Validation: Trusted, Compliant, and Fit-for-use
Stressing about an upcoming audit? LabLynx can help your lab ensure that your systems track and document tests, results, and research, per the regulatory requirements, regardless of your lab’s industry.
Key Aspects of LIMS Software Validation
Software validation is the process of evaluating a software system or component during or at the end of the development process to determine whether it satisfies the specified requirements. LIMS validation can help laboratories ensure their software systems are fit for their intended use and meet regulatory requirements, helping to ensure the reliability, accuracy, and security of their testing methods and results. LabLynx recognizes that LIMS software validation is no simple task, requiring focus on:
Defining the Validation Scope
We’ll identify the specific software system or component that will be validated, as well as the specific requirements that it must meet.
Planning the Validation Process
We’ll create a plan for how the validation will be carried out, including which techniques and tools will be used and how the results will be documented.
Executing the Validation
LabLynx will carry out the validation tests and activities according to the plan, and we’ll collect and analyze the results.
Documenting the Validation Results
We’ll document the results of the validation tests and activities, including any issues or deficiencies that were identified.
Evaluating the Validation Results
LabLynx will review the validation results and determine whether the software system or component satisfies the specified requirements.
Maintaining the Validation Status
LabLynx will be sure to keep the validation documentation up to date and maintain the validated state of the software system or component over time.
LabLynx LIMS Software Validation
The LabLynx ELab laboratory information management system plays an essential role in the quality of your lab’s services. LabLynx can help validate your lab’s compliance with international quality standards, including ISO/IEC 17025 and ISO 15189. If you operate in a regulated industry, we can validate compliance with data security and best practices regulations such as CLIA, HIPAA, 21 CFR Part 11, GLP, and more.
Get Started Today
With LabLynx validation services, you can be certain your laboratory software performs as expected and has been rigorously tested to ensure conformance to industry guideline and regulations. Our validation services, of course, are just one important component of an overall package of LIMS software solutions and services to help your laboratory exceed its operational objectives while remaining lean and relevant in a highly competitive market. Find out how all the LabLynx solutions and services help give you more control over your lab’s operations.