Synerlution resources have more than 20 years of experience working in the qualification and validation of industrial Automation, Control Systems, IT Solutions, Databases, Custom Software Development, and Disaster Recovery Methods throughout the complete project lifecycle including Systems Operation, Training, Maintenance, Decommissioning, and Retirement.
As part of the documentation package, our services include:
- User Requirements Specification (URS)
- Functional Design Specifications (FDS)
- System Requirements Specifications (SRS)
- System Design Specifications (SDS)
- System Configuration Specifications (SCS)
- System Design & Data Integrity by Design Specifications
- Mechanical, Electrical, Wiring, and Technical Design Specifications
- Data Migration Plan and Report
- Serialization Requirements Specifications
- Traceability Matrix (TM)
PROTOCOLS &
REPORTS
- Computer Software Validation (CSV)
- Software Validation (SV)
- Equipment Validation
- Process Validation (PV)
- Factory / Site Acceptance Test (FAT/SAT)
- Commissioning / Qualification of Equipment
- Installation Qualification (IQ)
- Installation / Operational Qualification (IOQ)
- Operational Qualification (OQ)
- Test Method Validation (TMV)
- Performance Qualification (PQ)
- Spreadsheet Validation
- System Decommissioning & Retirement
- Data Migration Validation
PAPERLESS VALIDATIONS
- Data Gathering and Analysis
- Statistical Data Evaluation and Analysis
- Standard Operating Procedures (SOPs)
- Work Instructions (WIs)
- Administrator and User Manuals
- Backup and Disaster Recovery Procedures
- Security and System Administration
- Periodic Review
- Backup and Restore
- Disaster Recovery and Business Continuity
EXPERIENCE HIGHLIGHTS
- Programmable Logic Controller (PLC) for Controlled Packaging Equipment
- Human-Machine Interface (HMI)
- Supervisory Control and Data Acquisition (SCADA)
- Distributed Control Systems (DCS)
- Inspection and Vision Systems
- Manufacturing Execution Systems (MES)
- Batch Record Systems
- Security and Access Control Systems
- Building Management Systems (BMS)
- Building Automation Systems (BAS)
- Process Automation Systems (PAS)
- Laboratory Information Management Systems (LIMS)
- Systems Application and Product (SAP)
- Environmental Monitoring Systems
SYNERLUTION IS
CERTIFIED
At Synerlution we have certified professionals that can provide implementation and configuration services to make the transition to paperless validation as smooth and efficient as possible.
Schedule an appointment for orientation with Synerlution. We can help you define the solutions that best feed your needs in both execution and time of implementation.