Combining Automation, Validation, and Compliance Strategies for the Entire Facility
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Combining Automation, Validation, and Compliance Strategies for the Entire Facility
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| Segregated HVAC and Process Control | Integrated Disparate Control Platforms | Common cGMP Control Platforms |
Today's regulated facilities require the technology and implementation expertise to integrate various applications and functions into a single, cost effective automation strategy. This strategy is different for all facilities and clients depending on their unique requirements. GxP Automation has the experience and, with a portfolio of leading products, can assist our clients with determining and implementing the best strategy to fit their needs.......
Critical Environmental / HVAC / Utility Control:
The biotech and pharmaceutical industry have gone through some tremendous changes in the last 15 years with the advancement of automation technology. With the advancement of this technology, comes the ability to speed drug delivery to the general public. However, implementation of this technology has brought about operational and political shifts within the organizations to meet the expanded and more stringent FDA requirements. The most prevalent of these changes in the last 3-5 years has been in the area of environmental monitoring and control of cGMP/Validated production suites. Gone are the days when the facilities department can implement a standard building automation system serving a validated area without the scrutiny of those in charge of product production and validation; the same departments who are now held responsible for the entire facilities adherence to FDA regulations including the HVAC controls. To meet these demands, today’s strategies require merging HVAC control expertise implemented with procedures and/or product platforms historically designed for process control……Read More
Building Management, Lighting Control, Security, Card Access, CCTV
In the Life Science Industry, like all other industries, there are automation applications outside of the manufacturing process such as facility HVAC control, Utility Automation, Lighting Control, Security, Card Access, and CCTV. These applications require reliability, robustness, and leading technology to meet today's operational, integration, and financial demands.
Today, the industry is demanding products that have invested in current technologies and embraced the open architecture concept of BACnet that allows a facility or campus to utilize products from multiple vendors in the overall facility automation strategy. Rather than being locked into a single provider of a single product, this ensures the client of competitiveness in the open market and the ability to choose their automation partners based on service and capabilities.
Critical Equipment Monitoring:
The Life Science Industry can not afford to lose its most valuable asset, the research and development of new products…
Utilizing
a suite of world class, leading enterprise software solutions for the Life
Sciences Industry, GxP Automation has packaged the right solution for
monitoring, alarming, reporting of critical equipment and environmental
monitoring for GLP Laboratories and Vivariums. With this solution, our clients
can integrate all drug life cycle data, from research to manufacturing and
warehousing, into a single, secure archive.
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Today's automation and compliance technologies are evolving faster than the industry that designs and installs complex facilities. There is an evolving need for project resources who understand the new technologies and can add value by assisting in the complex design, selecting the right products to fit the solutions, provide associated regulated documentation, and providing "technology project management" from the start of the project to completion.
Unlike today's typical commissioning agents who find problems after the installation is complete, a technology project manager will prevent the problems from ever occurring.
GxP Automation has the complete turnkey automation experience to assist our clients in project design, construction management services, and technology implementation coordination. With our experience with the entire GLP/GMP facility construction process, we can offer our clients the opportunity to streamline the design and construction of the entire facility while preventing the common coordination inefficiencies, project delays, and associated cost overruns........(Back to Top)
Validation Services / 21 CFR Part 11 Compliance:
Today’s validation strategies for regulated facilities have encompassed far more than just the production equipment. Today, all departments and all systems are under constant scrutiny…..Read More
GxP Automation has the experience and expertise with both process and critical environmental/HVAC control validation. Along with the project requirements, we understand the departmental responsibilities that have emerged between Facilities, IT, QA, Research, and Validation departments and are prepared to assist our clients in meeting their company and regulatory objectives efficiently and cost effectively. (Back to Top)
Process Control and Integration:
Today’s emerging automation integration technology is changing rapidly. With the emerging political integration between production and facilities, this offers tremendous advantages for standardization, compliance, quality, and efficiency. This all equates to lower costs over the system life cycle…..Read More
Our extensive experience with critical HVAC automation combined with our integration philosophies provide our customers with the unique opportunity to provide common validated platforms for monitoring and/or control of all GMP/GLP systems. (Back to Top)