Project 14284 completed 2003: Realisation developed quality system software qualification documentation for a pharamceutical company. This documentation was designed to meet the requirements of their quality system and the Therapeutic Goods Administration (TGA).

Project 14290 completed 2003: Our client had a requirement to comply with both local GMP requirements and US FDA requirements for operational support in an IT area. We led a workshop to identify the documentation and compliance needs for their area.

Project 14213 completed 2003: The client is a health care provider of diagnosis and treatment for sufferers of serious illness. Realisation worked with the client to assist it to upgrade its operational and policy structures. Specifically, we - reviewed their current processes to determine what needs to be done to comply with Quality System Standard ISO 9001:2000, the Privacy Act and the Australian Quality Training Framework (AQTF) - created a system of documentation to address these compliance needs, and - trained staff how to maintain and manage the systems set up.

Project 14193 completed 2003: A new Australian company was developing an innovative clinical diagnostic tool and required closely focussed user documentation to support the sales and use of the product worldwide. The company approached Realisation who planned the development of a user manual aimed at a specific target user audience. The document was produced and was supported by an on-line help version and an attractive wall chart. The project was completed on schedule and on budget and provided a powerful tool in gaining user acceptance.

Project 14137 completed 2002: A pharmaceutical manufacturer recognised the need to upgrade its current Sales policy and procedures manual. It asked Realisation to carry out an analysis and make recommendations for improvement. Realisation planned and documented the new sales policy and procedure manual, which included a review of existing procedures, identification of procedures required but not documented, and a protocol for future development of all sales assistance materials. Realisation then wrote the procedures, which were incorporated into the new sales manual. The primary aim of this project was to deliver an updated, professionally written Sales manual which addressed various concepts in a simple & readable style.

Project 14135 completed 2002: A biotechnology company marketing a suite of laboratory reseach instrumentation approached Realisation to assist them in developing validation documentation to satisfy the requirements of the FDA in the USA.

Project 14101 completed 2002: A specialist heath care Institute asked us to do a complete review of their documented management systems to assess their effectiveness and check for compliance with the Privacy Act and ISO 9000. We completed a detailed report and, along with specific recommendations for improvement, we specified how best to deliver this knowledge via their intranet.

Project 14016 completed 2002: Our client was a semi-government health/transport organisation which used a wide variety of policy and procedure documents, instructional circulars, forms and other performance assistance material for its officers. It asked Realisation to analyse this material and make recommendations about improvements for the future. The project addressed both gaps and problems with the existing documentation. It planned how to populate the organisation's proposed Intranet with useful and up-to-date documentation to help to justify current and future investment in computers and network structures. The documentation proposed to allow operations and support staff to have clear, up to date and accessible instructional materials to enable them to perform their jobs. This would also allow the organisation itself to increase accountability, because audit against written procedures is more meaningful where those procedures are reliable. The plan scoped out how to deliver a series of online manuals suitable for various staff groups. Each was designed to provide relevant material for that group. A large proportion of the proposed manuals will consist of material in the current SOPs, upgraded and simplified to be more user-friendly and accessible for staff.

Project 14015 completed 2002: A biotechnology startup company marketing a suite of laboratory research instrumentation approached Realisation to assist them in developing training documentation to enable them to provide training for new users of their instruments.

Project 12784 completed 2002: Our client designed and manufactured a proteomics platform - a set of scientific instruments used for the analysis of proteins for the biotechnology industry. This involved a number of machines including a robotic sample processing system, a mass spectrometer and a centralised IT system to ensure that all of these worked together. We developed a documentation strategy for the platform, wrote the user manuals and training materials. We also provided consulting on compliance management.