21 CFR Part 11
Electronic records & signatures
Signatures re-authenticate with the password and record name, time and meaning; password policy, idle timeout and optional two-factor sign-in.
CORPEX LIMS · Laboratory Information Management
Every sample, every result, one record an inspector can trust.
CORPEX LIMS is laboratory information management software for QC, microbiology, stability and water laboratories. Samples, worksheets, calculations, investigations, equipment and certificates share one sample record, one audit trail and one set of electronic signatures, powered by Oracle Database.
- Step 1Registered
- Step 2Assigned
- Step 3In progress
- Step 4Pending review
- Step 5Technically reviewed
- Step 6Approved
Every sample walks the same six steps. A hold or an investigation pauses it and returns it to the step it left; approval records the usage decision.
- 10
- ModulesSamples to materials
- 6
- Sample stepsRegistered to approved
- 8
- SPC run rulesApplied to every trend
- 5
- LanguagesIncluding Arabic, right to left
End to End
From Request to Certificate, One Record
Each step adds to the same sample record, so the number on the certificate is the number the analyst entered and the reviewer signed.
- RequestSamples
- RegisterSamples
- AllocateSamples
- TestELN / LES
- CalculateChemistry · Micro
- ReviewELN / LES
- InvestigateOOS & CAPA
- Approve & certifySamples · CoA
- TrendAnalytics
The Modules
Ten Modules, Shown in the Real Application
Pick a module to see its screen. Every screenshot is taken from CORPEX LIMS running on demo data. Each module is available on its own or as part of the platform.
01 / 10
Samples & QC testing
Register a sample once; the system works out what it owes.
- Analysis requests, registration, barcode labels and a register filtered by status, section and due date
- The governing specification builds the test panel and sets the due date
- Work allocation refuses analysts whose qualification is incomplete
- Certificates of Analysis built from an approved template, after the release decision
Explore Samples & QC testing · for bioanalytical labs · Bioprocessing LIMS · CFast CoA software
02 / 10
ELN / LES worksheets
The worksheet is the record an inspector actually reads.
- Worksheets raised from the template the test maps to, for QC execution and R&D studies
- Formulas calculate as inputs are filled, with no code execution in the engine
- Review and approval are separate electronic signatures; nobody reviews their own worksheet
- Equipment readings arrive checksummed, with the original file kept
03 / 10
Chemistry & HPLC
The pharmacopoeial maths lives in the software, not a spreadsheet.
- Test catalogue with lab section, result type, decimals and standard hours
- Assay by HPLC against two reference standards, with %RSD per preparation
- Dissolution staged S1, S2, S3 (USP <711>) and content uniformity acceptance value (USP <905>)
- HPLC injection data imported from a chromatogram PDF or CSV, reviewed before saving
04 / 10
Microbiology & EM
Microbiology testing and environmental monitoring on one schedule.
- Microbial limits, sterility, pathogen detection, growth promotion and suitability tests
- TAMC / TYMC calculator and subculture management
- EM sessions judged against alert and action limits; an excursion raises an investigation
- Isolate register with macroscopic and microscopic identification
05 / 10
Stability
Years of pull points, none of them missed.
- Stability programmes approved by QA, protocols and protocol templates
- Pull points generated from the protocol; a due pull raises its own sample
- Calendar, chamber space, containers and chamber excursions per study
- ICH Q1E shelf-life evaluation, out-of-trend register and ICH zone advisor
06 / 10
Water
Every point, every loop, on the cadence the plan sets.
- Water sampling points with grade (PW, WFI and more), loop and point class
- Sampling schedules that generate the day’s samples, with routine points moved off non-working days
- Alert, action and specification limits, with consecutive excursions flagged
- Monitoring programmes approved before they run, and a printable water sampling plan
07 / 10
Investigations & CAPA
An out-of-specification result is a record, not a bad day.
- A failing result or EM excursion raises its own investigation, one per failing test
- Phase Ia, Ib and II in order; the full investigation stays locked until QA signs off Phase Ia
- The original suspect result can never be excluded or edited
- Approved invalidation raises the CAPA with root cause, owner, due date and effectiveness check
08 / 10
Method Validation
A validation plan you cannot change after seeing the results.
