Audit trails
Secure, time-stamped records of every create, change and delete, with the old value, new value and reason.
Regulated software · GxP
Software built for the audit from day one.
LIMS, drug-safety and QA systems for pharma, QC and diagnostic labs — with audit trails, e-signatures and validation documents delivered alongside the code.
- ApproachGAMP 5, risk-based
- RecordsPart 11 · Annex 11
- IntegrityALCOA+
- Sign-offYour QA team
Bright Infonet develops GxP regulated software such as LIMS and pharmacovigilance systems. Audit trails, e-signatures, role-based access and record locking are built in to meet 21 CFR Part 11 and EU Annex 11 expectations, and we deliver a GAMP 5 validation pack from URS to summary report. Final validation sign-off stays with your QA team.
In regulated work, the software is only half the deliverable. Inspectors want evidence: who changed a record, when, why, and who approved it. We design those controls into the data model from the first sprint, rather than bolting them on before go-live.
Alongside the code we write the validation documents — URS, risk assessment, traceability matrix, IQ/OQ/PQ protocols and a summary report — following a risk-based GAMP 5 approach. Your QA team reviews, executes where required and signs off; approval of the validated state always stays with you.
We have built PVgenix, a pharmacovigilance SaaS, and a LIMS for NABL/ISO 15189 and pharma QC labs. We support companies across India and worldwide, including labs and pharma units around Panchkula, Mohali and Chandigarh.
What you get
Controls and evidence, delivered together.
Electronic signatures
Signatures linked to their records, with meaning, date and signer identity, per Part 11 expectations.
Access & record locking
Role-based permissions, segregation of duties and locking of approved records against edits.
Validation pack
URS, risk assessment, traceability matrix, IQ/OQ/PQ protocols and a validation summary report.
Change control
Documented releases with impact assessment, so updates don’t quietly break the validated state.
Instrument & data capture
Results captured from lab instruments and files, not retyped, to reduce transcription errors.
Systems we build
For work that has to pass inspection.
LIMS
Sample registration to signed report for NABL/ISO 15189 diagnostic labs and pharma QC labs.
Pharmacovigilance
Case intake, coding and regulatory reporting, with AI pre-reading each case, as in PVgenix.
QA & document workflows
Deviations, CAPA, SOP review and approvals with full history and e-signatures.
Validated web platforms
Custom GxP portals and tools built on the same stack as our other platforms, with validation added.
Legacy remediation
Gap assessment of an existing system and the fixes and documents to bring it into a validated state.
Paper-to-digital moves
Replace paper logbooks and spreadsheets with controlled electronic records.
Is this for you?
A good fit if…
- A pharma, QC or diagnostic lab is moving off paper and spreadsheets.
- Your system has to hold up in audits and regulatory inspections.
- An existing system needs to be assessed and brought into a validated state.
- You want the validation documents written by the people who built the software.
FAQ
Common questions.
What is GxP software development?
It is building software used in regulated life-science work, where records must be accurate, traceable and controlled, and the system must be validated for its intended use.
Is your software 21 CFR Part 11 compliant?
We build the technical controls Part 11 expects — audit trails, e-signatures, access control and record protection. Compliance also depends on your procedures and validation, which your QA team owns.
What is included in a GAMP 5 validation pack?
Typically a URS, risk assessment, traceability matrix, IQ/OQ/PQ protocols and a validation summary report, scaled to the system’s risk.
Who signs off software validation?
Your QA team. We prepare the documents and support execution, but approval of the validated state stays with the regulated company.
Can you build a custom LIMS for our lab?
Yes. We have built a LIMS for NABL/ISO 15189 diagnostic labs and pharma QC labs, and adapt workflows, instruments and reports to your lab.
Does EU Annex 11 differ from 21 CFR Part 11?
They overlap heavily on audit trails, signatures and data integrity. Annex 11 adds more emphasis on risk management, supplier oversight and periodic review; we design for both.
Keep reading
Related pages.
Have a project in mind?Talk to an engineer →