The pharmaceutical industry is highly regulated to ensure that the quality, efficacy and safety of medicines delivered to patients is maintained. When pharma companies look to implement computer systems in their facilities, the system needs to have functionality that facilitates compliance with regulations. Laboratory information management systems are often used in pharmaceutical quality control laboratories to increase efficiencies, standardise practices and maintain compliance. In this blog, we cover LabHQ’s best LIMS features for the helping companies comply with pharma regulations.
As a regulatory requirement of 21 CFR Part 11, audit trails provide data security and traceability. LabHQ audits all creation, modification and deletion of data and records these actions against a user name, date and time. In LabHQ, the user can search the audit trail by user, object (such as product, test method, sample, etc.), date or by all options. The audit trail is then presented as a pdf which can be easily reviewed before a sample is approved or shared with auditors during an inspection if required.
In addition to audit trails, LabHQ can add further traceability for those users who have the Stock Management and Equipment Maintenance modules. With these LabHQ modules configured, Data Administrators can assign stock and equipment to test methods. This allows Analysts to select a batch of stock and the relevant equipment they used during testing for enhanced traceability. Therefore, if a result is confirmed out of specification due to stock or faulty equipment, the User can easily run a report on LabHQ to find all samples affected which makes the investigation quicker and easier to manage.
For routine QC testing, it is important that results are checked against specification and reported as pass or fail on the certificate of analysis. LabHQ allows user to create target, upper and lower limits to automatically assess results against specification. Once results are entered in LabHQ, a visual indication is given if the result falls within specification, within warning limits or outside of specification. The management of specifications is also version controlled so that the latest version of the spec is applied when samples are registered. Previous versions of the spec are also maintained and easily retrievable.
As another requirement of 21 CFR Part 11, LabHQ LIMS unambiguously links electronic records with the associated electronic signature. Users apply an electronic signature in the system by entering their user password to confirm an action such as entering or approving test results or changes to static data such as test methods or product specifications.
As more pharmaceutical companies move to electronic systems for retaining records, it is important that data is protected and secured from potential loss or corruption. Data should be retained for shelf-life plus one year, and therefore, a process for data back-up must be in place and validated before operationally used in a live production environment. LabHQ LIMS as a hosted solution delivers data back-up automatically. The process and management of data back-up is included with the monthly rental, and the standard data back-up is every 2 hours. Requirements for validating the back-up process is addressed during the deployment project of LabHQ so that sufficient evidence that back-up requirements are met can be supplied.
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