How Do You Digitize Data Traceability?
It’s imperative to make research data FAIR, and "FAIR" begins with findability. But without a reliable chemical inventory management system (CIMS), it’s a challenge to find the lab data you need—including when lab managers or regulatory bodies demand to see those data on the spot. Motion waste then skyrockets due to the time sink of recapturing old data into the formats required. If this cannot be done on time or completely, you may fall out of compliance with the rules and regulations that govern your lab.
Meeting the demands of the regulators
Properly documenting expiration dates saves researchers the time and effort of repeating experiments that may have used expired chemicals and aids in root cause analysis. But manual inventory management is often inadequate for this purpose. Typos and oversights happen, bottle labels can become smudged, ink on paper can fade and Excel offers no version control.
The need for compliance heightens the criticality of these problems. Regulatory bodies such as the U.S. Food and Drug Administration and European Medicines Agency mandate a full “paper trail” of every consumable in the lab going back to its registration date, including time stamps and user names for each usage. These records are especially important if, say, a manufacturing batch fails due to a faulty reagent.
Not only is consumable traceability vital to any systematic review of all materials used in a failed workflow, but the lack thereof in and of itself is a violation of compliance. Failure to provide a complete paper trail during an audit can result in a warning—or a fine of up to 30% of your company’s annual revenue.
A 2020 survey we conducted with C&EN found that 81% of respondents’ labs followed one or more types of regulations. But barely half said they felt prepared for an unannounced audit. Many said they’d be largely unprepared.
The 21 CFR Part 11–compliant LANEXO® Inventory Manager can help you prepare for regulatory scrutiny. Simple scanning of RFID labels produces rapid, reliable and reproducible digital data capture, permitting real-time tracking of all consumables data. Human error is decreased, and the quality, reliability and traceability of your compliance documentation are increased.
Every consumable registered into the system is matched with a time-stamped, secure and searchable audit trail, documenting its lifecycle from receipt to disposal for greater audit readiness. You can export the audit trail and forward it to the regulatory authorities if necessary. And user access cards provide each user with a unique digital signature, which is also captured in the audit trail.
Keeping a safe lab
Data unfindability also hinders safe chemical storage. If your inventory system doesn’t include storage rules or incompatibility checks, your staff is more likely to store incompatible substances together. The same is true if reagent safety data sheets (SDS), which include instructions for proper storage, are maintained apart from the actual consumables.
The overwhelming double burden of research projects and inventory maintenance on scientists is another factor that can jeopardize your safety standards. Your researchers may be knowledgeable and trained on storage requirements, but they don’t have the time to devote to spotting incompatibilities, and they may end up taking “shortcuts” when putting chemicals away. Also note that one survey respondent reported finding “incompatible chemicals stored in proximity due to lack of space.”
These challenges pose risks to the safety of your lab workers, of the neighborhood and of the environment. And, because safety officers examine storage locations during audits to rule out potential hazards, such lapses also put you at risk of noncompliance.
Storage safety is another facet of compliance that the LANEXO® Inventory Manager can help you attain. It puts digital SDS right at your scientists’ fingertips. And if a consumable can’t safely be stored with the other substances in a cabinet, or if there’s another noncompliance issue with the location, you get an instant alert. You can customize the default Mixed Storage Rules in the system as needed. Real-time storage monitoring, and automatic alerts in case of deviation, improve safety and regulatory compliance.