QC & R&D laboratories
LIMS for sample login, test methods, specifications, stability pulls, OOS handling and certificates of analysis.
Industries · Pharma & life sciences
Pharma software that holds up in an inspection.
Quality, safety and laboratory systems for pharma manufacturers, biotech companies and CROs — with the audit trail, e-signatures and validation evidence designed in.
- SystemsLIMS · PV · QMS
- RegulationsPart 11 · Annex 11
- ValidationGAMP 5 · CSA
- Sign-offYour QA team
Bright Infonet is a Panchkula-based software company that builds software for pharma and life-science teams: LIMS for QC and R&D labs, pharmacovigilance systems, QMS workflows such as deviations and CAPA, and computer system validation. Every system is designed for 21 CFR Part 11 and EU Annex 11 controls, and your QA team keeps validation sign-off.
A pharma company rarely needs “an app”. It needs a set of systems that each carry regulatory weight: the QC lab records results that release batches, the safety team reports adverse events against legal deadlines, and quality assurance tracks every deviation to closure. This page is the map of how we help across those areas.
Each area has its own specialist page. LIMS covers samples, stability studies, instrument data and certificates of analysis. Pharmacovigilance covers case intake, MedDRA coding, E2B(R3) reporting and signals. Computer system validation covers proving that any GxP system — ours or a vendor’s — is fit for its intended use.
What ties them together is the same engineering discipline: requirements that trace to tests, controls for data integrity under ALCOA+, change control after go-live, and documents your QA can review. We have built PVgenix, a pharmacovigilance SaaS, and a LIMS for pharma QC and diagnostic labs, both described on our work page.
Where we help
Systems across the pharma value chain.
Drug safety
Pharmacovigilance case management from intake and triage to coding, assessment and regulatory submission.
Quality management
Deviations, CAPA, change control, complaints and training records routed with due dates and e-signatures.
Document control
SOP authoring, review, approval, effective dates and periodic review, with controlled versions only.
Validation of existing systems
CSV or CSA for systems you already run — commercial LIMS, ERP modules, QMS tools or GxP spreadsheets.
Data and reporting
Trend reports and dashboards for quality reviews, built on validated data rather than exported copies.
Built in, not bolted on
Controls inspectors ask about first.
Audit trail by design
Every GxP record keeps who, what, when and why, with old and new values that cannot be edited or switched off by users.
Electronic signatures
Signatures bound to the record with the signer’s name, date, time and meaning, as Part 11 describes.
Role and duty separation
Analysts, reviewers and approvers get different rights, and nobody approves their own work.
Traceable requirements
A traceability matrix links each user requirement to its design and test, so coverage gaps show early.
Change control after go-live
Releases go through impact assessment and regression testing so the validated state is kept.
Backup and restore tested
Retention, archive and restore procedures are tested, not assumed, before the system goes live.
Is this for you?
A good fit if…
- You are a pharma manufacturer, biotech company or CRO replacing paper logbooks, spreadsheets or an unsupported system.
- You need more than one regulated system and want one partner who understands how they connect.
- Your QA team wants requirements, risk assessments and test evidence, not just a working demo.
- You have a vendor system in place and need it validated or brought back into a validated state.
FAQ
Common questions.
What software does a pharma company need?
Most need a LIMS for QC testing, a pharmacovigilance system for adverse events, QMS workflows for deviations, CAPA and change control, and document control for SOPs. Which to build, buy or validate first depends on your current gaps and inspection findings.
Should we build custom pharma software or buy a commercial product?
Buy when a product fits your process with configuration only; build when your workflows are unusual or packaged tools need heavy workarounds. Either way the system must be validated, and we can do that for both.
Do you work with Indian pharma companies exporting to the US and EU?
Yes. We design for 21 CFR Part 11 and EU Annex 11 together, because export-oriented sites are inspected against both, and we work with teams anywhere in India and abroad.
Who is responsible for compliance, you or us?
We build the technical controls and prepare validation documents. Compliance also depends on your procedures, training and QA decisions, so approval of the validated state stays with your Quality Assurance team.
Can different systems share data, for example LIMS and ERP?
Yes. We design interfaces with checks so data is not altered in transit, and include them in the validation scope so the integration is tested like the rest of the system.
How does a pharma software project usually start?
With a short discovery: we review your process, current systems and recent audit observations, then agree the first system to tackle and the validation approach in writing.
Keep reading
Related pages.
Have a project in mind?Talk to an engineer →