SilverLIMS™ — QC LIMS Software
Quality control LIMS for pharmaceutical labs: sample management, statistical process control, and OOS/OOT investigations in one system.
What SilverLIMS Is Built to Do
SilverLIMS is CORPEX's QC LIMS for pharmaceutical manufacturers: an integrated platform for managing raw materials, in-process items, and finished goods through the production process, from material registration to final product release.
It organizes the QC laboratory's core activities, including methods of analysis, certificates of analysis, product specifications, and statistical process control, and is designed to compliance standards including FDA, WHO GMP, ISO, and 21 CFR Part 11. It's built for the QC manager who has to answer, on demand, exactly which instrument produced a given result and who reviewed it.
Who Uses a QC LIMS Like SilverLIMS
Any pharmaceutical, food, or chemical QC lab running the same panel of tests against specification, batch after batch, is the intended user: raw-material testing before goods reach the line, in-process checks during manufacturing, and finished-product release testing before a batch can ship. SilverLIMS captures, organizes, and manages that test-execution workflow across the lab, letting staff track the sample lifecycle, run the lab's calculations, interface instruments, and keep the security and audit trail a QC release decision depends on.
Samples Management
The main function of a LIMS is managing sample receiving, distribution, tracking, and reporting. SilverLIMS also manages the resources around the sample: instruments, materials, product specifications, suppliers, reagents, and consumption.
- Sample login and tracking
- Resource management
- Barcode and label generation
- Chain of custody
Data Acquisition
A modern QC lab generates a lot of instrument output. SilverLIMS automates data acquisition so that the number stored against a sample is the number the instrument produced, not a value re-typed from a printout.
Direct instrument integration cuts out the manual transcription errors that a 21 CFR Part 11 or GMP audit is specifically designed to catch, and it protects the data integrity a lab's reputation and its release decisions both depend on.
The Compliance Requirement Behind QC Release
Why a QC lab can't run this on spreadsheets alone.
FDA 21 CFR Part 11 requires that electronic records used to support a batch release be as trustworthy as paper: every entry needs a timestamp, every change needs a documented reason, and every electronic signature has to tie back to one specific, authenticated person, not a shared login. WHO GMP and EDA GMP expectations layer on top of that: raw data has to be retained, and the record has to make it possible to reconstruct exactly how a batch was tested.
SilverLIMS's audit trail is built around that requirement: every analytical data transaction is logged and visualized so a reviewer or inspector can verify who entered a result, when, and what happened to it afterward. The data-integrity discipline underneath is ALCOA+: attributable, legible, contemporaneous, original, and accurate, applied as a default rather than a manual check.
Analysis Calculations
Comprehensive calculation modules for the standard pharmacopoeial tests a QC lab runs every day.
Agreement by HPLC
Agreement by UV
Investigations, Trending, and Resource Control
What happens once a result comes back, and how the lab's own resources stay under control.
Process Capability
Digital trending for process changes and capability indices, so drift toward a specification limit shows up before it becomes an out-of-specification result.
Investigations
Out-of-specification (OOS) and out-of-trend (OOT) investigation reporting, with root cause analysis (RCA) and CAPA tracked inside the same record.
Audit Trail
A visualized audit trail interface to verify and track analytical data transaction history for regulatory compliance.
Consumables Management
SilverLIMS monitors consumable levels, reagent usage, and stock, so budget decisions are based on organized inventory data rather than a shelf count.
Assets Management
Lab equipment records cover calibration, maintenance, and performance monitoring for the instruments the lab's results depend on.
How a Batch Moves Through SilverLIMS
From material registration to a signed certificate of analysis.
Registration and specification check
A raw material, in-process sample, or finished-product batch is registered against its product specification. SilverLIMS already knows which method of analysis (SOP) and which acceptance criteria apply, because the specification is on file rather than looked up separately for each batch.
Testing and data capture
Assay, dissolution, disintegration, average weight, and microbiology results are entered or pulled in directly from instruments through data acquisition, using the calculation modules built into the system rather than a separate worksheet.
Review and investigation
A result that falls outside specification triggers an OOS or OOT investigation, with root cause analysis and CAPA recorded against the batch rather than filed separately from the data that triggered it.
Release and certificate
Once results are reviewed and electronically signed, SilverLIMS generates the certificate of analysis from the underlying data, so the COA a customer or auditor sees traces directly back to the audit trail behind it.
What SilverLIMS Documents and Reports
The paperwork a pharmaceutical QC lab has to produce, generated from the same data.
SilverLIMS organizes the documentation a pharmaceutical QC lab is expected to maintain: methods of analysis (SOPs), certificates of analysis for finished products, bulk, raw, and packaging materials, and the product specifications those certificates are tested against. Standard materials and laboratory instruments used in testing are tracked alongside the results they produced, so a reviewer can confirm which reference standard and which calibrated instrument were behind a given number.
Annual Product Review (APR) draws on the same accumulated batch data, rather than being assembled from scratch once a year. Because the underlying records already carry an audit trail and electronic signatures, an APR built from SilverLIMS data holds up to the same scrutiny as the individual batch records it summarizes.
SilverLIMS for Egyptian Pharma QC Labs
Local support, and how SilverLIMS connects to the rest of the lab.
CORPEX is an Egyptian company, and SilverLIMS is implemented and supported in Arabic and English for Egyptian pharmaceutical QC labs working toward Egyptian Drug Authority (EDA) GMP expectations or EGAC accreditation under ISO/IEC 17025. See LIMS software in Egypt and mapping a LIMS to ISO 17025 for the local detail.
SilverLIMS is one product in the wider CORPEX LIMS family: a lab also running microbiology testing pairs it with MicroLIMS, and a lab running stability programs pairs it with Stability LIMS Software. Because deploying SilverLIMS is itself a computerized system change, every implementation is backed by computer system validation (CSV) so the system is inspection-ready at go-live.
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Contact us today to learn more about SilverLIMS.
Contact UsFrequently Asked Questions About SilverLIMS
What makes SilverLIMS a QC LIMS rather than a general LIMS?
SilverLIMS is built around the workflow a QC laboratory actually runs: raw-material, in-process, and finished-product testing against a specification, with certificates of analysis and statistical process control as standard outputs, rather than a generic sample tracker adapted after the fact.
How does SilverLIMS handle out-of-specification (OOS) results?
An OOS or OOT result opens an investigation record inside SilverLIMS, with root cause analysis and CAPA tracked against it, instead of the investigation living in a separate document outside the system that generated the result.
Is SilverLIMS 21 CFR Part 11 compliant?
Yes. SilverLIMS is designed for FDA 21 CFR Part 11 compliance, with electronic signatures tied to individual user accounts, a visualized audit trail of every analytical data transaction, and controls aligned to ALCOA+ data integrity.
Can SilverLIMS interface directly with lab instruments?
Yes. SilverLIMS supports direct instrument data acquisition, so results are captured from the instrument rather than re-typed from a printout, which removes a common source of transcription error in QC labs.
Does SilverLIMS track lab consumables and equipment calibration?
Yes. SilverLIMS includes consumables management for reagent usage and stock levels, and assets management for instrument calibration and maintenance records.
Is SilverLIMS available with Arabic support in Egypt?
Yes. CORPEX is an Egyptian company, and SilverLIMS implementation, training, and support are available in Arabic and English for labs working toward EDA GMP or EGAC ISO/IEC 17025 accreditation.