We provide GxP Digital Manufacturing project and program support services in three main areas:

 1.  Strategic Planning

 2.  Project & Program Management

3.  Advisory, Training & Coaching

Strategic Planning

Strategic planning for GxP digital manufacturing requires knowledge of your business and regulatory challenges, broad applications expertise, a repeatable methodology, and unclouded objectivity. Our strategic planning offering takes the form of a Front End Study whereby we will assess how or if integrated digital applications can address your business challenges in the context of your existing and projected environment, specify which applications are the best fit, manage the specification of requirements, provide an integrated systems road map to meet your objectives, and generate experience based project plans. 

A key component of our strategic planning is the provision of a Return On Investment (ROI) model which can be used for decision support. This service can be extended to include full tender management and vendor appraisal for specific projects in the road map. 

Specific components of our Strategic Planning offering include:

  • Strategic information systems road map (current state & projected needs)
  • Consolidate business objectives
  • User Requirements Specification (business, regulatory, and technical requirements)
  • Total Cost of Ownership (mid & long term)
  • Return On Investment (decision support for project or solution justification)
  • Program Scheduling
  • Identify common risks and mitigation strategies

System selection components include:

  • Develop the Request For Proposal (RFP) documentation
  • Recommend or implement a tender management process
  • Provide a structured appraisal methodology
  • Review vendor proposals and presentations
  • Vendor quality audits
  • Short list recommendations
  • Final contract negotiation

Project & Program Management

Once the strategic vision and right solution components are identified, we provide independent project and program management to take the solution from vision to realization. We combine our "business returns" focus  with extensive projects experience, where every project step is assessed against business goals and realized through industry good practices, avoiding common pitfalls along the way. We work with the project team comprising the Life Sciences Companies own Subject Matter Experts, vendor software consultants, other suppliers, and a Steering Committee of key business and process decision makers. The make up of this team, along with roles, responsibilities, and effort is defined by Systematic at the planning stage and incorporated into the capital project costs if required. We can also help to build this team from scratch if required. Our repeatable project implementation template is based on the experience of many projects across multiple IT/OT application areas and technologies. When effective project management is combined with robust strategic planning and the right digital product(s), the result is a project delivered within time, cost, and scope (features), and meeting forecasted Return On Investment (ROI). The added regulatory and quality dimension is recognized through a project trail that is designed to facilitate regulatory audits. Our project management approach includes:

  • Project & Quality Plan development
  • Project alignment with strategic goals and objectives
  • Independent management of internal and vendor deliverables
  • Repeatable Project Management methodology/template aligned with industry good practices (GAMP & Regulatory expectations).
  • Budget management
  • Ongoing supplier contract management
  • Risk management
  • Verification/Qualification/Validation oversight
  • Computerized systems good practice training

Advisory, Training & Coaching

In cases where full Project Management is not required, we offer a Project Steering service which takes elements of the full PM offering and combines this with a project mentoring/coaching service. This is often applicable where there are internal experience gaps (in technology, compliance, or project management), or where new teams need experience based support.

We offer both standard (pre-packaged) and customized advisory, training, and coaching services. 

Common standardized training includes:

  • GAMP(R) good practice
  • Manufacturing Computerized Systems Regulations & Data Integrity
  • Integrated GxP Manufacturing Execution Systems
  • Digital Transformation in Life Sciences