About CSI

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CSI is a 25 year old privately held consulting firm based in Parsippany, New Jersey with a satellite office in Naples, Florida. We provide computer system technology consulting services globally to small and mid-sized companies in all industries.  Our Pharma  group specializes on Pharma, Biotech and Healthcare businesses and can also provide discovery, gap analysis and guidance on Computer System Validation including Data Integrity compliance support and remediation.  CSI has two decades of experience working at many of the companies in the pharmaceutical and biotech industries and has delivered various technology projects at US startups that are bootstrapping themselves into operation and at large and medium size organizations that have a global footprint.   As a strategic consulting firm, CSI provides technology solutions that align with your business goals.  We outfit your business with the right technology tools to help your team reach their goals.

CSI is a leading provider of infrastructure design and deployment as well as managed services for IT infrastructure including active directory design, messaging & collaboration, database design & analysis, CRM, ERP and support services. It also provides business application analysis, implementation and support services as well as validation and process management.

CSI positions itself as a “trusted business partner” who is committed to the success of its client’s business. The company wants long term relationships with clients who call on the company when needed. When performing its work, CSI approaches IT with a 'Business Management mindset', aiming to exactly align a company's business goals with a set of best-fit IT solutions. Finding and successfully implementing these best-fit IT solutions is one of the biggest challenges in industry today. CSI recognizes that IT departments today, more than ever before, must add value by effectively helping the business achieve its goals and objectives. CSI supports these efforts by working to ensure that systems and technology always directly align with and support the business drivers. A case in point is the situation where a client selects a technology upgrade program of leading-edge products in order to demonstrate to its customers that the client is a progressive organization with the skills and organization needed to effectively utilize new tools.  

CSI has assembled a broad set of services and competencies that span business infrastructure, software, support, communication, security, project management and systems developers. CSI’s solution areas include:

• Active Directory Design and Implementation, Electronic Mail Systems, security systems and prevention
• Network Security, Network Infrastructure 
• Validation, compliance and Data Integrity services
• Business System implementation, project management, support

Whether you are implementing an IT initiative, IT consolidation or integrating new technologies, CSI offers a variety of solutions and support services to assist in design, development, and implementation. These successfully deployed and managed services will result in greater end-user satisfaction and an optimization of your IT infrastructure resources.

o We are on-hand with the necessary skilled resources to quickly and efficiently address mission-critical technical issues.

o Our comprehensive services encompass a number of critical aspects of your IT infrastructure including architecture, security, messaging, collaboration, disaster recovery, and migration planning. 

o We integrate services and best-in-class products into our suite of offerings to implement security, connectivity, and customized process definition, followed by full support. 

o Our methodology combines process, people, and technology to seamlessly implement innovative solutions into your IT environment. Our processes have been refined over a period of years to eliminate start up and cutover issues, and to proactively manage your network in the most efficient manner.

CSI has more than a decade of experience working at many of the largest companies in the pharmaceutical industry. The company has delivered large infrastructure projects at large and medium size organizations that have global IT networks and at US startups of foreign companies that are bootstrapping themselves into operation. Typically, a business event, such as a merger or acquisition, prompts the need to relocate and overhaul the company’s infrastructure. In support of these significant business events, CSI’s responsibilities has had to do everything from Overall Project Management of a multi-country infrastructure complete make-over, down to actually performing task-level activities at the network and cable level. CSI has provided services for pharmaceutical companies such as Actavis, IAVI, Alpharma, Amerigen, Keryx, Pliva, Prolong, Wockhardt and Enzon, to name a few. The company thoroughly understands the business and cultural requirements these pharmaceutical companies have and what they expect when they contract for services with organizations like yours.  

CSI has provided IT support in a regulated environment for the past 25 years. The majority of our clients are in a Pharma or Biotech regulated environment or in a SEC or other regulatory body environment. Some examples of our work in these regulatory environments are:

• Implementation of eQMS system at a Global Pharmaceutical Company.  Validated eQMS system in accordance with existing Validation Policy and SOP’s.  Created Standard Operating Procedures for use of System.  Created and Conducted Training material for use of system.
• Implementation of Nutanix System at mid-sized Pharmaceutical Company.  Developed and executed Validation Master Plan, Protocols and IQ/OQ/PQ documents in      accordance with existing Validation Policy and SOP’s.  
• Startup Pharmaceutical
  • Developed Computer Systems Validation Policy, SOP’s and templates       for Protocols, Validation Plan, IQ/OQ/PQ, User Requirements and traceability matrix
  • Validated existing infrastructure and developed Policies and SOP’s for System Security, Backup and Restore, User/System Access, Computer Usage and System Administration
  • Implemented a eQMS system.  Developed and executed all aspects of Validation and Training
  • Developed eQMS SOP’s and Work Instructions (Document Management,       Change Control, Deviation, OOS and CAPA)
  • Completed a Data Integrity Assessment and remediation plan on existing Lab Computer Systems.  Developed SOP’s for operation and maintenance of laboratory systems

The CSI methodology combines process, people, and technology to seamlessly implement innovative solutions into your IT environment. Our processes have been refined over a period of years to eliminate start up and cutover issues, and to proactively manage your network in the most efficient manner.

Using best of breed technologies and hardware, we take our knowledge and experience from the enterprise and apply it to the small and medium business in a scaled down version. This gives our non-enterprise clients, enterprise levels of service and support.