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Loved by 162+ pharmaceutical companies

Pharmaceutical Software Development for GxP Teams Still Running on Paper

For pharma and biotech quality, manufacturing, and lab operations teams: paper logs and controlled spreadsheets rebuilt as audit-trailed apps. From $1,350.

How your project runs

01 · Free
page.jsx123456TERMINAL$ npm run buildCompiled successfullyyourapp.comLive
  1. 01Free Process Review
  2. 02Requirements and Risk
  3. 03Traceable Build
  4. 04Validation Support
  5. 05Release and Support

Industry leaders we work with

  • .NET
  • Node.js
  • React
  • TypeScript
  • PostgreSQL
  • Audit trail service
  • E-signature service
  • Role-based access
  • PDF record templates
  • ERP API
  • QMS connector
  • LIMS exports
  • SFTP
  • SAML and OIDC SSO
  • AWS
  • Microsoft Azure

The Problem

Your GxP Records Live in Binders and Spreadsheets Nobody Trusts

It shows during inspections and batch release. Your ERP, QMS, and LIMS cover the big processes, while logbooks, cleaning records, and review checklists still run on paper and locked spreadsheets.

  1. Paper logbooks

    Equipment and cleaning entries go missing dates or signatures.

    Paper logbooks

    Electronic logbooks require each field and stamp the user and time themselves.

  2. Spreadsheet limits

    Anyone with access can still change a controlled spreadsheet formula.

    Spreadsheet limits

    Calculations move into code, with every change versioned, reviewed, and logged.

  3. Late deviations

    Deviations start as emails and reach the QMS days later.

    Late deviations

    An intake form captures the event on the floor and posts it to your QMS.

  4. Validation scramble

    QA reverse-engineers the system after it's already built.

    Validation scramble

    A traceability matrix links each requirement to its test from the first sprint.

A batch is ready for release, and QA is flipping through a paper equipment logbook to check a cleaning entry. One signature has no date. The cleaning schedule lives in a controlled spreadsheet that anyone with the file can still edit, and its version history shows nothing useful. Deviations start as emails and reach the QMS days later. When an inspector asks who changed a limit and why, your team spends the afternoon rebuilding the story from printouts.

We start with your process map and the records each step must produce. Then we build small, focused apps for those steps: electronic logbooks, review checklists, and intake forms that feed your QMS. Each record carries a computer-generated audit trail, and signatures show name, date, time, and meaning, as 21 CFR Part 11 describes. Your validation team tests from our traceability matrix instead of reverse-engineering the system after launch.

  • Audit trails on every record

    Every entry, change, and signature is time-stamped by the system and kept with the record it touched.

  • Traceability from day one

    Each user requirement maps to a design note and a test, so validation follows the build.

  • Fits beside ERP, QMS, and LIMS

    We fill the gaps between your validated systems instead of replacing any of them.

Our Pharmaceutical Software Development Process

From Process Map to Validated Release in Five Clear Steps

You approve the user requirements and risk assessment before design and review working screens every sprint. Your QA team executes the validation tests before anything goes live.

  1. We walk through the paper or spreadsheet process with your quality and operations leads and mark which records are GxP. You get a short gap list, the risk level of each step, and a written scope.

Projects We've Built

LifePulse, Carepoint, MediPulse, and HealCon are healthcare apps and dashboards we designed and built. They show our records and workflow work, not GxP-validated pharma systems.

What's Included

What You Get With Custom Pharmaceutical Software Design and Build

Your project covers the app, its audit trail and signatures, and links to the systems you already validated. You also get the documents your QA team needs to validate it.

  • Electronic logbooks and forms

    Your equipment, cleaning, and room logs with required fields, so no entry saves without a date and a signer.

  • Audit trail and e-signatures

    System-generated audit trails, plus signatures that record printed name, date, time, and meaning on every signed record.

  • Links to ERP, QMS, and LIMS

    Batch numbers, materials, and deviations exchanged with your validated systems through their APIs or exports.

  • Review-by-exception checklists

    Batch record and logbook review screens that show reviewers only the entries that need a second look.

  • Validation document set

    User requirements, risk assessment, traceability matrix, and draft test scripts in your quality system's format.

