Improve your processes for developingproduct o�erings

Infor CloudSuite™ Industrial (SyteLine) for Life Sciencesis built to speci�cally address the unique requirements ofthe life science industry. Created with The CopleyConsulting Group as part of Infor’s Micro-VerticalSpecialization Program, the solution delivers advancedsecurity, data auditability, electronic recording, andbusiness intelligence capabilities mandated for FDAcompliance. At the same time, Infor CloudSuite Industrialfor Life Sciences gives you the tools you need to helpyou mitigate compliance risk, while turning yourdevelopmental concepts into commercialized producto�erings with greater e�ciency.

Stay current with the shiftingstandards of FDA compliance

For life sciences manufacturers,

advancing and maintaining information

management solutions that are

compliant with an evolving set of FDA

regulatory standards is a constant

challenge. As you strive to manufacture

high-quality life sciences, you need

an enterprise resource planning (ERP)

solution that can help you minimize

compliance risk, as you maintain

pro�tability, drive e�ciencies, and

streamline all parts of your business.

Infor CloudSuite Industrial(SyteLine) for Life Sciences

Infor CloudSuite Industrial for Life Sciencesgives you the tools you need to develop,evolve, and thrive in a regulated environment.

Life Sciences

Previous state

Inability to identify improvements inmanufacturing processes

Time- and resource-consuming inspectionintrusive to manufacturing process

awide pool of stand-alone systems

Fragmented, hybrid compliance systems

Isolated functional units

Future state

Electronic records and visibility across allmanufacturing processes facilitate true

s

Real-time inspection

dsystems

Integrated compliance systems

Regulatory compliance enforced with eachquality system and integrated system-basedapproach to compliance

Meet regulatory requirementsInfor CloudSuite Industrial for Life Sciences is delivered in an FDA compliant IT infrastructure. It is deliveredwith well-established protocols and validation scripts developed by The Copley Consulting Group that meetregulatory requirements for computer systems in compliance with the FDA’s 21 CFR Part 11. The latest set of FDArules necessitates compliance from a systems-oriented approach, rather than isolated functional units.

Take a systems-oriented inspectionapproach to FDA compliance

Infor CloudSuite Industrial (SyteLine) for Life Sciences Brochure 2

Maintain regulatory complianceFor life sciences manufacturers, business process validation, inclusive of computer software, is a criticalcomponent of maintaining regulatory compliance. While validation ensures the software’s intended use issubstantiated and documented, this process can consume valuable resources, material costs, and expose acompany to the risk of FDA audit non-compliance if not properly executed. Here’s how Infor CloudSuite Industrialfor Life Sciences can help.

Kick-start the validation processThe operational validation scripts, developedspeci�cally for Infor CloudSuite Industrial for LifeSciences, can help manufacturers reduce the e�ort,resources, and risk it takes to meet these stringentrequirements. The proprietary protocols available toyou in Infor CloudSuite Industrial for Life Sciencesinclude scripts and best practice templates to help youkick-start and facilitate the validation process.

Use integrated electronic recordsGlobal regulatory agencies, including the FDA, de�neelectronic records as the information created, stored,generated, received, or communicated by electronicmeans. With electronic records management, thisinformation can be accurately perceived, reproduced,and distributed for further assessment. For lifesciences manufacturers, this information may beassociated with various object types for engineeringchange management, audit trails, device historyrecords (DHR), device master records (DMR), revisioncontrol, quality plans, and a range of other key areas ofinformation management that are associated with FDA compliance.

Infor CloudSuite Industrial for Life Sciencesprovides electronic records throughout the lifesciences manufacturing lifecycle from the creation ofdigital records through modi�cation, storage, andrecords submission to FDA. This information includesthe printed name of the signor, date, and time stamp,as well as the meaning associated with the signature.Extending the use of electronic signatures beyondspeci�c requirements of the FDA to meet industrystandard good manufacturing practices (GMP) furtherestablishes a win-win proposition for life sciencesmanufacturing organizations.

Uphold GMP quality standardsIne�ective enforcement of corrective and preventiveaction (CAPA) processes in fragmented compliancesystems often leads to non-conformance to FDAregulations. To enable FDA compliance, you mustintegrate CAPA results into the information systemsyou use for quality planning. This is critical to improvingmanufacturing processes and leveraging electronicdata recording and information managementcapabilities. Life sciences manufacturing companiesneed this business system functionality to contain costsand tighten product and process control.

Infor CloudSuite Industrial for Life Sciences givesyou the tools you need to integrate CAPA results intoquality planning, improvement, assurance, engineering,and control. That way you can create a centralizedapproach to master data management.

Infor CloudSuite Industrial (SyteLine) for Life Sciences Brochure 3

Copley Implementation Accelerator is a packagedset of well-de�ned deliverables that allow for thesuccessful deployment of Infor CloudSuiteIndustrial for Life Sciences on an aggressivetimeframe. Copley Implementation Acceleratorcan reduce the risk to your budget parametersand go-live expectations by increasing yourtechnology ROI and reducing the downtime foryour critical functions.

Sensitive to GMP practices, CopleyImplementation Accelerator enables us to deliversolutions tailored to your company’s uniquevalidation, quality, compliance, and regulatoryrequirements. The methodology optimizes yourresources and streamlines your implementationprocess, with the �exibility of deploying in thecloud or on-premise while ensuring the samehigh degree of success.

Go-live quickly with Copley Implementation AcceleratorCopley Implementation Accelerator makes it possible for life science manufacturers to implement InforCloudSuite Industrial for Life Sciences quickly and without major modi�cations, while still bene�ting from thesolution’s �exibility and scalability for long-term, continuous improvement.

Streamline the implementation process

Infor CloudSuite Industrial (SyteLine) for Life Sciences Brochure 4

Learn more about Infor’s solutions forlife science manufacturers.

Infor CloudSuite Industrial for Life Sciences isy

to address the nuances of a life scienceenterprise with:

Deep life science functionality

Packaged operational validation scripts

Industry knowledgeable consultants

Implementation Accelerator package

Regulatory compliance

sdangerous enough to manage. Controlling yourbusiness and conforming to strict regulationsshould not add to your challenges. With InforCloudSuite Industrial for Life Sciences, you canreduce these risks and make your business

.

Deploy a complete solution for life sciences manufacturersFrom managing complex value chains and product launches to shortening cycle times and easily

sbacked by decades of practical application and relied upon by thousands of manufacturing customers worldwide.

edeployment options, either through a subscription in the cloud or a traditional on-premise license option.

Reduce compliance risks andimprove your business

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