Bioanalytical LIMS Software | BioLIMS

Bioanalytical Management

What BioLIMS Is Built to Do

BioLIMS is CORPEX's bioanalytical laboratory management system, designed for bioequivalence and bioavailability studies. It covers the complete workflow from study protocol through sample collection, analysis, and final report generation, so a study doesn't move between three different tools on its way to a report.

It integrates with analytical instruments and keeps a full audit trail across that workflow, which is the part a GLP inspection actually looks at: not whether the study was run correctly, but whether the record proves it.

Who Runs a Bioequivalence Study on BioLIMS

Contract research organizations, and generic manufacturers proving equivalence to a reference product.

A bioequivalence study compares how a test formulation and a reference product behave in the body, usually by tracking drug concentration in plasma samples over time. A bioavailability study asks a related question: how much of an administered dose actually reaches systemic circulation, and how fast. Both depend on strict chain of custody for every sample, from a study subject, through collection, storage, and shipment, to the analytical instrument, because a broken chain undermines the result regardless of how good the analytical method is.

BioLIMS serves as the centralized record for that chain: sample collection, storage conditions, and analysis are logged against the study protocol, and dissolution testing and other release-related methods are managed alongside the bioanalytical work. Digitizing that trail removes the reliance on manual record-keeping across a study that can run for months and involve dozens of subjects and thousands of samples.

The GLP Requirement Behind a Bioanalytical Report

Why a sponsor or regulator trusts the number in the final report.

Good Laboratory Practice (GLP) governs how non-clinical and bioanalytical studies are planned, run, and reported: a written protocol has to exist before the study starts, raw data has to be retained and attributable to the person who generated it, and deviations from the protocol have to be documented rather than quietly absorbed into the result. Regulators reviewing a bioequivalence submission are, in large part, reviewing whether the study can be reconstructed from its records.

BioLIMS supports that reconstruction with an audit trail across the sample lifecycle, electronic signatures on key steps, and instrument integration that captures analytical results directly rather than through manual transcription. For labs working across borders, the same controls are also built to FDA 21 CFR Part 11 and EGAC ISO/IEC 17025 expectations, so a study run for an Egyptian sponsor holds up to an export-market review as well.

Study Design and Sample Types BioLIMS Tracks

A bioequivalence study generates more moving parts than a routine QC test.

Protocol and design

Most bioequivalence studies use a crossover design, where each subject receives both the test and reference product in separate periods. BioLIMS holds the protocol, subject list, and period/sequence assignment as the reference every subsequent sample is checked against.

Sample collection

Pre-dose and multiple post-dose plasma samples are logged against their scheduled collection time, subject, and period, with storage conditions recorded so a deviation in a freezer temperature or a missed time point is visible rather than absorbed silently into the dataset.

Analytical batches

Samples are analyzed in batches alongside calibration standards and quality control samples. BioLIMS ties each result back to its batch and instrument run, which is what a reviewer checks first when validating a bioanalytical dataset.

From Protocol to Report

BioLIMS acts as a centralized database across the study: sample collection and storage are logged first, analytical results follow through instrument integration, and the final report draws on that same underlying data rather than being assembled separately at the end.

Analysts record and retrieve information tied to sample collection, storage, and analysis throughout the study, which keeps the record consistent even when a study runs across several sample collection visits and multiple analytical batches.

The final report typically summarizes pharmacokinetic parameters such as peak concentration (Cmax), time to peak concentration (Tmax), and area under the concentration-time curve (AUC) for each subject and period. Because those parameters are calculated from the same concentration data BioLIMS already holds against each sample, the report ties directly back to the audit trail rather than being rebuilt from a separate spreadsheet at the end of the study.

What BioLIMS Changes for a Bioanalytical Lab

Regulatory compliance: a complete audit trail supports GLP and reduces the administrative work of proving it during an inspection.
Automated documentation: data documentation and tracking are captured as the study runs, not reconstructed afterward.
Customized reporting: reports are generated from the same underlying study data instead of assembled by hand each time.
One workflow: sample and inventory management, instrument interfacing, and collaboration between analysts sit in a single system.
Fewer transcription errors: instrument integration captures analytical results directly, instead of an analyst re-typing a chromatography or dissolution reading from a printout into a spreadsheet.

How BioLIMS Connects to the Rest of the Lab

Bioprocessing, QC, and validation notes.

Working in biopharmaceutical manufacturing rather than a bioanalytical study lab? Explore our bioprocessing LIMS for upstream, downstream, and bioanalytical workflows under 21 CFR Part 11. A lab that also runs routine QC testing alongside bioanalytical work typically pairs BioLIMS with SilverLIMS, CORPEX's QC LIMS, since both sit on the same underlying CORPEX LIMS sample-management engine. Once a study report is finalized, it commonly feeds into a regulatory dossier submission, which is where RENOVA RDX, CORPEX's regulatory affairs platform, archives the bioequivalence study alongside the rest of the CTD file.

BioLIMS is implemented and supported in Arabic and English for Egyptian laboratories working toward Egyptian Drug Authority (EDA) GMP expectations or EGAC accreditation under ISO/IEC 17025; see LIMS software in Egypt for the local detail. Because deploying BioLIMS is itself a computerized system change, every implementation is backed by computer system validation (CSV), with IQ/OQ/PQ documentation ready before the system goes live.

Frequently Asked Questions About BioLIMS

What is BioLIMS used for?

BioLIMS is CORPEX's bioanalytical LIMS for bioequivalence and bioavailability studies. It manages the complete workflow from study protocol through sample collection, analysis, and final report generation.

Is BioLIMS GLP compliant?

BioLIMS is designed to support Good Laboratory Practice (GLP) requirements, with a full audit trail across the sample lifecycle, electronic signatures on key steps, and instrument integration that captures results directly rather than through manual entry.

What is the difference between BioLIMS and SilverLIMS?

BioLIMS is built for bioanalytical and bioequivalence study workflows, while SilverLIMS is CORPEX's QC LIMS for routine pharmaceutical raw-material, in-process, and finished-product testing. Both run on the same underlying CORPEX LIMS sample-management engine and can be deployed together.

Does BioLIMS support dissolution testing?

Yes. Dissolution testing and related release methods are managed alongside the bioanalytical workflow in BioLIMS, with instrument integration for the analytical data behind each result.

Is BioLIMS available for biopharmaceutical manufacturing rather than study labs?

For upstream, downstream, and bioanalytical workflows in biopharmaceutical manufacturing, CORPEX offers a dedicated bioprocessing LIMS built to 21 CFR Part 11.

Is BioLIMS supported in Egypt with Arabic language support?

Yes. CORPEX is an Egyptian company, and BioLIMS implementation, training, and support are available in Arabic and English for laboratories working toward EDA GMP or EGAC ISO/IEC 17025 accreditation.

BioLIMS™ — Bioanalytical LIMS Software