  • Training and handover

    User guides, admin runbooks, and the full source code, with change control notes for future releases.

Compare Options

DeveloperLook vs Packaged Suite vs Controlled Spreadsheets

Packaged pharma software companies cover common processes well, and a controlled spreadsheet is fine for low-risk records. Here is where each option fits and where custom work pays off.

DeveloperLook
Packaged suite
Fit to your process
DeveloperLook: Built around your SOPsPackaged suite: SOPs change to fit the suite
Audit trail
DeveloperLook: System-generated on every recordPackaged suite:
Electronic signatures
DeveloperLook: Name, date, time, and meaningPackaged suite:
Validation effort
DeveloperLook: Traceability matrix from the buildPackaged suite: Vendor package plus your tests
Time to go live
DeveloperLook: 7 to 17 weeksPackaged suite: Months of configuration
Upfront cost
DeveloperLook: Fixed price per phasePackaged suite: License plus implementation
Ongoing fees
DeveloperLook: No license feesPackaged suite: Annual subscription per user
Code ownership
DeveloperLook: You own the codePackaged suite: Vendor owns the code

What Our Clients Say

What Clients Say After Launch

Feedback from teams we have built healthcare apps, dashboards, and internal tools for.

We had a pretty specific idea of what we wanted our website to become, but I wasn’t sure how easily we could explain all of it to a development team. There were quite a few moving parts, and we were working toward a deadline, so I expected a few things to get lost along the way. That never really happened. They understood what we were trying to achieve, kept us updated throughout the process, and got everything ready within the agreed timeline. The final site feels much easier to navigate, works beautifully on mobile, and is noticeably smoother for our customers. It was a huge relief seeing the original idea actually turn into the website we had in mind.

Michael BennettFounder & CEO of Northbridge Consulting01 / 03
  • 1,250+

    Projects shipped

  • 10+

    Years of experience

  • 5 stars

    Clutch rating

  • 5 stars

    GoodFirms rating

  • Excellent

    Trustpilot rating

  • Top 3%

    Upwork Top Rated Plus

  • 1,250+

    Projects shipped

  • 10+

    Years of experience

  • 5 stars

    Clutch rating

  • 5 stars

    GoodFirms rating

  • Excellent

    Trustpilot rating

  • Top 3%

    Upwork Top Rated Plus

Want results like these?

Tell us what you are building. You get a reply within 24 hours on business days, then a written estimate.

Work Culture

Why Pharma Quality Teams Trust Us With GxP Software

Your records end up in front of inspectors, and your QA team signs the validation. These habits keep our work easy to validate, change, and defend.

  • Requirements before screens

    We write user requirements with you before design starts. Your QA team validates against a document they approved, not against whatever got built.

  • Traceability kept as we build

    Each of your requirements links to its design note and test in a matrix we update every sprint. Your validation starts from a complete map instead of a scramble.

  • Validation decisions stay yours

    We supply evidence and fix defects, and your quality unit decides what is validated and released. We don't sign off GxP compliance on your behalf.

  • Changes through change control

    After release, every change you request ships with a change note, an impact assessment, and regression tests. Your change control board approves it before it reaches production.

  • Honest about packaged suites

    If a packaged module or a controlled spreadsheet already covers the process, we'll tell you before we quote. Custom software only earns its validation cost where neither fits.

  • Your code and documents

    Source code, validation documents, and cloud accounts belong to you from day one. Your inspectors and future vendors can read everything without asking us.

Overview

What does pharmaceutical software development cover for GxP teams?

DeveloperLook provides pharmaceutical software development for quality, manufacturing, and lab operations teams. We build electronic logbooks, review-by-exception checklists, deviation intake, and links to your ERP, QMS, and LIMS, with audit trails and a traceability matrix. Projects start at $1,350 and take 7 to 17 weeks, including support for your validation tests.

