Develop 21 CFR Part 11 Compliant FBD Software

About the project

**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.**

Skills required