Industry
Pharma & Life Sciences
GMP Compliance, Guaranteed
Electronic batch records, validated work instructions, and complete audit trails. Meet FDA 21 CFR Part 11 and EU Annex 11 with a platform built for the pharmaceutical industry.
Why Slimme Fabriek?
Data integrity is non-negotiable
In the pharmaceutical industry, every deviation is a risk. Paper-based processes are error-prone and difficult to validate. We offer a fully digital platform with built-in compliance: electronic signatures, version control, and complete traceability of every action.
The Challenge
Challenges You'll Recognize
Critical issues in pharmaceutical production
Data Integrity
ALCOA+ principles require every data entry to be attributable, legible, contemporaneous, original, and accurate. Paper fails on multiple points.
Validation Burden
Every SOP change requires a validation cycle. Paper processes make this slow and labor-intensive.
Human Error
Complex procedures with dozens of steps. One missed step can lead to a rejected batch or worse.
The Solution
Our Solutions for Pharma
Validated tools for the pharmaceutical industry
Electronic Batch Records
Automatic registration of process data with timestamps, operator ID, and device information. No more handwritten entries.
Validated Work Instructions
Version control with approval workflows. Operators always see the current, approved version.
Electronic Signatures
21 CFR Part 11 compliant e-signatures with dual verification for critical steps.
Deviation Management
Deviations automatically create a record with all context for CAPA analysis.
Training & Qualification
Digital training records with knowledge tests. Operators can only execute procedures they're qualified for.
Audit Trail Reporting
Generate complete audit trails for inspections in seconds. Who did what, when, and with what result.
Your Benefits
Measurable Results
What pharmaceutical companies achieve with our platform
Data Integrity
No handwritten entries, no transcription errors. ALCOA+ compliance by design.
Validation Time
Change control and validation are built-in. Changes go through digital approval workflows.
Observations
Customers report significantly fewer FDA/EMA observations related to documentation.
Audit Response
Inspectors get requested documentation in minutes, not hours or days.
Use Cases
Real-World Examples
Batch Release Review
QA reviews the complete electronic batch record. Every step has timestamps, e-signatures, and any deviations automatically linked.
Cleaning Validation
Cleaning procedures with mandatory photo uploads and swab results. System blocks production until validation is complete.
Training After SOP Change
New SOP version published. All affected operators automatically receive retraining notification and must pass knowledge test.
FDA Inspection
Inspector requests audit trail for specific batch. Generated within 2 minutes as PDF with all signatures and timestamps.
Relevant Modules
Modules for Pharma
Validated modules for GMP environments
Frequently Asked Questions
Veelgestelde Vragen
Is the platform validated?
Yes, we deliver an IQ/OQ package and support your PQ. The platform is designed according to GAMP 5.
How do electronic signatures work?
Operators authenticate with username + password or badge + PIN, compliant with 21 CFR Part 11 requirements.
Can we import existing SOPs?
Yes, we support import of Word/PDF documents and help with conversion to interactive procedures.
What about CSV (Computer System Validation)?
We provide extensive documentation for your CSV file, including requirements, test protocols, and traceability matrices.
Ready to get started?
Discover how Slimme Fabriek can transform your production.