DEVELOPERLOOK

Project facts · Pharmaceutical Software Development

Service
Pharmaceutical Software Development (electronic logbooks, review checklists, system links, validation documents)
Typical timeline
7 to 17 weeks, including validation support
Platforms
Your ERP, QMS, LIMS, and single sign-on directory
Built with
.NET or Node.js, React, PostgreSQL, and AWS or Azure
Experience
10+ years of development experience and 1,250+ shipped projects
Post-launch support
60 days of post-launch support
Communication
Calls in US, UK, and AU business hours
Starting price
From $1,350 USD, fixed scope after a free process review

Reviewed 28 Oct 2026 by Saimul Islam

Good fit

  • QA teams buried in paper logbooks

    Your QA reviewers spend batch release checking paper logbook entries, and you want electronic records with required fields and a reliable audit trail.

  • Sites with controlled spreadsheets

    Your site runs cleaning schedules and calculations in controlled spreadsheets, and the last inspection asked how you control formula changes.

  • Biotechs growing into GMP

    You're moving from development into clinical manufacturing and need pharma industry software sized for a small team, not an enterprise suite.

  • IT leads comparing pharma software solutions

    You're comparing pharma software solutions for one process, and you want a straight answer on whether to configure a suite or build.

  • Agencies with a life sciences client

    Your agency handles a drug maker's digital work, and the client now needs custom software development for pharmaceutical quality teams.

Not a fit

  • Full LIMS for your lab

    You need sample tracking, test assignment, and certificates of analysis for a whole lab. Our LIMS Development page covers that system.

  • Clinical trial systems

    You need study operations, site tracking, or trial data capture. Our Clinical Trial Software Development page covers those builds.

  • Software inside a device

    Your code runs inside or alongside a medical device under IEC 62304. Our Medical Device Software Development page fits better.

  • Budget under $1,350

    Your budget is under $1,350, or a controlled spreadsheet already meets the risk. If it does, we'll tell you before we quote.

Not sure we're the right fit?

Book a free call or message us. We'll tell you honestly whether we're the right team.

Pricing

Transparent Starting Prices for Pharmaceutical Software Development

These are starting points in USD. Your final price depends on the number of records, integrations, and risk level, and you get a fixed proposal after a free process review.

$2k$4k$6k$8k$10k$1,350$4,100$8,700

For sites replacing one paper logbook or controlled spreadsheet with an audit-trailed app.

$1,350one-time, USD

Get a fixed quote
  • One electronic logbook or form
  • System-generated audit trail
  • Electronic signatures with name and meaning
  • Role-based access with single sign-on
  • User requirements and traceability matrix
  • 60 days of post-launch support

Recommended

For quality teams moving review, deviations, and logbooks into one audited workflow.

$4,100one-time, USD

Get a fixed quote
  • Everything in Single Logbook
  • Up to 4 logbooks or forms
  • Review-by-exception checklists
  • Deviation intake posted to your QMS
  • Draft validation test scripts

For sites linking many GxP records to their ERP, QMS, and LIMS, with reporting.

$8,700one-time, USD

Get a fixed quote
  • Everything in Quality Workflow
  • Up to 10 logbooks, forms, or checklists
  • Links to ERP, QMS, and LIMS
  • Trend reports for QA and management
  • Risk assessment and release documents

For Agencies

White-Label Pharma Software Development for Agencies and Studios

You own the client relationship. We supply the GxP-aware engineering behind the apps your life sciences clients ask for, delivered under your brand. Every build comes with requirements, traceability, and test scripts their QA team can use.

How the partnership works

White label: your client only ever sees your brand

Your clientSees only your brand
You, the agencyOwn the relationship
DeveloperLookBehind your brand
  1. Share the brief

    Send the client's process, systems, and quality procedures, and we shape the scope.

    • Client needs
    • You share the details
    • Details received
  2. We propose and staff

    You get a fixed proposal in your agency's name and a named team.

    • Scope and plan
    • Proposal to resell
    • Your quoteYOUR LOGO
  3. Build and hand off

    We build, support validation, and hand over the code and documents.

    • Done by our team
    • Your brand on it
    • Handed to your clientDone
  • Your client
  • You, the agency
  • DeveloperLook
  1. Share the brief

    Send the client's process, systems, and quality procedures, and we shape the scope.

    1. Client needs
    2. You share the details
    3. Details received
  2. We propose and staff

    You get a fixed proposal in your agency's name and a named team.

