Overview
Compliance is not a document you write at the end. It is a set of engineering constraints that must be reflected in materials, safety design, traceability, and change control from day one. Motionwell supports compliance-driven automation for medical device and pharmaceutical environments with a practical, evidence-focused approach.
Compliance Areas We Commonly Support
| Compliance area | Typical requirement | What we engineer for |
|---|
| Medical device quality | ISO-aligned quality expectations (project-dependent) | Stable processes, traceability, controlled changes, documentation readiness |
| Pharmaceutical operations | GMP constraints (project-dependent) | Clean design, maintainability, operator workflows and training evidence |
| Electronic records | 21 CFR Part 11 style patterns (when required) | Audit-friendly data capture, access controls, traceability model |
| Functional safety | ISO 12100 + ISO 13849 approach (project-dependent) | Risk assessment, safety functions, validated stop and recovery behavior |
| Validation | IQ/OQ/PQ support (project-dependent) | Protocol templates, evidence collection strategy, execution support |
Project References (Examples)
| Project reference | Compliance-relevant focus | Delivered implementation (high-level) |
|---|
| Project 0023 (Pharmacy Automation) | Coding verification and controlled rejects | HMI reporting plus verification outputs supporting regulated workflows |
| Project P23078 (QA Lab Automation) | Traceability and result handling | Controlled sample state transitions with result auto-naming and server upload patterns |
Documentation and Validation Deliverables (Project-Dependent)
| Deliverable | Purpose |
|---|
| URS / FS / DS | Align requirements to design and provide traceable justification |
| FAT / SAT evidence | Demonstrate performance and interfaces before and after installation |
| IQ / OQ / PQ support | Structure qualification evidence where required |
| Risk assessment records | Make hazards and mitigations explicit and reviewable |
Frequently Asked Questions
| Question | Answer |
|---|
| Do you provide URS/FS/DS and validation documents? | Yes, when the documentation scope is defined. We align deliverables to your quality system so evidence is usable during audits and future change control. |
| Can you support 21 CFR Part 11 style requirements? | Yes, when required. The key is defining the traceability model, audit expectations, access control needs, and data retention rules early. |
| Which safety standards do you design to? | We typically use ISO 12100 for risk assessment and ISO 13849 for safety function design, with project-dependent requirements based on region and customer policy. |
To plan compliant automation, contact us at /contact/ with your target standards, cleanroom requirements, and validation expectations.
See compliance-driven automation in action: Medical Automation | QA Lab Automation
