Infor CloudSuite Industrial (SyteLine) for Life Sciences

Transcription

1 Life Science Infor CloudSuite Indutrial (SyteLine) for Life Science Stay current with the hifting tandard of FDA compliance For life cience manufacturer, advancing and maintaining information management olution that are compliant with an evolving et of FDA regulatory tandard i a contant challenge. A you trive to manufacture high-quality life cience, you need an enterprie reource planning (ERP) olution that can help you minimize Improve your procee for developing product offering Infor CloudSuite Indutrial (SyteLine) for Life Science i built to pecifically addre the unique requirement of the life cience indutry. Created with The Copley Conulting Group a part of Infor Micro-Vertical Specialization Program, the olution deliver advanced ecurity, data auditability, electronic recording, and buine intelligence capabilitie mandated for FDA compliance. At the ame time, Infor CloudSuite Indutrial for Life Science give you the tool you need to help you mitigate compliance rik, while turning your developmental concept into commercialized product offering with greater efficiency. compliance rik, a you maintain profitability, drive efficiencie, and treamline all part of your buine. Infor CloudSuite Indutrial for Life Science give you the tool you need to develop, evolve, and thrive in a regulated environment.

2 Meet regulatory requirement Infor CloudSuite Indutrial for Life Science i delivered in an FDA compliant IT infratructure. It i delivered with well-etablihed protocol and validation cript developed by The Copley Conulting Group that meet regulatory requirement for computer ytem in compliance with the FDA 21 CFR Part 11. The latet et of FDA rule neceitate compliance from a ytem-oriented approach, rather than iolated functional unit. Take a ytem-oriented inpection approach to FDA compliance Previou tate Inability to identify improvement in manufacturing procee Time- and reource-conuming inpection intruive to manufacturing proce wide pool of tand-alone ytem Fragmented, hybrid compliance ytem Iolated functional unit a Future tate Electronic record and viibility acro all manufacturing procee facilitate true Real-time inpection ytem Integrated compliance ytem Regulatory compliance enforced with each quality ytem and integrated ytem-baed approach to compliance d Infor CloudSuite Indutrial (SyteLine) for Life Science Brochure 2

3 Maintain regulatory compliance For life cience manufacturer, buine proce validation, incluive of computer oftware, i a critical component of maintaining regulatory compliance. While validation enure the oftware intended ue i ubtantiated and documented, thi proce can conume valuable reource, material cot, and expoe a company to the rik of FDA audit non-compliance if not properly executed. Here how Infor CloudSuite Indutrial for Life Science can help. Kick-tart the validation proce The operational validation cript, developed pecifically for Infor CloudSuite Indutrial for Life Science, can help manufacturer reduce the effort, reource, and rik it take to meet thee tringent requirement. The proprietary protocol available to you in Infor CloudSuite Indutrial for Life Science include cript and bet practice template to help you kick-tart and facilitate the validation proce. Ue integrated electronic record Global regulatory agencie, including the FDA, define electronic record a the information created, tored, generated, received, or communicated by electronic mean. With electronic record management, thi information can be accurately perceived, reproduced, and ditributed for further aement. For life cience manufacturer, thi information may be aociated with variou object type for engineering change management, audit trail, device hitory record (DHR), device mater record (DMR), reviion control, quality plan, and a range of other key area of information management that are aociated with FDA compliance. Infor CloudSuite Indutrial for Life Science provide electronic record throughout the life cience manufacturing lifecycle from the creation of digital record through modification, torage, and record ubmiion to FDA. Thi information include the printed name of the ignor, date, and time tamp, a well a the meaning aociated with the ignature. Extending the ue of electronic ignature beyond pecific requirement of the FDA to meet indutry tandard good manufacturing practice (GMP) further etablihe a win-win propoition for life cience manufacturing organization. Uphold GMP quality tandard Ineffective enforcement of corrective and preventive action (CAPA) procee in fragmented compliance ytem often lead to non-conformance to FDA regulation. To enable FDA compliance, you mut integrate CAPA reult into the information ytem you ue for quality planning. Thi i critical to improving manufacturing procee and leveraging electronic data recording and information management capabilitie. Life cience manufacturing companie need thi buine ytem functionality to contain cot and tighten product and proce control. Infor CloudSuite Indutrial for Life Science give you the tool you need to integrate CAPA reult into quality planning, improvement, aurance, engineering, and control. That way you can create a centralized approach to mater data management. Infor CloudSuite Indutrial (SyteLine) for Life Science Brochure 3

4 Go-live quickly with Copley Implementation Accelerator Copley Implementation Accelerator make it poible for life cience manufacturer to implement Infor CloudSuite Indutrial for Life Science quickly and without major modification, while till benefiting from the olution flexibility and calability for long-term, continuou improvement. Streamline the implementation proce Copley Implementation Accelerator i a packaged et of well-defined deliverable that allow for the ucceful deployment of Infor CloudSuite Indutrial for Life Science on an aggreive timeframe. Copley Implementation Accelerator can reduce the rik to your budget parameter and go-live expectation by increaing your technology ROI and reducing the downtime for your critical function. Senitive to GMP practice, Copley Implementation Accelerator enable u to deliver olution tailored to your company unique validation, quality, compliance, and regulatory requirement. The methodology optimize your reource and treamline your implementation proce, with the flexibility of deploying in the cloud or on-premie while enuring the ame high degree of ucce. Infor CloudSuite Indutrial (SyteLine) for Life Science Brochure 4

5 Deploy a complete olution for life cience manufacturer From managing complex value chain and product launche to hortening cycle time and eaily backed by decade of practical application and relied upon by thouand of manufacturing cutomer worldwide. e deployment option, either through a ubcription in the cloud or a traditional on-premie licene option. Reduce compliance rik and improve your buine Infor CloudSuite Indutrial for Life Science i to addre the nuance of a life cience enterprie with: Deep life cience functionality Packaged operational validation cript Indutry knowledgeable conultant Implementation Accelerator package Regulatory compliance y dangerou enough to manage. Controlling your buine and conforming to trict regulation hould not add to your challenge. With Infor CloudSuite Indutrial for Life Science, you can reduce thee rik and make your buine. Learn more about Infor olution for life cience manufacturer. Share thi : Copyright 2017 Infor. All right reerved. The word and deign mark et forth herein are trademark and/or regitered trademark of Infor and/or related a ate and ubidiarie. All other trademark lited herein are the property of their repective owner Avenue of the America, New York, NY INF en-US