services and support
TRANSCRIPT
Services and Support
Providing complete lifecycle support of the Growth Direct™ System
Rapid Micro Biosystems is your partner from initial contact through purchase, installation and validation and continues to work with you after the Growth Direct™ System has gone into production. Our highly trained services staff are available every step of the way as consultants or fill resource gaps during validation.
Getting Prepared
Site Visit Support
To ensure successful installation and operation of the Growth Direct™ System, Rapid Micro Biosystems works with your facilities team and will visit the site to ensure that delivery
and assembly of the technology occurs with no issue, and that the needed infrastructure is in place to begin qualification as quickly as possible.
Feasibility Studies Optimized Processes
Prior to purchase of the Growth Direct™ System the Rapid Micro Biosystems technical team can assess your product samples to make sure that they are compatible with the Growth Direct™ Technology. These assessments are performed by on-staff microbiologists and results are published as an application report.
A member of the Rapid Micro Biosystems team can meet with you to discuss your current processes and offer strategies to simplify and accelerate the processing of samples even before they are loaded into the Growth Direct™ System.
QA Document Support
Rapid Micro Biosystems can meet with your Quality Assurance team to discuss documentation requirements and processes that must be completed internally to ensure a smooth and expedient validation process. Rapid Micro Biosystems provides document packages for the validation process that can be reviewed with your Quality Assurance team.
Before becoming a customer
of Rapid Micro Biosystems, our
team makes efforts to ensure
that your implementation of
the Growth Direct™ System
is successful.
As part of the pre-sale process,
the Rapid Micro Biosystems’
technical services team provides
the following services:
Figure 2. Enumeration accuracy, Growth Direct at 24hours compared to 3 day Petri plate count.
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Control Method CFU
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wth
Dire
ct C
FU
B. smithiiB. subtilisB. atropheus1:1
To verify the effect of stress on BI detection, a Bier vessel was used to perform a sub-lethal kill.
Figure 3, Recovery of stressed B subtilis sporesC o rre la t io n fo r In ju re d B . s u b til is
y = 1 .0 2 2 4 x + 0 .0 9 6 2R2 = 0 .9 9 3 2
0
1 0
2 0
3 0
4 0
5 0
6 0
7 0
8 0
0 1 0 2 0 3 0 4 0 5 0 6 0 7 0
V is u a l C F U c o u n t a t 3 - 5 d a y s
ntco
uec
t™ow
th D
ir24
hr G
r
8 0
Conclusion.
Return On Investment Development
Rapid Micro Biosystems will work with you on the development of a compelling ROI for justification of the Growth Direct™ System.
IT Support Services
As part of activities before your purchase of the Growth Direct™ System, the Rapid Micro Biosystems’ technical services team will work closely with your Information Technology group to facilitate the implementation of the specific required services.
The following are examples of the IT support:
Network Connectivity
To ensure a successful connection to the network the Growth Direct™ System has a dedicated menu page to enable the IT team to link the Growth Direct to the host network.
Bi-Directional LIMS Integration
The data on the Growth Direct™ System can be dropped to a number of different LIMS systems and other networked programs e.g. EM trending
databases. The Growth Direct™ System creates a standard export file in .xml or CSV format that can be parsed by the networked program to pull relevant data.
The Growth Direct™ System can be integrated to a LIMS system to enable bi-directional interface with the system software. Results can be retrieved from the operators desk terminal or sample test lists down loaded remotely to the system for analysis.
E-Mail Connectivity
The Growth Direct™ System can be set up to distribute emails to different people according to the data set. For OOS sample results the QC personnel can be contacted, for incubator temperature excursions the facilities person and for a system service issue the Rapid Micro Biosystems service team.
Remote Access
Rapid Micro Biosystems is able to work with the IT team to enable secure, remote access by the Rapid Micro Biosystems service team to monitor the system performance, anticipate problems and quickly resolve issues reducing downtime.
Training
Rapid Micro Biosystems offers of training to help your microbiology team quickly adopt the new technology. These sessions allow users to understand key concepts and uses of the Growth Direct™ System.
