GlideApps / Agency

Compliance & Auditing

Build a FDA Compliance App with Glide

FDA compliance failures cost companies millions in recalls, warning letters, and consent decrees — and most failures are traceable to inadequate documentation and oversight systems. GlideApps Agency builds FDA compliance apps that help regulated companies maintain rigorous documentation, track deviations, manage CAPAs, and stay inspection-ready 365 days a year. We've built compliance systems for medical device, pharmaceutical, food, and cosmetics companies.

FDA Compliance app built with Glide
COCA-COLA+
AMERICAN EXPRESS+
GAF+
SOTHEBY'S+
MARGARITAVILLE+
MEDTRONIC+
DATAIKU+
ZAPIER+
WORK RIDE+
AGILENT+
COCA-COLA+
AMERICAN EXPRESS+
GAF+
SOTHEBY'S+
MARGARITAVILLE+
MEDTRONIC+
DATAIKU+
ZAPIER+
WORK RIDE+
AGILENT+
COCA-COLA+
AMERICAN EXPRESS+
GAF+
SOTHEBY'S+
MARGARITAVILLE+
MEDTRONIC+
DATAIKU+
ZAPIER+
WORK RIDE+
AGILENT+

GlideApps Agency builds production-ready FDA Compliance apps for enterprises and growth-stage companies — 350+ Glide apps delivered since 2019, with deep expertise in compliance & auditing. Projects start at $15,000 with typical delivery in 4–8 weeks.

350+
Glide Apps Delivered
4 wks
Avg. Delivery Time
90%
Client Retention
$40M+
Saved in Dev Costs

What does building a FDA Compliance app include?

Every engagement includes discovery, data architecture, UI/UX design, development, QA, and post-launch support — not just a build-and-handoff.

Discovery & Architecture

Requirements mapping, data modeling, integration planning, and platform-fit assessment before a single screen is built.

UI/UX Design

Wireframes and interactive prototypes designed for your users — not generic templates. Optimized for mobile and desktop.

Development & QA

Built by certified Glide experts with enterprise experience. Rigorous testing across devices, roles, and data volumes.

Launch & Support

User training, documentation, and ongoing maintenance. We don't disappear after deployment.

Key features of your FDA Compliance app

Deviation & Nonconformance Management

Capture deviations, nonconformances, and out-of-specification results immediately with full documentation — including product lot, process step, investigator, and disposition — to support FDA inspection review.

CAPA Management

Manage your corrective and preventive action program from initiation through root cause analysis, action plan, implementation, and effectiveness check — with the documentation trail FDA expects.

Training Compliance Records

Track FDA-required training by role, procedure, and document version. When SOPs are revised, training assignments are automatically generated and tracked to completion before employees work with the updated procedure.

Inspection Readiness Dashboard

Monitor your compliance posture in real time — open deviations, overdue CAPAs, training gaps, and document control status — so you're never caught unprepared when an FDA investigator arrives.

Who uses a FDA Compliance app?

+A Class II medical device manufacturer uses the app to manage their 21 CFR Part 820 QMS — deviations, CAPAs, and supplier audits are all managed in one system, and FDA inspection preparation time has dropped from 3 weeks to 3 days.
+A pharmaceutical contract manufacturer tracks batch deviations and CAPAs across multiple product lines — every deviation is captured in real time, root cause analysis is completed in the app, and investigators have a complete history at their fingertips.
+An FSMA-regulated food manufacturer manages their preventive controls program in the app — monitoring records, corrective actions, and supplier verification activities are all maintained digitally and available for FDA inspection.

How much does a FDA Compliance app cost?

Projects start at $15,000 for internal business apps. Most clients invest $40,000–$80,000 annually across development, iteration, and support.

Project TypeTimelineStarting At
Internal Business App4–6 weeks$15,000
Client-Facing Portal4–6 weeks$20,000
Enterprise Platform6–8 weeks$40,000
Multi-App Architecture8–12 weeks$50,000+

The Glide Sprint Process

How we build your FDA Compliance app

01

Discovery

Requirements, data modeling, and platform-fit assessment. We define scope before writing a line of logic.

02

Architecture

Data structure, security model, integration map, and user roles. The blueprint that prevents rework.

03

Build

Iterative development with weekly demos. You see progress, not just status updates.

04

QA & Launch

Cross-device testing, user acceptance, and production deployment with rollback safety.

05

Support

Ongoing maintenance, feature iterations, and scaling support. We don't disappear after launch.

Frequently asked questions about FDA Compliance apps

Does the app support 21 CFR Part 11 electronic records requirements?+
We design apps to address Part 11 principles — electronic signatures, audit trails, and access controls — but full Part 11 compliance depends on your validation approach and data infrastructure. We work with your quality and IT teams to scope appropriately.
How does the app handle out-of-specification (OOS) investigations?+
OOS events trigger a structured investigation workflow in the app — Phase 1 laboratory investigation, Phase 2 full-scale investigation if needed, disposition decision, and CAPA if warranted. Every step is documented with approvals and timestamps.
Can the app manage supplier qualification and incoming material inspection?+
Yes. We build supplier qualification and receiving inspection modules that link to your approved supplier list, track inspection results by lot, and flag non-conforming material for disposition — supporting your supply chain quality obligations.
What types of FDA-regulated products have you built compliance apps for?+
We've built FDA compliance apps for 21 CFR Part 820 medical devices, 21 CFR Parts 210/211 pharmaceuticals, 21 CFR Part 117 (FSMA) food manufacturers, and cosmetics companies. Each app is structured to the specific regulatory requirements.
How long does it take to implement an FDA compliance app?+
A comprehensive FDA compliance app typically takes 8–12 weeks depending on scope — deviation management, CAPA, document control, and training tracking each add complexity. We phase implementations to deliver value quickly while building toward the full system.

Related apps you might need

Compliance Management App

Compliance & Auditing

Compliance Tracker App

Compliance & Auditing

Regulatory Compliance App

Compliance & Auditing

Audit Management App

Compliance & Auditing

Internal Audit App

Compliance & Auditing

Explore all our Compliance & Auditing apps built with Glide.

★★★★★

“We were always impressed with the way they deliver on our vision.”

Albert La Grange — President, La Grange International

4.9
★★★★★
34 reviews on Clutch

Ready to build your FDA Compliance app?

Schedule a consultation with our Senior Partners. We'll scope your project, recommend the right approach, and deliver in 4–8 weeks.