Pharmaceutical and Bio Tech Companies

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Expertise – CSI has two decades of experience working at many of the companies in the pharmaceutical and biotech industries. CSI 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. Example projects include identifying, managing and global implementation of corporate wide systems such as Electronic Quality Management Systems, ERP Systems, LIMS, Chromatography, CMMS, Contracts and Chargebacks Systems, Document Management Systems and many more.  CSI also provides discovery, gap analysis and guidance on Computer System Validation including Data Integrity compliance support and remediation. With the FDA requiring more focus on Data Integrity, our team can assist your organization in identifying gaps and assist in developing and executing a remediation plan.

Validation

Our team can assist in all types of validation activates ranging from creating SOP to execution of IQ’s, OQ’s and PQ’s.  Call us to discuss your specific needs.  

QMS/Document Management Implementation

Our team has experience with many of the industry leaders in QMS and Document Management. They are vendor neutral and can assist with: user/business requirements, vendor RFP and selection, implementation project management, validation and user training. 

Data Integrity

With the FDA putting more focus on Data Integrity in the coming year, our team can assist your organization in identifying gaps and assist in developing a remediation plan.  Call us to discuss your specific needs.   

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Security

CSI has 18 years of experience protecting and guarding corporate information.  We understand the growing concern over malware and virus threats as well as protecting your most important asset - your information and data!  We have helped hundreds of companies, small and large in size, assess, remediate and maintain a secure computing and data environment ensuring that your information is protected and available only to those authorized to view it. 

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CSI Managed IT Services

24 hours a day 7 days a week Computer Help Desk, remote and onsite support, monitoring of critical systems, offsite backup. We support PC’s, MAC’s, iPads, Android, Windows, etc.  

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Infrastructure Design and Support

We provide infrastructure design, upgrades, support and deployments. Our infrastructure architects can design a local, wide area and wireless network to support your business applications.  The business applications will only run as good as your network will allow.  CSI can assess your current infrastructure and recommend improvements to make it more secure, robust and reliable.

Project Management

Our project managers do not just manage projects, but assist in all phases of the project. Beginning with the defining of business requirements all the way through to the training and deployment. They can assist in the complete RFP process and will always remain vendor neutral. 

Disaster Recovery planning and implementation

We provide Disaster Recovery planning and implementation services to insure that your information is guarded against various disasters and that it is recoverable and accessible in the event of a disaster.

Mergers/Acquisitions/Divestitures

Auditing Services – Identify Synergies – Contract Terms Review, Identify Redundant Services – People / Systems / Applications, Merge email / Networks and other critical systems, Integration Services – Applications / SOP’s / Processes 

IT 360

Helping IT align with Business Goals.  Total Assessment and Security Analysis Services including People, Processes and Systems.  Utilizing IT 360, CSI performs and extensive assessment of the current IT processes investigating all components and every aspect of the IT operation from security and data integrity to monitoring systems and staffing.  This in-depth look at the company’s business processes allows for a complete assessment of their environment and business unit/system support operations. 

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Business Process Mapping

Mapping the processes in the current business provides a simple and effective way to identify opportunities for improving efficiency and effectiveness. Process mapping also provides a great springboard to simplify and speed up decision making and encourage everyone in each team to contribute to growing the company. 

Regulatory Expertise

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CSI has provided IT support in a regulated environment for the past 20 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: 

  1. 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.
  2. 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.  
  3. Startup Pharmaceutical Developed Computer Systems Validation Policy, SOP’s and templates for Protocols, Validation Plan, IQ/OQ/PQ, User Requirements and traceability matrix.
  4. Validated existing infrastructure and developed Policies and SOP’s for System Security, Backup and Restore, User/System Access, Computer Usage and System Administration.
  5. Implemented a eQMS system.  Developed and executed all aspects of Validation and Training.
  6. Developed eQMS SOP’s and Work Instructions (Document Management, Change Control, Deviation, OOS and CAPA).
  7. Completed a Data Integrity Assessment and remediation plan on existing Lab Computer Systems.  Developed SOP’s for operation and maintenance of laboratory systems.

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CIO and CTO Services

CSI offers contract experienced CIO and CTO services. Our clients know they can rely on us for expert technology strategy steering, management, project services, M&A discovery, planning and assessments.  

Outsourcing and Staffing

CSI provides experienced professionals for short-term projects, long-term engagements and for permanent placement. This flexibility is the key to successfully matching the proper resource with each specific requirement. CSI’s professional recruiters consistently deliver resources to supplement our client’s needs within their time and budget constraints.  

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Telephone System Implementation, Migration and Management

CSI can implement any of the latest VoIP technology telephone systems that are integrated with Office 365 and other core communication standards.  We provide the right system for your business based on your specific needs.  We can even provide a hybrid system that utilizes the equipment that you have already invested in.