Stage One Computing
Stage One Computing specializes in providing customized business-critical solutions and consulting in Validation, Industrial Automation, and IT systems. Their focus is on automation and optimization of documentation processes and manual or semi-automated processes, offering solutions based on standard systems tailored to customer needs. They aim to help pharmaceutical companies and suppliers produce the best products at the lowest cost through effective structures, rational approaches, thorough risk assessment, and understanding regulatory requirements.
Industries
Nr. of Employees
small (1-50)
Stage One Computing
Products
SOCPDFtool
Scriptable tool to convert PDFs to ISO 19005 (PDF/A), merge files, attach documents, and perform batch signing for GxP-compliant archival and audit-trail generation.
SOCopy
Tool to perform validated file copy operations between drives or to FTPS servers with checksum verification and generation of a PDF report documenting the transfer and integrity.
SOCePRINT
Hardware/software solution that captures PCL/PS/ASCII printer outputs (RJ45/RS232/USB) and converts them into structured PDF files, optionally including scanned images and machine-readable text for system integration.
SOCPDFtool
Scriptable tool to convert PDFs to ISO 19005 (PDF/A), merge files, attach documents, and perform batch signing for GxP-compliant archival and audit-trail generation.
SOCopy
Tool to perform validated file copy operations between drives or to FTPS servers with checksum verification and generation of a PDF report documenting the transfer and integrity.
SOCePRINT
Hardware/software solution that captures PCL/PS/ASCII printer outputs (RJ45/RS232/USB) and converts them into structured PDF files, optionally including scanned images and machine-readable text for system integration.
Services
End-to-end validation support including validation planning, DQ/IQ/OQ/PQ protocol development, execution and reporting for equipment and systems in regulated manufacturing.
Validation and compliance review of laboratory and IT systems, audit-trail reviews, remediation of inspection observations and IT security uplift.
Analysis and optimization of packaging and production equipment, reduction of critical parameters, bottleneck removal and OEE improvement to delay or avoid capital expenditure.
Coordination and execution of cleaning-validation pre-tests and tests across multiple tanks and configurations while production continues.
Project leadership for GMP construction and change projects, including change requests, risk assessments and execution of qualification and validation deliverables.
Provision of standardized templates and checklists (code-review, audit-trail checklist, test protocol templates) to support repeatable GxP processes.
End-to-end validation support including validation planning, DQ/IQ/OQ/PQ protocol development, execution and reporting for equipment and systems in regulated manufacturing.
Validation and compliance review of laboratory and IT systems, audit-trail reviews, remediation of inspection observations and IT security uplift.
Analysis and optimization of packaging and production equipment, reduction of critical parameters, bottleneck removal and OEE improvement to delay or avoid capital expenditure.
Coordination and execution of cleaning-validation pre-tests and tests across multiple tanks and configurations while production continues.
Project leadership for GMP construction and change projects, including change requests, risk assessments and execution of qualification and validation deliverables.
Provision of standardized templates and checklists (code-review, audit-trail checklist, test protocol templates) to support repeatable GxP processes.
Expertise Areas
- GxP validation and compliance
- Computerized system validation (CSV)
- Validated data transfer and data integrity
- Document digitization and archival (PDF/A)
Key Technologies
- PDF/A (ISO 19005) conversion and archival
- Checksum-based file integrity verification
- Batch scripting and configurator-driven automation
- FTPS / HTTPS file transfer protocols
News & Updates
Reduction of Downtime in Pharma Packaging Machines
Optimizing packaging machines to reduce critical parameters and increase stability, avoiding the need for new equipment.
Revalidation of Pharma Equipment with Minimal Downtime
A case where a revalidation was performed with only 2x4 hours of downtime, using review and rationalization instead of full revalidation.
Analysis of Old Equipment Documentation
Review and cataloging of documentation for older production equipment to ensure inspection readiness and compliance.
Implementation of Centralized Documentation System
Reducing documentation from 17 to 3 documents for production sites, with electronic signatures, saving time and increasing efficiency.
GMP Validation and Documentation for Building Projects
Managing validation plans and documentation for GMP compliance during construction and renovation projects.
Validation of HVAC Systems in Pharma Manufacturing
Qualification of HVAC zones with re-qualification projects, ensuring GMP compliance.
Reduction of Downtime in Pharma Packaging Machines
Optimizing packaging machines to reduce critical parameters and increase stability, avoiding the need for new equipment.
Revalidation of Pharma Equipment with Minimal Downtime
A case where a revalidation was performed with only 2x4 hours of downtime, using review and rationalization instead of full revalidation.
Analysis of Old Equipment Documentation
Review and cataloging of documentation for older production equipment to ensure inspection readiness and compliance.
Implementation of Centralized Documentation System
Reducing documentation from 17 to 3 documents for production sites, with electronic signatures, saving time and increasing efficiency.
GMP Validation and Documentation for Building Projects
Managing validation plans and documentation for GMP compliance during construction and renovation projects.
Validation of HVAC Systems in Pharma Manufacturing
Qualification of HVAC zones with re-qualification projects, ensuring GMP compliance.