Sample lifecycle
Login, labelling, receipt, allocation, testing, review, approval, retention and disposal with status at every step.
Regulated software · LIMS
A LIMS built around your lab, not the other way round.
Laboratory information management for pharma QC, R&D and stability labs — samples, methods, instruments and certificates in one validated system.
- LabsQC · R&D · Stability
- RecordsPart 11 · Annex 11
- ValidationGAMP 5 pack
- OutputSigned CoA
Bright Infonet is a Panchkula-based software company that builds LIMS and pharmacovigilance software for 21 CFR Part 11, validated with a GAMP 5 approach. Our custom LIMS covers the full sample lifecycle, stability studies, instrument integration and certificates of analysis, with audit trails, e-signatures and a validation pack delivered alongside the code.
Off-the-shelf LIMS products are built for an average lab. Many QC and R&D labs end up configuring around them for months, or keep critical steps on paper because the product does not fit. A custom LIMS starts from your methods, specifications and approval chain instead, and models them directly.
We build the LIMS around the life of a sample: login against a specification, allocation to analysts and instruments, result entry or capture, calculations, review, approval and the certificate of analysis. Stability studies add protocols, storage conditions and pull schedules; out-of-specification results open an investigation rather than being overwritten.
The validation work runs in parallel. URS, risk assessment, design specifications, traceability matrix and IQ/OQ/PQ protocols are written by the people building the system, and your QA reviews and approves them. We have built a LIMS for pharma QC and NABL diagnostic labs, described on our work page.
What the LIMS covers
Every step a sample goes through.
Specifications & methods
Versioned specifications, test methods and limits, so results are always checked against the approved version.
Stability studies
Protocols, storage conditions, pull schedules and trend charts across time points and batches.
Instrument integration
Results captured from instruments, chromatography data systems or exported files, with the raw data linked.
OOS & investigations
Out-of-specification and out-of-trend results trigger a tracked investigation instead of a silent retest.
Certificate of analysis
CoAs generated from approved results only, signed electronically and released to the right customer or batch.
Part 11 controls
Data integrity your QA can demonstrate.
Secure audit trail
Each result, sample status and specification edit is logged automatically with user, timestamp and a mandatory reason.
Electronic signatures
Review and approval signatures linked to the record, with the meaning of each signature shown.
Access by role
Analyst, reviewer, approver and administrator rights kept separate, with periodic access reviews supported.
Calculations under control
Formulas defined and verified in the system, not in uncontrolled spreadsheets beside it.
Reagents & standards
Lots, expiry dates and preparation records linked to the tests that used them.
Validation pack
URS, risk assessment, specifications, traceability matrix, IQ/OQ/PQ protocols and a draft summary report.
Is this for you?
A good fit if…
- Your QC or R&D lab still runs on paper logbooks, Excel and manual CoAs.
- A commercial LIMS was quoted but needs too much configuration or too many workarounds for your methods.
- Stability studies are tracked in spreadsheets and pull dates get missed.
- Your QA wants the validation documents written alongside the system, not after it.
FAQ
Common questions.
What is a LIMS used for in pharma?
A laboratory information management system tracks samples, tests, results and approvals in QC and R&D labs. In pharma it also provides the audit trail, e-signatures and certificates of analysis that regulators expect.
Is a custom LIMS better than an off-the-shelf LIMS?
Not always. Off-the-shelf suits labs whose workflow matches the product; custom suits labs with unusual methods, integrations or approval chains. We give an honest recommendation after looking at your process.
Can the LIMS meet 21 CFR Part 11?
The LIMS provides the controls Part 11 describes for lab records, such as secure audit trails, signature manifestation and unique user logins. Whether your use of it complies also depends on your SOPs, training and validation, which your QA approves.
Which instruments can you integrate with the LIMS?
It depends on what each instrument or data system can output, such as files, a database or an interface. We confirm the method for each instrument during discovery.
How long does it take to build and validate a LIMS?
It depends on the number of labs, modules and instruments. We usually deliver in phases, starting with the sample lifecycle and CoA, and agree the timeline in writing after discovery.
Do you provide the GAMP 5 validation documents?
Yes. We prepare the URS, risk assessment, specifications, traceability matrix, IQ/OQ/PQ protocols and a draft validation summary report. Your QA reviews, executes where required and signs off.
Keep reading
Related pages.
Have a project in mind?Talk to an engineer →