Service and Validation Services
To ensure optimal equipment performance and maximum equipment up-time, we offer a range of extended warranties and service level agreements as well as initial and ongoing validation options.
Our global team of extensively trained and certified Field Service Engineers (FSEs) have both the knowledge and experience of not only our own equipment, but most existing legacy chambers. All our FSEs are qualified in Electrical, Mechanical, Refrigeration systems and adhere to cGMP guidelines for documentation generation and execution. Our FSEs will ensure your equipment is maintained and qualified with comprehensive documentation to support your regulatory requirements.
Regulatory Requirements
Service Level Agreements (SLA)
SBS has a range of standard SLAs to meet your requirements as well as a tailored solution:
| Extended Warranty | Level 1 | Level 2 | |
| Emergency Response | 24 Hour | 24 Hour | 48 Hour |
| Parts Included | Yes | No | No |
| Discount on Parts | N/A | Yes | Yes |
| Preventative Maintenance Visits (PMI) | 2 | 1 | 1 |
Validation / Commissioning
Using a combination of UKAS (United Kingdom Accreditation Service), NIST (National Institute of Standards and Technology) calibrated equipment and state-of-the-art data acquisition systems, we can offer extensive Temperature, Relative Humidity and light distribution mapping. Our field Service Validation Engineers (FVEs)will enhance uniformity to ensure all equipment is performing to optimum levels. All data acquisition systems used by our FVEs are fully configurable to the customers’ requirements, conforming with 21 CFR Part 11 and ensure data integrity throughout the validation process.
Using our standard templates or custom documentation we can generate comprehensive validation protocols that will demonstrate compliance to both ICH/MHRA guidelines and FDA requirements. Every aspect of validation and calibration can be undertaken, including:
- URS (User Requirements Specifications)
- FDS (Functional Design Specification)
- FAT (Factory Acceptance Test)
- IQ (Installation Qualification)
- OQ (operational Qualification)
- CQ (Calibration Qualification)
- PQ (performance Qualification)
Remote Monitoring
Benefits
- Alarm overview
- Alarm alerts via interactive phone, texts and E-Mails
- Full audit trail
- Monitor multiple locations
- Scalable
- Automatic report generation
- Customisation
- FDA 21 CFR Part 11 & EU Annex 11 complaint
- GAMP©5 conform for cGxP applications
Our range of data acquisition systems utilise the latest wireless technology allowing for collection of data from temperature and humidity sensors amongst other connectable inputs. With seamless integration into our i-Storage Client Portal or from multiple devices, users can monitor and control all aspects of the environmental chambers from one secure location using an internet connection.
The modular system of hardware elements and web-based software allows for maximum flexibility ensuring ease of installation and expandability.
The range of data loggers are designed to meet or exceed the requirements of 21 CFR Part 11 as well as EU Annex 11. The system has been designed to meet the requirements of GAMP5 (Category 4)
Remote Mapping
Benefits
- Cost Effective
- Saleable and Flexible
- Non-Intrusive
- Time Saving
- Report/Documentation Availability
- Full Traceability
- Fully compatible with i-Storage
Utilising our i-Storage client portal, you gain immediate access to our remote mapping service. This non-intrusive service utilises state of the art wireless mapping systems via the chambers internal communication devices to undertake mapping of environmental chambers at the touch of a button from one of our global validation hubs. Our Validation experts can remotely link to the chambers control systems via secure communication and undertake mapping activities remotely whilst generating comprehensive protocols delivered directly to the i-Storage client portal to demonstrate equipment compliance.