Validation Support
Rapid Micro Biosystems can provide a complete array of documents and services in the support of your validation of the Growth Direct™ System. This includes all the steps in the validation process, including:
Installation Qualification Operational Qualification21CFR11 assessmentPerformance QualificationMethod Suitability
Getting Started
Once you have decided to use the
Growth Direct™ System for your
microbial testing, the Rapid Micro
Biosystems’ Technical Services
team works directly with your
team to implement and validate
the technology bringing you to
production as quickly as possible.
The technical services team
holds regular conference calls
throughout the progress of
the project to promptly
resolve questions.
Some of the services performed
after the sale include:
Installation
The Rapid Micro Biosystems’ team will unpack and install the Growth Direct™ System at your site, ensuring IQ / OQ readiness.
Software integration to LIMS
Rapid Micro Biosystems will work with your information technology team and assist as needed in integration of the Growth Direct™ System with your laboratory information system (LIMS) for seamless connectivity.
The technology of the Growth Direct™ System uses infrastructure that is easily maintained by your businesses Information Technology team. Some of the key components are as follows:
Operating System
The Growth Direct™ System runs on Windows 7 operating system. When installed, the system has all relevant Microsoft updates included in the installed software releases. Each new Growth Direct™ System software release contains system and Microsoft 7 updates (interim Microsoft updates are not randomly uploaded to the system).
21 CFR 11 Compliance
The Growth Direct™ System software was designed to be compliant with the requirement of 21 CFR Part 11. Rapid Micro Biosystems can supply an assessment of the regulation and how the software addresses each requirement.
Antivirus packages
The Growth Direct™ System is compatible with the major antivirus packages available on the market. Rapid Micro Biosystems does not supply any antivirus package with the system.
Back up/Archive
The Growth Direct™ System is configurable for automatic back up frequency and can send the data to any directory required.
Disaster Recovery
The Growth Direct™ System can support a disaster recovery process through the use of either Ghost Images or the RAID configuration of the system.
Software Updates
Rapid Micro Biosystems expects to have a software release each year to address any corrective actions or to include new functionality. Rapid Micro Biosystems will supply full release notes and a requalification document if required.
Custom Report Development
Should you require specific reports that may not be available on the Growth Direct™ System, Rapid Micro Biosystems can develop those reports for you.
Ongoing Support
General Support
Rapid Micro Biosystems manages regularly scheduled conference calls with customers during their validation process. In addition, general questions are handled via phone 888-RAPID-07 or email [email protected]
Consumables Support
The Rapid Micro Biosystems team provides frontline support for questions regarding the proper use, quality and performance of the Growth Direct™ System consumables including:
Product issuesCertificate of Quality RequestsChange Requests
Preventive Maintenance
Twice a year, a Rapid Micro Biosystems representative will perform preventive maintenance activities on your Growth Direct™ System.
Interventions
Rapid Micro Biosystems’ Field Service Engineers are always on call and available to handle system issues for service and repairs. The Rapid Micro Biosystems goal is to complete system repairs within 24 hours of arrival on site.
Now that your Growth Direct™
System is operating in production;
the Rapid Micro Biosystems’
Technical Services team continues to
support your continued operations
through services such as the
following:
Support Options to Meet Your Business’ Needs
Rapid detection, improved efficiency, and reduced investigations are critical to your business’ success. Rapid Micro Bioystems’ Support Services deliver tailored services to help you maintain and maximize the performance of your Growth Direct™ System. Our engineers provide proactive and preventive support using advanced tools to help you ensure system availability, reduce risk, and accelerate ROI. Support includes preventive maintenance visits, upgrade support, training, and other critical services. Choose from different levels of support services that would best suit your business’ needs.
Testing Consumables
Level A Level B Level C
Number of Preventive Maintenance visits per year 2 2 2
Turnaround time on interventions 24 hours 48 hours 72 hours
Number of interventions included
All interventions covered
All interventions covered
All interventions covered
Upgrade supportSoftware upgrade + requalification
documents provided
Software upgrade + requalification
documents provided
Software upgrade provided
Training Basic system training Basic system training Basic system training
Applications support 2 weeks on site 1 week Not included
Incubator servicesIncubator Clean and
Annual Incubator Temperature Mapping
Rapid Micro Biosystems, Inc. One Oak Park Drive Bedford, MA 01730 USA T: 781-271-1444 F: 781-271-9905
Rapid Micro Biosystems Europe GmbH Lise-Meitner-Straße 30 85354 Freising/Weihenstephan, Germany
www.rapidmicrobio.com