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01 / Custom software

The system follows the process.

Designed around the client’s roles, documents and regulatory obligations. Delivered with its validation documentation.

RIMPharmacovigilanceQualitySupplierGAMP 5CSAAnnex 1121 CFR Part 11

Four areas.

Regulatory Information Management

Product master data, registrations by country, variations, renewals, submissions and commitments.

Pharmacovigilance

ICSR intake and tracking, expedited reporting timelines, PSMF, safety data exchange agreements.

Quality Management

GxP document control, change control, deviations and CAPA, product quality complaints, inspection readiness.

Supplier & Contract Management

Quality agreements, service contracts, supplier qualification and audits, budgets and invoices.

Reference systems.

Developed for a mid-sized pharmaceutical group with international operations.

Regulatory Information Management
1
Regulatory Information ManagementPortfolio, registrations by country, dossiers, variations.
In service
Document Management
2
Document ManagementeCTD structure, versions, approval flows, distribution to affiliates.
Agreement Management
3
Agreement ManagementContracts, budgets, projects and invoices by provider.

Screens show demonstration data.

Beyond pharma · In service

Psychology practice, five sites

One management system, same method.

5sites
30professionals
Bookings
Payments
Therapist record
Patient record

Rules applied, by product type.

Medicinal products
Medical devices
Cosmetics
Registration
National, MRP, DCP, centralised · eCTD
MDR · EUDAMED · UDI
Reg. (EC) 1223/2009 · CPNP
Vigilance
Pharmacovigilance · GVP Modules VI and IX
Medical device vigilance · MDR arts. 83-88
Cosmetovigilance · Reg. 1223/2009 art. 23
Quality
EU GMP Part I
ISO 13485
ISO 22716

Validation · built on the client’s URS. Starting documentation is available for systems similar to those already developed.

GAMP 5Risk-based CSAEU GMP Annex 1121 CFR Part 11

How a system is delivered.

The method
1
Process analysisCurrent process and applicable obligations.Process map
2
SpecificationUser requirements approved by the client.URS
3
DevelopmentIterative releases in a test environment.Working versions
4
ValidationPackage approved before go-live.VMP · IQ/OQ/PQ · Trace matrix
5
OperationMaintenance and periodic review.Change log · Review

Why custom.

Regulatory complexity is driven by how a company is organised, not by its size.

Enterprise suite
Custom system
Starting point
The vendor’s data model
The client’s process and obligations
Scope
Complete suite, often only partly used
One system at a time, sized on the need
Cost
Annual licence per user, plus implementation
Development and maintenance only
Budget
Fixed product scope and price list
Functions defined within the available budget
Ownership
Remains with the vendor
The client’s: code, documentation, validation
Exit
Dependent on the vendor’s expertise and roadmap
Oracle technology, widely used languages: maintenance can move to another provider or to in-house IT

A single, controlled source of regulatory data

ExcelSharePointEmailPublishingERP
Controlled regulatory data
Product›Country›Authorisation›Submission›Commitment›Document
owners · audit trail · access rules · history
Oversight. Deadlines, countries and owners, currently tracked by hand across spreadsheets.

Designed around the budget

Scope and functions set on what the company can invest.

Released in phases

Priority functions first, extended over time.

Competitive cost

No licence, no per-user fees.

Let’s look at your process.

Demonstration of the reference systems on request.

Discuss a project