Pharmacovigilance and drug safety
Teams that receive, triage and report adverse events.
- Intake forms for call centers, field reps and patients
- Case triage with seriousness and expectedness flags
- Deadline tracking for 15-day alert reports
Healthcare / Pharmaceutical
Pharmaceutical software development
Pharma teams run on systems that must prove who did what and when: adverse event intake, batch and quality records, serialization, and field tools for medical affairs. Agnotic Technologies builds this software for pharmaceutical companies, with 21 CFR Part 11 audit trails and validation evidence designed in.
Part 11
Audit trails and electronic signatures
DSCSA
Package-level product tracing
15 days
Serious, unexpected adverse events to FDA
Trusted by global innovators
Industry Overview
What is pharmaceutical software development?
Pharmaceutical software development is building the systems a pharmaceutical company runs outside the clinic: pharmacovigilance intake, quality and batch records, serialization and traceability, and commercial and medical affairs tools. Agnotic Technologies builds these systems for pharma teams as a services engagement, with 21 CFR Part 11 audit trails, validation evidence and data integration designed in from the first release.
Who we build for
Which pharma teams ask us for custom software?
Each function in a pharmaceutical company has its own records, its own regulator-facing deadlines and its own gaps between packaged systems.
Quality and manufacturing
QA and operations teams working under CGMP rules.
- Deviation and CAPA tracking
- Batch record review and release workflow
- Training and document control
Supply chain and serialization
Teams responsible for DSCSA product tracing.
- Product identifier capture at pack and case level
- Transaction data exchange with trading partners
- Illegitimate product investigation and notification
Commercial and medical affairs
Field and HQ teams that work with HCPs and payers.
- HCP engagement and medical information request tools
- Sample management and spend records
- Market access and formulary trackers
Industry Challenges
Where do pharma systems usually break?
Failure points we see most often when a pharmaceutical company audits its own software landscape.
Audit trail gaps: a record can be edited without a who, when and why, so it cannot be relied on in an inspection.
Spreadsheet handoffs: adverse event data moves from intake to the safety database by email, and deadlines are tracked by hand.
Unvalidated changes: a configuration change ships without a documented test, and the validated state is lost.
Serialization islands: the packaging line, the ERP and the trading partner portal each hold a different version of the product trace.
Field tools without controls: reps capture HCP interactions in consumer apps with no retention or access rules.
Decision table
Which rules apply to each pharma system?
Not every system in a pharmaceutical company is a GxP system. This table is how we decide, on the scoping call, which controls a build needs.
| System | Governing rules | What the software must do | Validation depth |
|---|---|---|---|
| Pharmacovigilance intake | 21 CFR 314.80, 21 CFR Part 11 | Capture cases, flag serious and unexpected events, track the 15-day clock | Full: audit trail, e-signatures, test evidence |
| Batch and quality records | 21 CFR Part 211, 21 CFR Part 11 | Record complete data, back it up, check inputs and outputs | Full |
| Serialization and tracing | DSCSA | Hold product identifiers and transaction data, support 24-hour illegitimate product notices | Full for tracing data |
| Medical information requests | Internal SOPs, privacy law | Log requests and responses, control access | Moderate: access and retention controls |
| HCP engagement and field tools | Privacy law, company policy | Record interactions, enforce spend and sample rules | Moderate |
| Internal analytics and reporting | Depends on the data source | Read from validated systems without altering them | Light, unless used for GxP decisions |
Our Approach
How do we build GxP-aligned software?
Controls are design decisions, not a document written at the end. These are the ones every regulated build gets.
Audit trail by default
Every create, update and delete on a regulated record stores who, when, the previous value and the reason.
Electronic signatures
Signature meaning, re-authentication and signer identity on records that need them, per 21 CFR Part 11.
Validation evidence as you go
Requirements, risk assessment, test scripts and traceability written during the build, so the validated state is documented, not reconstructed.
Capabilities
What we build for pharmaceutical companies
Common systems, each delivered as a fixed-scope first release that can grow.
Adverse event intake
Web, mobile and call-center intake with seriousness triage and handoff to your safety database.
Quality management workflows
Deviations, CAPA, change control and training records with approval chains.
DSCSA traceability
Product identifier capture, transaction data exchange and investigation records for suspect product.
Medical affairs tools
Medical information request handling, standard response libraries and HCP interaction logs.
Commercial data integration
Pipelines that bring CRM, sample, spend and market data into one governed model.
Patient support program apps
Enrollment, adherence reminders and hub services, with HIPAA safeguards where PHI is involved.
Engineering Stack
Technologies we use for pharma builds
Chosen for traceability, long support windows and fit with your existing platforms.
Records and signatures
PostgreSQLEvent-sourced audit logPKI-backed e-signatures
Integration
REST and GraphQL APIsSFTP and AS2 exchangeEPCIS for serialization data
Apps
Next.jsReact NativeSwiftKotlin
Cloud
AWSAzureGoogle Cloud
Measured Impact
What drives the cost of pharmaceutical software?
There is no fixed price. These are the factors that move effort most, and we size each on the scoping call.
Validation
Depth of CSV or CSA evidence
A GxP system needs requirements, risk assessment, test scripts and traceability; a reporting tool needs far less.
Integrations
Systems to connect
Safety databases, ERP, CRM, document management and trading partner exchanges each add interface work.
Signatures
Records needing e-signatures
Each signature point adds meaning text, re-authentication and signer records.
