Terms of Reference
(In alphabetic order only)
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)
Components (part of Structured Component Management [SCM])
Information is structured into elements of meaning (Data/Information Units or topics). Components may include all type of text and any other content plus the corresponding tags. Subsequently, components may be compiled into documents and formatted according to layout for publishing and communication needs: Substantial re-use opportunities. Data/ Information may be text, images, audio, video and possibly other forms (e.g. essence).
The life science company including all domains and stakeholders
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
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 data assets
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
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 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.
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 measurable Proof-of-Value (PoV) to visualize and understand what is possible today to generate a relevant Business Case (BC).