Applying ALCOA in a Regulated Lab
From method development to signing off on a clinical report, the Platform for Science can be utilized to streamline lab processes and ensure data integrity in your regulated laboratory. A key factor for ensuring data integrity in a regulated lab is being able to state that your data is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA), all inherent capabilities of the Platform for Science. The Platform for Science enables users to comply with Good Laboratory and Clinical Practices while eliminating the need for stacks of paper to reproduce a study.
Attributable -- Data in a Regulated Lab Environment
Put simply, regulatory agencies require all data to be linked to its source. This requirement applies to many facets of a regulated lab starting with sample chain of custody. The Platform for Science allows users to easily track who did what and when, by providing an audit trail and event log.
During an audit, a Principal Investigator (PI) may need to quickly provide an auditor with the life cycle of a clinical sample. With the Platform for Science, the PI can easily provide the sample chain of custody. This entails: when the sample was received including all relevant shipping information, when the sample underwent analysis, how many freeze thaw cycles have been performed, who moved the sample, and when the sample was moved. The Marketplace includes a variety of accessioning applications built on the Platform for Science to enable these workflows.
Legible -- Notes for Data Integrity
Quality data must be legible for it to be considered fit for use in a regulated lab. This requirement can be surprisingly difficult to adhere to, as busy scientists may quickly scribble down notes or signatures. By using an electronic system to capture data and signatures, it’s easier for a lab to meet this requirement. Using the Platform for Science an end user can easily prompt his or her manager via an automated email to review and witness an experiment, and capture electronic signatures throughout the workflow.
Contemporaneous – Recording Scientific Observations
When working in a lab, it is possible for the end user to be distracted by multiple tasks and forget to write down when an observation occurred, or when data was collected. A main element of data quality is ensuring that data is recorded at the time the observation is made, 21 CFR 130(e) states “…data shall be recorded directly, promptly, and legibly…”
The Platform for Science helps labs to meet these criteria, by using the Core SDMS (Scientific Data Management System). The Core SDMS provides an automated data capture from instruments. The Core SDMS monitors folders that are located on your network file system for automated data capture. As the Core SDMS detects the presence of a new file it will load the file into the Platform for Science for archiving and will then invoke the appropriate file parser. By using the Core SDMS the laboratory can easily automate the scientific data capture and lessen the risk of manual errors.
Original – Raw Data Accuracy
Raw data is the first, and therefore most accurate and reliable recording of information. Raw data files are stored in the Platform for Science, which serves as a repository for the information. The Core ELN (Electronic Lab Notebook) provides version history, electronic signatures, and audit logs to support any record retention and data archival policies, and supports regulatory compliance. By reviewing the data and information stored in the Core ELN, auditors can see when data was created, if the data was modified, and who made the modifications.
The ability to quickly access raw data can be extremely valuable when evaluating sample re-analysis. For example, if a sample failed during a Pharmacokinetic (PK) assay, an auditor or PI would be able to track each time the sample was run (and by whom), what the result from each run was, and what the final reported PK concentration for the sample was. This reduces the need to find this information across many lab notebooks and local instrument computers.
Accurate – Maintaining Data Integrity
Accuracy is one of the key variables an auditor is looking for when closing out a study. The auditor must be able to verify that the reported results accurately reflect the raw data. To ensure that the Platform for Science is accurately capturing and reporting data, a software validation package and validation services are available. The Validation Package includes a Validation Plan, protocol templates for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and a Validation Summary Report.
Benefits of Using the Platform for Science
In an audit situation, an auditor can ask the PI to provide all sample raw data, sample chain of custody, and signature approvals with timestamps for a study. With the Platform for Science, the PI can quickly and easily point the auditor to this data. The ability to have this information readily available in one system reduces risk of frustration and irritation by an auditor, and enables a smooth audit process.
The Platform for Science can help to ensure that your laboratory’s data is Attributable, Legible, Contemporaneous, Original, and Accurate. The burden of relying on a paper system to ensure these variables have been achieved, is removed by allowing the Platform for Science to easily capture and report your lab’s data.
Laura Trudeau is a Project Manager at Core Informatics. This is part of our blog series supported by the Core Customer Success group. Please contact Laura at firstname.lastname@example.org with any thoughts you would like to share.