LIMS
Sample lifecycle, test methods, instrument results, specifications, CoAs and review-and-approve flows for QC and clinical labs.
GxP software & validation · India
GxP software, built validation-ready.
LIMS, pharmacovigilance and quality workflows for pharma, biotech and laboratories — engineered with audit trails and e-signatures, and delivered with the documents your QA needs.
- FrameworkGAMP 5 · risk-based
- RegulationsPart 11 · Annex 11
- Data integrityALCOA+
- Sign-offYour QA
Bright Infonet develops GxP software in India, including LIMS, pharmacovigilance and QMS or document workflows, following a GAMP 5 risk-based approach. Systems support 21 CFR Part 11 and EU Annex 11 controls such as audit trails, e-signatures and ALCOA+ data integrity, and ship with a validation pack from URS to VSR. Your QA approves validation.
Regulated software has to do two jobs: support the lab or safety team’s work, and prove that it does so reliably. We design for the second from the start — audit trails, electronic signatures, access control and data integrity are part of the data model, not a later add-on.
We have built in this space ourselves: PVgenix, a pharmacovigilance SaaS with AI-assisted case intake, and a LIMS for NABL and ISO 15189 accredited labs and pharma QC. That experience shapes how we write requirements, trace them and test them.
We prepare the validation deliverables and execute testing with your team, but validation decisions and sign-off stay with your Quality Assurance function. That division is how GxP responsibility is meant to work, and we make it explicit in every project plan.
What we build
Systems for labs, safety and quality.
Pharmacovigilance
Case intake, triage, coding, assessment and submission workflows — the domain behind our PVgenix product.
QMS workflows
Deviations, CAPA, change control and training records with routing, due dates and trend reports.
Document control
Authoring, review, approval, versioning and periodic review of SOPs with controlled distribution.
Integrations
Instrument, ERP and safety-database interfaces with checks so data is not altered in transit.
AI with oversight
AI-assisted intake or data extraction where every suggestion is reviewed and confirmed by a qualified person.
Validation pack
From URS to VSR.
URS & validation plan
User requirements written with your process owners, and a plan setting scope, roles and approach.
Risk assessment
GAMP 5 categorisation and function-level risk assessment to focus testing where patient and data risk is highest.
Functional & design specs
How the system meets each requirement, including audit trail, e-signature and access-control design.
Traceability matrix
Every requirement traced to its specification and test, so gaps are visible before an auditor finds them.
IQ / OQ / PQ evidence
Test protocols, executed scripts, screenshots and deviations recorded to good documentation practice.
Validation summary report
A VSR drafted for your QA to review, approve and release — the decision remains theirs.
Is this for you?
A good fit if…
- You are a pharma, biotech, CRO or lab team replacing paper, spreadsheets or an unsupported system.
- You need software built with Part 11 and Annex 11 controls from the start, not retrofitted.
- Your QA team wants a complete, traceable validation pack rather than a demo and a user manual.
- You want a development partner who understands where their role ends and QA’s begins.
FAQ
Common questions.
Is your software 21 CFR Part 11 compliant?
Software alone cannot be Part 11 compliant; compliance comes from the system plus your procedures and validation. We build the technical controls — audit trails, e-signatures, access control, record retention — and document them for your QA.
Do you sign off validation for us?
No. We prepare the deliverables and help execute testing, but approval of the validation plan, protocols and summary report stays with your Quality Assurance team.
What is included in your validation pack?
Typically a validation plan, URS, risk assessment, functional and design specifications, traceability matrix, IQ/OQ/PQ protocols with executed evidence, and a draft validation summary report.
Do you follow GAMP 5 and computer software assurance?
Yes. We use GAMP 5’s risk-based approach and apply the critical-thinking principles of FDA’s Computer Software Assurance guidance to focus effort on high-risk functions.
Can GxP software run in the cloud?
Yes, with a qualified hosting setup, supplier assessment, backup and restore testing and clear responsibilities between you, us and the cloud provider.
What does ALCOA+ mean for the software?
Records must be attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available. We enforce this through user identity, timestamps, audit trails and controlled retention.
Keep reading
Related pages.
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