- ICH Q2(R2) Table 1 fills in the characteristics and acceptance criteria
- %RSD, correlation, recovery and detection limits computed, never typed
- The approved protocol is frozen by the database; the author cannot approve it
- Study pipeline from setup to approved report, with items needing attention
09 / 10
Equipment & Calibration
Out of calibration means refused, not warned.
- Equipment register with calibration status, last calibrated and next due
- Calibration schedules that compute their own next date, with escalation when late
- A failed calibration names every test the instrument touched since it last passed
- Maintenance checklists from templates that take spare parts out of stock
10 / 10
Materials & Inventory
A reagent opened in March expires sooner than the bottle says.
- Chemicals, reference standards, reagents, supplies, containers and preparations
- Material receiving with quarantine and release status
- In-use expiry set the moment a container is opened; the earliest date wins
- Volumetric solutions standardised, and reorder alerts when usable stock runs low
Shelf Life (ICH Q1E)
The data decides the shelf life, not the label
Every batch of a product at one storage condition is evaluated together, the way ICH Q1E asks. CORPEX LIMS tests whether the batches can be pooled and takes the shelf life from the 95 % one-sided confidence bound, not the fitted line through the middle of the data.
- Shelf life claimed against shelf life the data supports, per test.
- Out-of-trend and out-of-specification points marked on the chart.
- An ICH Q1A(R2) checklist that names any study missing a required fact.
Audit Trail
“Show me it hasn’t been changed.”
Every create, change and delete is written by the system, with the old and new value, the user, the time and the reason. Each entry carries a fingerprint of the one before it, and the database refuses to update, delete or truncate the trail.
- Logins, failed sign-ins and failed signatures in the same chain.
- Chain verification on demand, with any break reported.
- Read-only for everyone, filterable and exportable for the inspector.
Statistical Process Control
Drift shows up while the result still passes
Control limits come from the moving range, and Nelson’s eight run rules are applied to every series. A result inside specification can still be the ninth in a row on one side of the mean, and that is the signal a limit check alone never gives you.
- Individuals and moving-range charts per item and test.
- Cpk and Ppk with a plain verdict.
- Filter by analyst or instrument to find the source.
Inspection Ready
What an Inspector Checks in a QC Laboratory
Is the reported result the original result?
Raw files are fingerprinted at upload and checked on every read, and they cannot be deleted. An OOS result is never edited or excluded.
Who changed what, when, and why?
Every change carries the user, the time, the old and new value and the reason, in a trail the database will not let anyone alter.
Was the analyst qualified and the instrument calibrated?
Work cannot be allocated to an unqualified analyst, and an instrument past its calibration date is refused, not just flagged.
Who approved the release, and could they?
Review and approval are separate electronic signatures with name, time and meaning; the person who did the work cannot approve it.
Global Compliance
Built Around the Rules Laboratories Are Inspected Against
The technical controls in CORPEX LIMS map to the regulations and standards below. Each card names the control that answers it.
EU GMP Annex 11
Computerised systems
Role-based access checked against the code, a hash-chained audit trail the database protects, and workflows that can add controls but never remove them.
ISO/IEC 17025
Testing laboratory competence
Analyst qualification gates work allocation, out-of-calibration equipment is refused, and methods are validated in the system.
ALCOA+ · PIC/S PI 041
Data integrity
Raw data checksummed and undeletable, controlled records superseded rather than overwritten, and every entry attributable to a user and a time.
FDA OOS Guidance
Investigating OOS results
Phase Ia, Ib and II in order, the original result never excluded, and invalidation only on a QA-approved root cause.
ICH Q1A(R2) · Q1E
Stability testing and evaluation
Each study is checked for the facts Q1A(R2) requires, and shelf life is estimated from the 95 % one-sided confidence bound.
ICH Q2(R2)
Analytical procedure validation
Characteristics drawn from Table 1, results computed, and the approved protocol frozen by a database trigger.
EU GMP Annex 1
Environmental monitoring
Viable counts judged against alert and action limits snapshotted onto each round; an action-level count raises an investigation.
