Terms of Reference


(In alphabetic order only)

Compliance

In a broad sense this includes regulatory compliance, operational compliance (SOX in the US), and others e.g. Federal Rules of Civil Procedure (FRCP) and healthcare compliance (ISO, ICH, FDA, EMA, OIG and PhARMA Guidelines)

Enterprise

The life science company including all domains and stakeholders

Effectiveness

A process (or system) is effective if it is meeting the business needs (process outcomes).  A tool may meet the key documented requirements but if no one will use it, it is not effective

Efficiency

A process (or system) is efficient if it increases the productivity of people overall.  Improving one task or characteristic of a process may have negative impact on another.  If the sum improves the overall good, then it provides efficiency

Global Life Sciences

All business in the Pharmaceutical, Biotech, Generics, Consumer Health Care and Medical Devices as well as the regional and national agencies that govern them

Stewardship and Governance

Clear responsibility and accountability for management, protection and use of vital information assets

Strategy

The long-term plan of action designed to achieve the Vision – The strategy may be adjusted based on operational experience, changes to the regulatory or technology landscapes, and/or new marketing challenges

Tactics

The detailed goals and step-by-step activities needed to execute the strategy, or some segment of the overall strategy. The planning must accommodate cultural realities, proposed changes, and the requirement to effectively continue to run the business

Visioning

Visioning is the process of defining where a company wants to be over a period of the next 5 to 7 years. Participants will create an image of the effective and efficient processes that are needed to transform the enterprise, with a focus of process outcome. The requirements for enabling operational systems that are needed to achieve the vision should be included.

Visualization

New approaches call for new enablers: In the process of creating the new horizon cutting edge technology will be engaged to help business users in a Proof-of-Concept (PoC) to visualize and understand what is possible today

XML Content

XML Content includes all text and any other content plus the corresponding tags. Subsequently, XML content may be compiled into documents and formatted according to layout for publishing and communication needs. Information is structured into elements of meaning (Information Units or topics in DITA. XML allows the identification (tagging) of that information for re-use. Information may be text, images, audio, video and possibly other forms (e.g. essence)