    1. Scope and plan
    2. Proposal to resell
    3. Your quoteYOUR LOGO
  3. Build and hand off

    We build, support validation, and hand over the code and documents.

    1. Done by our team
    2. Your brand on it
    3. Handed to your clientDone
  • Stay client-facing

    Your agency leads the pharma client while we build behind the scenes.

  • Validation-ready output

    Requirements, traceability, and draft test scripts in your client's own format.

  • Senior GxP engineers

    Engineers who design audit trails, signatures, and access rules into the build.

  • Flexible capacity

    Add regulated-software engineers for one client project without hiring anyone.

The Right Technology for Your Project

Technology Stack

We build on mainstream stacks your IT team can support and keep the audit trail and signature logic in the backend, where users can't bypass it.

    • .NET logo.NET
    • Node.js logoNode.js
    • React logoReact
    • TypeScript logoTypeScript
    • PostgreSQL logoPostgreSQL
    • Audit trail service
    • E-signature service
    • Role-based access
    • PDF record templates
    • ERP API
    • QMS connector
    • LIMS exports
    • SFTP
    • SAML and OIDC SSO
    • AWS logoAWS
    • Microsoft Azure logoMicrosoft Azure
    • Docker logoDocker
    • Jest
    • Test script library
01 / 04

FAQ

Frequently Asked Questions

Straight answers on cost, timelines, Part 11, validation, AI rules, and data management in pharma.

  • Pharmaceutical software development at DeveloperLook starts at $1,350 for one electronic logbook or form with an audit trail, signatures, and a traceability matrix. A quality workflow with up to 4 records, review-by-exception, and deviation intake starts at $4,100. A site operations suite with up to 10 records and ERP, QMS, and LIMS links starts at $8,700. You get a fixed quote after a free process review.

  • Most projects take 7 to 17 weeks from process review to release. A single logbook takes about 7 to 9 weeks, and a quality workflow about 11 to 13. A site operations suite runs up to 17 weeks. Your team's validation testing sits inside that window, and quick test execution is what keeps it short.

  • LIMS software in pharma is the laboratory information management system that tracks samples, tests, results, and approvals in QC and R&D labs. It holds your release and stability testing data and produces your certificates of analysis. This page covers the records around the lab, and our LIMS Development page covers the LIMS itself.

  • There's no single best tool: the right one depends on which records you manage and how much risk they carry. Your ERP, QMS, and LIMS suites cover the core processes. For the records between them, a small custom app with an audit trail often serves you better than one more module. Ask every vendor to show audit trails and access controls working on your own data.

  • It means your AI feature is a computerized system like any other: you define and validate its intended use, risks, data, and controls. FDA issued draft guidance in January 2025 on AI used to support regulatory decisions for drugs and biologics. We keep AI suggestions behind your human reviewer, log every output, and record the model version.

  • We build the technical controls Part 11 describes, but compliance depends on how your company validates and uses the system. Those controls include secure, time-stamped audit trails, signatures that show name, date, time, and meaning, and access checks. Your QA team validates the system and owns the procedures around it.

  • No, your quality unit validates it, and we support every step. We follow the risk-based approach in ISPE's GAMP 5 Second Edition: requirements, risk assessment, and testing scaled to each function's risk. You get the traceability matrix and draft test scripts, your team executes them, and we fix any defect they find.

  • Pharma software companies sell configurable suites for common processes such as QMS, LIMS, and ERP. A suite gives you a vendor validation package and an annual license. A custom build fits the processes those suites leave on paper, at a fixed price and with code you own. You may well use both side by side.

  • Processes with clear records and steady SOPs suit custom software best. Think equipment and cleaning logbooks, room status boards, sample pull schedules, and batch record review checklists. Your best candidates already run on paper or controlled spreadsheets. Processes your QMS or ERP already handles well should stay where they are.

  • You do. Source code, validation documents, and cloud accounts sit in your accounts from day one, so inspectors and future vendors can read them. After release you get 60 days of post-launch support. Later changes run through your change control, each with an impact note and regression tests.

Saimul IslamFounder & CEO, DeveloperLook

Still have questions?

Send a message or book a call with the team.

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