Develop 21 CFR Part 11 Compliant FBD Software

**Freelancer Required – 21 CFR Part 11 Compliant Software Development for FBD Machine**

We are looking for an experienced **21 CFR Part 11 / GxP Automation / CSV professional** to develop and implement a compliant software system for an existing **Fluid Bed Dryer (FBD) machine** currently operating with a non-compliant control/software system.

We will provide all necessary machine details, existing PLC/HMI program information, I/O details, process parameters, batch sequence, existing reports, and other technical information required for the project.

The freelancer should have **strong practical experience in 21 CFR Part 11 compliance and pharmaceutical automation**, preferably with multiple projects completed from **requirement gathering through development, validation, commissioning, and final execution**.

### Scope of Work

The freelancer will be responsible for recommending, developing, configuring, and implementing the complete software solution, including:

* **Required software/platform**

* Recommended technology/platform and architecture
* PLC/HMI/SCADA/database integration, as applicable
* Local/server-based architecture
* Communication protocols and data acquisition

* **Required licenses**

* Software/platform licenses
* Runtime/development licenses
* Database licenses, if required
* Historian/reporting licenses, if required
* License type, quantity, and estimated cost

* **User Management & Security**

* User creation and management
* Role-based access control
* Password policies
* User authorization levels
* Account lockout/security features
* Administrator controls

* **Electronic Records & Electronic Signatures**

* Secure electronic records
* Electronic signature implementation
* Signature levels/meaning
* Signature authentication and traceability

* **Batch Management & Reporting**

* Batch creation and management
* Batch-wise data recording
* Batch report generation
* Report printing/export
* Date/time and user traceability
* Parameter and alarm/event records

* **Audit Trail**

* Automatic audit trail generation
* Recording of critical data changes
* User/date/time/action tracking
* Audit trail review functionality
* Protection against modification/deletion

* **Data Storage & Retrieval**

* Secure database/data storage
* Data integrity
* Data retrieval and search
* Historical data viewing
* Data retention requirements

* **Backup & Archival**

* Automatic/manual backup strategy
* Backup frequency
* Restoration procedure
* Archival strategy
* Disaster recovery considerations

* **Additional Hardware/Software**

* Server/industrial PC requirements
* UPS/network requirements
* Database/server requirements
* Additional hardware/software required for compliance

### Documentation & Validation

A major requirement is preparation of the documentation necessary for a **21 CFR Part 11 / GxP-compliant and validated system**.

The freelancer should be capable of preparing or supporting documents such as:

* User Requirement Specification (URS)
* Functional Specification (FS)
* Software/Hardware Design Specification, as applicable
* Risk Assessment
* Traceability Matrix
* Configuration/Design documentation
* Test protocols
* FAT/SAT documentation
* IQ/OQ documentation
* Validation/qualification documentation
* SOPs related to system operation, user management, backup, audit trail review, etc.
* Electronic signature and security procedures
* Change control documentation
* Deviation/CAPA documentation, where applicable
* Final validation/commissioning documentation

The exact documentation package should be proposed by the freelancer based on the intended system, site requirements, and applicable GxP/CSV requirements.

### Freelancer Qualifications

**Mandatory:**

* Proven experience with **21 CFR Part 11**
* Practical experience in **pharmaceutical/regulated manufacturing**
* Experience with electronic records, electronic signatures and audit trails
* Experience with PLC/HMI/SCADA/database integration
* Experience in CSV/CSA/GxP validation
* Experience taking projects from **URS → Development → FAT/SAT → IQ/OQ → Validation/Execution**
* Ability to prepare complete compliance/validation documentation

**Preferred:**

* Previous experience with **FBD, RMG, Blender, Compression, Coating or other pharmaceutical equipment**
* Experience with industrial automation platforms such as Siemens, Rockwell, Omron, WinCC, Ignition, AVEVA/Wonderware or equivalent
* Experience with SQL databases and industrial data historians
* Experience implementing secure user management and electronic signatures

### Important

We are **not looking for only a software programmer**.

We need a person who can take responsibility for the **complete technical and compliance approach**, recommend the appropriate software/platform and licensing, develop the system, integrate it with the existing FBD machine, and provide/support the required validation documentation.

We will provide all available technical information and necessary machine/process details.

### Proposal Requirements

Please provide:

1. Brief description of your relevant 21 CFR Part 11 experience
2. Number/type of pharmaceutical automation projects completed
3. Examples of similar projects, especially FBD or other pharmaceutical machines
4. Recommended software/platform and reason for selection
5. Proposed architecture
6. Required software/licenses and license types
7. Estimated development/implementation timeline
8. Scope of documentation and validation support
9. What will be included in your quotation
10. Any hardware/software required from our side
11. Support/warranty period after commissioning
12. Commercial proposal – preferably separated into development, licenses, documentation/validation, commissioning and support

**Please apply only if you have hands-on experience implementing and validating 21 CFR Part 11/GxP systems in pharmaceutical or other regulated environments.**