or breaching attempts. Appropriate user levels must be created with password protection. Additionally, it should include audit trails, backups, disaster recovery, as well as 21 CFR Part 11 compliant electronic signatures.
All these steps can maintain and ensure the accuracy and reliability of lab results. Sunshine Electronics keeps doing these all the time to meet all your requirements about our products.
Ensure that SOPs are updated every time a new process is implemented, or new equipment is installed. Similarly, laboratory staff should follow all the SOPs in their routine operations.
Ensure all the validation activities are completed with relevant documentation. For example, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) should be executed before using newly installed equipment.