What pharmaceutical software development covers
Aranv provides pharmaceutical software development for emerging pharma and biotech companies, contract testing labs and drug distributors in the US: lab and quality apps, document control, LIMS and ERP integrations, supply chain data exchange and AI that searches and drafts regulated documents, with review and validation steps agreed with your quality team.
Pharmaceutical software is judged by its records as much as its screens. When records that FDA rules require are kept electronically, 21 CFR Part 11 shapes audit trails, electronic signatures, access control and validation. We design for those points with your quality assurance lead from the first workshop, and your QA team makes the validation decision using the evidence we produce.
The Drug Supply Chain Security Act calls for electronic, interoperable tracing of certain prescription drugs at the package level between manufacturers, repackagers, wholesale distributors and dispensers. We connect ERPs and warehouse systems to the serialization or EPCIS service you use through API integration, and check FDA’s DSCSA pages for current compliance policies.
How a regulated lab record moves through connected systems
Sample to signed result
- 01 Register the sample Intake captures source, lot and chain of custody from a scanned label.
- 02 Capture instrument results Instrument output flows into the LIMS without retyping values.
- 03 Review and sign A second analyst reviews, and an electronic signature locks the record.
- 04 Report and trend Certificates of analysis and trend charts come from the signed data.
Audit trails, roles and validation evidence are agreed with your quality lead before the build starts.
Life sciences software and lab tools
Smaller life sciences companies often run regulated work through spreadsheets, shared drives and paper logbooks beside a validated system or two. These builds close the gaps.
Lab apps and LIMS links
Sample intake, chain of custody, test assignments and instrument results connected to your LIMS or ELN, so analysts stop copying values by hand.
Quality and document control
SOPs, deviations, CAPAs and change controls routed for review and electronic signature, with an audit trail on every edit.
Supply chain data exchange
Transaction data and product identifiers exchanged with trading partners through your serialization or EPCIS provider, with exceptions routed to staff.
AI for regulated documents
Search across approved SOPs and study reports, first drafts of summaries and triage of incoming safety reports, each checked by a qualified reviewer.
Validation-ready software delivery
Regulated teams need evidence as much as features. We trace every requirement to its tests, keep executed test records with screenshots and write release notes your change control can use.
What we do
- User requirements traced to tests
- Executed test scripts with evidence
- Audit trail and e-signature design
- Release notes for change control
- Periodic access review reports
AI with quality review built in
An assistant that quotes an outdated SOP causes more trouble than it saves. We limit AI search to approved, current versions, show the source passage beside each answer and record which reviewer accepted or rejected the output.
What we do
- Search limited to approved versions
- Source passage beside every answer
- Reviewer sign-off before use
- Logged inputs and outputs
- Model and prompt version records
How we approach a project
Some projects, such as patient support programs, involve protected health information. In those cases HIPAA requirements shape hosting, access and the vendor agreements needed, and your compliance lead confirms them with us before any code is written. Our healthcare software page covers provider-side work.
AI fits the document-heavy side of the industry: finding the current SOP, comparing a new deviation with past ones, drafting a report section or sorting incoming safety reports. Our page on AI for pharma and life sciences describes these uses, and RAG development explains how answers stay tied to approved sources. A qualified person reviews every output that feeds a regulated decision.
We take on focused projects, such as one lab workflow, and plan larger systems in phases. Use our contact page to book, and bring a list of your lab and quality systems to the 30-minute conversation.
How we work
- Records that stand up to inspection
- Quality signs off before release
- AI drafts, qualified people decide
Our Process
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Agree the regulatory scope
With your QA lead we list which records are regulated, which rules apply and what validation evidence is needed.
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Write traceable requirements
Each user requirement gets an ID that later links to design notes, test cases and results.
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Build and test in documented cycles
Test scripts run against each release, with results, screenshots and defects recorded for your review.
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Release under your change control
Go-live follows your formal approval, and later changes pass through the same change control process.
Why life sciences teams choose Aranv
Quality team involved early
Your QA lead sees requirements and test plans before code is written, so validation is not a scramble at the end.
Honest about compliance
We describe what the software does and how it was tested, and we never label a system compliant on our own authority.
AI kept to approved sources
Assistants search only approved, current documents and show the passage they used, and every output waits for a qualified reviewer’s decision.
Data stays where you decide
Hosting region, access roles and AI vendor settings are chosen with your IT and QA teams and written into the design.
Planning Pharmaceutical Software Development?
Book a 30-minute conversation with the team that would build it.
Pharmaceutical software FAQs
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Can you build software that meets 21 CFR Part 11?
We build the controls Part 11 calls for, such as audit trails, unique logins, signatures linked to their records and documented testing. Whether a system complies depends on how your company validates and uses it, so your quality team makes that call using the requirements, test scripts and results we supply.
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Should we customize our LIMS or build separate lab software?
Configure the LIMS first if it supports the workflow, since every change to a validated system adds testing. Separate lab software suits client sample portals, instrument file parsers and dashboards, connected back through the LIMS API.
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Can we use AI on GxP documents?
Yes, as an assistant. AI can search approved documents, compare records and draft text, but it should not approve, release or sign anything. We restrict it to approved document versions, log inputs and outputs, and send every result to a qualified reviewer.
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What drives the cost of pharmaceutical software?
The validation evidence required, how many roles and screens you need, links to LIMS, ERP or serialization services, data migration from older systems and hosting requirements. After discovery we estimate in phases, with documentation effort shown separately so you can see what it adds.
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What if a project involves patient data under HIPAA?
Many lab, quality and supply chain systems hold no patient data at all. When a project does handle protected health information, HIPAA then governs where that data lives, who may view it and what each vendor must sign, and we settle those points with your compliance lead before work begins.
Let’s talk about your next step
Contact Aranv to discuss your workflow, current tools, and goals. Meet with our team or send an inquiry.
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Prefer email? sales@aranv.com