Migration
Legacy data to move
Historical cases, batch records and trace data must be migrated with their audit history intact.
My Lauren Maternal Health Platform | Built by Agnotic
A HIPAA-ready maternal health platform enabling remote patient monitoring, care coordination, and personalized engagement from pre-pregnancy through postpartum.
Case Study
LERA Health: Compliant Women’s Health App Platform
A women’s health product experience focused on guided care journeys, education, and compliance-aware workflows to support long-term engagement.
Case Study
Use Cases
Where does custom pharma software pay off first?
First releases we scope most often with pharmaceutical teams and pharmaceutical startups.
01
Adverse event intake portal
One intake path for call center, field and patient reports, with the 15-day clock visible from receipt.
02
Deviation and CAPA tracker
Replaces a spreadsheet with an approval workflow and an audit trail.
03
DSCSA exception handling
A queue for mismatched or missing trace data, with investigation records and notification support.
04
Medical information desk
Request logging, standard responses and reporting for medical affairs.
05
Field data capture
Mobile tools for reps and MSLs with retention and access rules built in.
06
Commercial data platform
A governed data model that replaces competing spreadsheets across sales, access and marketing.
Integrations
Which systems do pharma builds connect to?
The platforms a pharmaceutical company usually already runs.
Pharmacovigilance
Safety databases
Manufacturing
ERP and MES
Quality
Electronic document management
Commercial
CRM
Supply chain
Serialization and EPCIS repositories
Security
Identity providers (SSO)
Self-assessment
Validation checklist for a new pharma system
What we agree with your quality team before the first release of any GxP-impacting system. Use it to check a vendor, too.
Compliance-First Development Services Backed by Global Standards
We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.
Our Edge
Why Global Leaders Choose Us
We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.
Enterprise-Grade Security
We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.
High-Performance Scaling
Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.
Accelerated Time-to-Market
Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.
Embedded AI Integration
Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.
Engagement Model
How does a pharma engagement work?
Timing depends on scope and validation depth. We agree a fixed first release on the scoping call.
01
Scoping call
We agree the system, its users, the rules that apply and the systems it must connect to.
02
Requirements and risk
User requirements and a risk assessment reviewed with your quality team.
03
Fixed-scope first release
One workflow built with weekly demos, audit trail and test evidence from the first sprint.
04
Validation and go-live
Executed test scripts, traceability and a change control procedure handed over with the release.
05
Support and change control
Later releases follow the same documented path, so the system stays validated.
Facts and sources
Rules behind pharmaceutical software
Facts we design around, each linked to its primary source.
21 CFR Part 11 sets FDA's requirements for electronic records and electronic signatures, including secure, computer-generated audit trails.
Source: 21 CFR Part 11 (eCFR)Under 21 CFR 314.80, an applicant must report each adverse drug experience that is both serious and unexpected to FDA as soon as possible and no later than 15 calendar days from initial receipt of the information.
Source: 21 CFR 314.80 (eCFR)21 CFR 211.68 requires that computers used in drug manufacturing have input and output checked for accuracy and that a backup file of entered data is maintained, secure from alteration, inadvertent erasure or loss.
Source: 21 CFR 211.68 (eCFR)The Drug Supply Chain Security Act sets out steps toward an electronic, interoperable system to identify and trace certain prescription drugs at the package level, and trading partners must notify FDA within 24 hours of determining that a product is illegitimate.
Source: FDA, Drug Supply Chain Security Act (DSCSA)
Voice of success
We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.
“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”
Aaron Phelan
Founder, Benchmark
“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”
John Pasmore
Founder, Latimer
“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”
Kim Smith
Founder, My Lauren
Related pages
Related services for pharma teams
Detailed pages for the work that usually sits next to a pharma build.
Life sciences and clinical trial software development
Trial matching, eConsent and data capture for studies, covered on its own page.
Data engineering services
Governed pipelines for safety, commercial and supply chain data.
QA and software testing services
Test scripts, automation and evidence for validated systems.
HIPAA requirements for software teams
The safeguards we apply when a pharma program handles patient data.
Custom healthcare software development
Our main service page for custom healthcare builds.
System integration services
Connecting safety, ERP, CRM and document systems.
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Cross-Industry Reach
The Same Engineering Patterns, Across Other Industries
The technical patterns behind this platform translate naturally into adjacent verticals.
Frequently Asked Questions
It depends on scope, the number of integrations and the validation depth the system needs. We agree a fixed-scope first release on the scoping call and give you its timeline before work starts.
Often not directly: most pharma systems hold no protected health information from a covered entity. Patient support programs, hub services and some pharmacovigilance intake can involve PHI, and for those builds we apply HIPAA safeguards and sign a business associate agreement where one is needed.
We produce the validation evidence as part of the build: requirements, risk assessment, test scripts, executed results and traceability. Your quality unit reviews and approves it, and the change control procedure we hand over keeps the system validated after go-live.
No. Clinical trial software (trial matching, eConsent, electronic data capture) is covered on our life sciences page. This page covers the systems a pharmaceutical company runs outside the study: safety intake, quality records, serialization and commercial tools.
Yes. We connect through the vendor's APIs or file exchanges, keep the integration logic outside the validated system where possible, and document each interface so it can be tested on its own.
Yes. Most engagements start with one workflow for one team, such as adverse event intake or a deviation tracker, running in production before more functions and integrations are added.
AI tools help our engineers draft code and tests, but a person reviews every change, and it passes the same automated tests, security checks and validation steps as any other code.
Industries