Documentation IS the product.Faulty documentation = recalled product.
Pharmaceuticals, medical devices, and biotech place extreme demands on traceability and documentation. AmpliFlow gives you a flexible tool for quality management — complementing your regulatory systems.
Regulated industry, high demands
GMP, GDP, ISO 13485 — the requirements are many and the consequences of gaps are serious.
Documentation and traceability
GMP and ISO 13485 require complete traceability. Without structured systems, demonstrating traceability during inspections becomes difficult.
Deviation handling and CAPA
Deviations must be handled with root cause analysis and verified actions. Manual processes make it hard to track status and deadlines.
Training and competence records
GMP requires documented training for all staff. Tracking who's read which SOPs and which competencies need renewal is time-consuming.
Supplier qualification
Critical suppliers must be qualified and monitored. Without a system, tracking audits, approvals, and requalifications is challenging.
An important note about validation
AmpliFlow is a flexible quality management tool suitable for overall QMS work. The system is not validated per 21 CFR Part 11 and does not replace dedicated GxP systems for regulated processes. However, AmpliFlow can complement your existing systems by handling overarching processes that don't require validated systems.
Which ISO standards apply?
The standard choice depends on your business and which regulatory requirements you face.
ISO 9001
Quality Management
Foundation for quality management systems. Often used alongside GMP requirements for an overarching quality system.
Learn more about ISO 9001ISO 13485
Medical Devices
Specific standard for medical device manufacturers. Requirements for design, manufacturing, and traceability.
Learn more about ISO 13485ISO 27001
Information Security
Protects sensitive research data and patient information. Increasingly important for clinical trials and data management.
Learn more about ISO 27001Support for your quality management work
Flexible tools that complement your regulatory systems — not replace them.
Deviation handling with workflows
Register deviations and follow them through steps: registration, investigation, action, and verification. Similar to CAPA in a flexible tool.
Document management with traceability
Organize SOPs, work instructions, and procedures in folders with permissions. See who last modified each document.
Competence matrices and training plans
Document what competencies employees have and need. Create training plans and follow up on completed training.
Checklists for controls
Create checklists with 16+ field types for environmental controls, cleaning verification, or incoming inspection. Schedule recurring controls.
Supplier register
Track qualified suppliers, approval status, and when requalification is needed.
Risk assessments
Document risks with probability and consequence. Link actions to responsible parties and follow up on completion.
What you can expect
documentation
Centralized documentation makes it easier to demonstrate traceability during inspections.
overview
See status on deviations, training, and calibration dates in one system instead of Excel.
follow-up
Workflows help you follow up that actions are completed and verified on time.
start
Start with what's most important and expand over time. No validation requirement to get started.
Questions about AmpliFlow for life science
Honest answers — we tell you what fits and what doesn't.
Is AmpliFlow validated per 21 CFR Part 11?
No. AmpliFlow is not validated per 21 CFR Part 11. It's a flexible tool for overarching QMS work. For GxP-regulated processes, you need other solutions. AmpliFlow can complement by handling training documentation, supplier management, and overarching processes.
How does AmpliFlow fit in a GMP-regulated company?
AmpliFlow can be used at the overarching level: deviation handling, document control for SOPs, competence matrices, and supplier registers. For GMP-critical processes requiring electronic signatures and audit trails, you need dedicated validated systems.
Can we use AmpliFlow for CAPA management?
AmpliFlow has deviation handling with workflows similar to the CAPA process. You can customize the workflow to your needs. Note that for formal CAPA per GxP requirements, validated systems may be required.
Which ISO standard is relevant for us?
Depends on your business. Medical devices: ISO 13485. Overall quality management: ISO 9001. Research data and patient information: ISO 27001.
What does AmpliFlow cost?
Pricing depends on company size and how much support you need. See current pricing on our pricing page.
Want to know more?
Book a demo and we'll show you how AmpliFlow can support your quality management work. We're honest about what fits and what doesn't.