USP <711> · <905>
Dissolution and uniformity
Staged dissolution acceptance and the content uniformity acceptance value computed; an incomplete stage gets no verdict.
GAMP 5
Risk-based validation
Validated by the CORPEX team with a risk-based approach and IQ, OQ and PQ documentation; see CSV services.
Designed to the expectations of
- US FDAUnited States
- EMAEuropean Union
- MHRAUnited Kingdom
- PIC/SInspection co-operation scheme
- ICHHarmonised guidelines
- ISOLaboratory accreditation
Compliance belongs to the validated system and the procedures around it. CORPEX LIMS supplies the technical controls, and the CORPEX validation team documents them for your inspection or accreditation assessment.
LIMS Software
LIMS for Regulated Laboratories, Wherever You Test
A laboratory information management system is the software of record for a testing lab: it logs every sample, tracks it through each analytical step, stores the result against the method and specification that applies, and produces the certificate at the end. CORPEX LIMS does that for pharmaceutical QC and stability labs, food, water and chemical labs, and microbiology and bioanalytical facilities, with the ELN in the same system rather than a second product. It works alongside CORPEX-eQMS and CORPEX-ERP, and is validated like any GxP computerized system through computer system validation (CSV).
In the browser, powered by Oracle Database
Runs in any modern browser on desktops and tablets, on an Oracle Database back end.
Five interface languages
English, Spanish, Portuguese, Czech and Arabic, with right-to-left layout for Arabic.
Connected to your lab data
CORPEX SDMS for scientific data, data and instrument integration, and SAP and ERP integration set up during implementation.
LIMS Guides
Choosing and Running a LIMS
Plain-language guides for labs evaluating or extending a LIMS. See all articles.
LIMS
LIMS vs ELN vs SDMS: What Each One Does
A plain guide to what each lab system does, where they overlap and which your lab needs.
LIMS
SAP vs LIMS in Pharma: Can SAP QM Replace a LIMS?
Sample tracking, instrument integration, stability testing and compliance compared.
Stability
ICH Q1A Stability Testing: What Inspectors Check
Storage conditions, pull-date scheduling, trending and shelf life under ICH Q1A(R2).
Data integrity
ALCOA+ Data Integrity and GxP Compliance
Audit trails, electronic signatures and automated controls for GxP environments.
See a Sample Go From Request to Certificate
Book a demo and we will walk one sample through registration, testing, review, an OOS investigation and its Certificate of Analysis with you.
Request a LIMS DemoFrequently Asked Questions About LIMS Software
What is a LIMS (Laboratory Information Management System)?
A LIMS is software that manages laboratory data, samples, workflows, and instruments. It automates quality control processes, ensures data integrity, and helps laboratories comply with FDA 21 CFR Part 11, ISO 17025, and GMP regulations.
What industries use LIMS software?
LIMS software is used in pharmaceutical, food and beverage, chemical, environmental, water treatment, biotechnology, and clinical laboratories. Any lab requiring sample tracking, data integrity, and regulatory compliance benefits from LIMS.
Is CORPEX LIMS FDA 21 CFR Part 11 compliant?
Yes. Every CORPEX LIMS module (Samples & QC testing, Stability, Water, Microbiology & EM, ELN/LES worksheets) is designed for FDA 21 CFR Part 11 compliance, with electronic signatures that record name, time and meaning, a hash-chained tamper-evident audit trail, and data integrity controls.
What is the difference between LIMS and ELN?
LIMS focuses on sample management, testing workflows, and quality control data. An ELN (Electronic Lab Notebook) records experimental procedures and observations. CORPEX LIMS covers both: the ELN is part of CORPEX LIMS, so experiment records and routine sample testing live in one system.
Can LIMS integrate with laboratory instruments?
Yes. CORPEX LIMS supports direct instrument interfacing for automated data acquisition, eliminating manual transcription errors and ensuring data integrity in regulated environments.
Can CORPEX LIMS integrate with ERP systems like SAP?
Yes. CORPEX LIMS connects to SAP or any ERP through a configurable, API-key-secured interface: master data comes in, and results and documents go out. The interface is set up during implementation, and the CORPEX services team delivers SAP and ERP integration projects. See LIMS and SAP integration for detail.