IS Compliance as a Service

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Business & Decision Life Sciences provide clients with a customized Information Systems Compliance as a Service, to provide the advantages of resource pooling, rapid flexibility, quality and cost effectiveness that is now demanded by regulated companies.

It is increasing difficult for regulated companies to maintain sufficient numbers of appropriately qualified, educated or experienced full-time IS compliance staff. It is also increasingly challenging for life sciences companies to stay up-to-date with respect to current IS Compliance regulations, guidelines and best practices. For many the 'solution' has been to work with general IT staffing agencies to hire contract staff or with generalist IT service providers under preferred purchasing arrangements. This often results in a situation where the quality of work is disappointing, activities take longer than planned and costs therefore increase and there is little or no access to real subject matter expertise.

IS Compliance as a Service from Business & Decision Life Sciences

To address this issue Business & Decision Life Sciences has developed a Service Level Agreement (SLA) to provision Information Systems Compliance as a Service (IS CaaS). This allows regulated companies to leverage the thought leadership and experience of one of the industries leading IS Compliance consultancies and to benefit from the resource pooling and rapid flexibility of resources that is an inherent part of such an SLA.

IS CaaS is more than just 'body-shopping'. The model provides the necessary subject matter expertise and resources that regulated companies require on a flexible basis. Leveraging Business & Decision Life Sciences RightDelivery® Global Delivery Model, it is possible to access both strategic and tactical staff on an as-needed basis without the overhead of maintaining a large IS Quality department. The model is ideal for large life sciences organisations wishing to focus on core business and for small-to-medium life sciences organisations who may lack the necessary subject matter expertise to comply with current regulatory expectations.

IS Compliance as a Service provides sustainable, cost effective and high quality IS Compliance, achieved through partnership with real subject matter experts.

The model and each SLA consists of three components:

  • Ongoing day-to-day IS Compliance activities
  • Strategic consulting and project related activities
  • Service level metrics and reporting


On-Going IS Compliance

Included at an agreed fixed cost and usually delivered by Senior Consultants or Consultants, day-to-day IS Compliance activities which can be included in the SLA could be:

  • Periodic reviews of IS processes, reviewing the qualified state of infrastructure platforms or the validated state of software applications
  • On-going IS compliance support for day-to-day IT activities such as Service Desk, Incident Management, Problem Management and Repair processes
  • Support for key IS Compliance processes such as Change Control and CAPA
  • On-going supplier surveillance audits

This may be provisioned on-premise, or to minimze the cost of such activities these services may also be conducted off-site or where appropriate, offshore.

Strategic Consulting & Projects

Based upon standard rates, agreed terms and conditions and with agreed service levels, Business & Decision Life Sciences are able to provision the right resource for the right role. This could be:

  • Part-time use of a Principal Consultant's experience and thought leadership to assist with e.g. a compliant cloud computing strategy or guidance on how to validate software for use with mobile computer platforms
  • Part-time use of a Senior Consultant to review key project documents such as Validation Plans, Test Strategies and Validation Reports
  • Initial supplier audits (supporting client audits, or as Lead Auditors) or package assessments
  • Full-time, short-term use of a Senior Consultant to develop or update IS policies and SOPs
  • Full-time, medium-term use of a small team of consultants to support the qualification of a new data centre or the validation of a new ERP, CRM, LIMS or MES

These activities may also be conducted on-site, off-site or offshore as appropriate

Metrics & Reporting

Although every IS CaaS agreement is based upon a standard model the specific roles and responsibilities and corresponding SLA are unique to the individual client. A Client Services Manager is appointed for every agreement and for each service under the agreement:

  • Service level metrics are defined and agreed
  • Service level metrics are monitored by the Client Services Manager
  • Monthly or quarterly SLA reports are issued and reviewed with the client
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