Importance of Regulatory Standards
There has been a noticeable escalation in the audits of laboratories to ensure that they comply with industry standards and regulatory guidelines. Implementing a LIMS not only helps with automating laboratory processes but also with compliance and data management. Since the first FDA rule that was formalized in 1997, 21 CFR Part 11 guidelines concerning electronic records, compliance, and data integrity have become indispensable. The implications of non-compliance may vary from hefty penalties to cancellation of a license. Hence, the laboratory managers must ensure that the LIMS complies and aligns with the latest laboratory standards.
The application of LIMS in an academic laboratory ensures that all raw data generated from measuring and analytical instruments, processed data, and analyzed data is easily accessible, interpretable, non-duplicate, and reproducible.
Regulatory Compliance
The regulatory requirements vary based on the industry, such as clinical diagnostics, cannabis, hemp, food and beverage, oil and gas, and agriculture testing laboratories. Some of the regulatory guidelines and standards for laboratories are as follows:
- Clinical Laboratory Improvement Amendments (CLIA)
- 21 CFR Part 11
- GMP/GLP/GCP/GDocP
- EU GDPR
- Health Insurance Portability and Accountability Act (HIPAA)
- ISO/IEC 17025:2017
- Food Safety Modernization Act (FSMA)
How Does a LIMS Help?
A robust LIMS benefits laboratories in various processes such as sample accessioning, workflow management, instrument integration, test result management, and report generation. A LIMS effectively helps in managing data and tracking any changes made, which is the need of the hour for a majority of the laboratories. A LIMS automates and streamlines the workflows, minimizing the need for manual data transfer from one system to another, which in turn reduces transcription errors and redundancy. Data integrity with LIMS can be authenticated by a secure audit trail. The audit trail functionality captures laboratory activities with a date and time stamp along with other details, such as the user ID or name, reason for the change, which makes it much easier to present the data during an audit. However, in laboratories using paper-based data management systems, such information can be missed out because it is difficult to manually record every laboratory activity. A quality LIMS can indicate non-conforming activities ahead of an audit and helps in taking corrective measures.
LIMS Validation is Crucial for Compliance
For laboratories, validation is the mainstay without which compliance and data integrity cannot come into the picture which in turn impacts the analysis. Hence, a LIMS must go through proper QA/QC checks or validation to ensure the proper functioning of the software, helping laboratories remain aligned with the regulatory requirements, industry standards, and best practices. The auditors and regulators verify the process of LIMS implementation, hence laboratory managers must ensure validation documents are received from the LIMS vendor ahead of the audit, even if the LIMS has undergone a version upgrade or customization. Hence the laboratories must not cut corners on LIMS validation. Validating a LIMS authenticates that the system performs sample management efficiently.
The following three aspects of a LIMS helps laboratories comply with the regulatory guidelines.
1. Organization
2. Visualization
3. Automation
Organization
A LIMS digitally transforms an organization and eliminates data silos. A LIMS software records and manages laboratory data and makes the data easily accessible. Laboratory data includes sample data, test results, certificates of analysis (CoA), standard operating procedures (SOPs), study data, sample processing and storage data. This makes it easy to search the data and make confident decisions surrounding all aspects of the laboratory.
Visualization
A LIMS can maintain accurate records of the chain of custody that helps in tracking samples from the time a sample is collected through the time samples are disposed of. A LIMS also generates barcodes for samples for complete traceability throughout the sample life cycle. The data is then compiled into visually represented reports which are made available at all points to the laboratory managers to make informed decisions for seamless laboratory operations. A LIMS also helps in analyzing and plotting trends across a set of samples and enables laboratory managers to identify issues and take appropriate corrective actions.
Automation
A LIMS helps in flagging out any discrepancies that could lead to non-compliance. The use of LIMS software effectively automates laboratory workflows, ruling out any human errors. A LIMS maintains data integrity and facilitates data interoperability by integration with analytical instruments and software. Furthermore, a LIMS enforces laboratory staff to follow SOPs and helps laboratory managers to track deviations from SOPs and quickly identify non-conforming activities.
Conclusion
Regulators and auditors keep an eye on whether a LIMS is compliant with the industry standards and best practices. Hence, LIMS vendors need to keep in mind the laboratory needs to ensure that the software complies with the latest regulations and guidelines. Non-compliance can lead to several internal and external costs and can also tarnish the reputation of the company due to product failure.