Job 14290: 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. Classification: Procedures for existing processes Completed May 2003

Job 14284: HCi developed quality system software qualification documentation for a major pharamceutical company. This documentation was designed to meet the requirements of their quality system and the Therapeutic Goods Administartion (TGA). Classification: Software operations (not user) procedures Completed Jun 2003

Job 14265: An HCi technical writer documented new procedures identified by an internal compiance audit for a major phamaceutical company. Classification: Procedures for new processes Completed Sep 2003

Job 14213: The client is a health care provider of diagnosis and treatment for sufferers of serious illness. HCi 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. Classification: QA consulting report, Procedures for new processes, Procedures for existing processes, Privacy audit, Training Completed Jul 2003

Job 14193: 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 HCi 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. Classification: Software user documentation, Software system description, Hardware user documentation Completed May 2003

Job 14179: We provided a writer to develop user documentation for image analysis software for use in a biotechnology environment: specifically, analysis of stained samples from electrophoresis. Classification: Software user documentation Completed Dec 2002

Job 14137: A major manufacturer of pharmaceuticals recognised the need to upgrade its current Sales policy and procedures manual. It asked HCi to carry out an analysis and make recommendations for improvement. HCi 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. HCi 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. Classification: Procedures for existing processes Completed Nov 2002

Job 14135: A large Biotechnology company marketing a suite of laboratory reseach instrumentation approached HCi to assist them in developing validation documentation to satisfy the requirements of the FDA in the USA. Classification: Hardware systems documentation Completed Sep 2002

Job 14101: A leading 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. Classification: QA consulting report Completed Aug 2002

Job 14075: A new biotech company needed a process developed for planning the installation of a complex package of scientific equipment and software. We facilitated the development of this process and documented it so that staff could be trained. Classification: Procedures for new processes Completed May 2002

Job 14061: Produced a user guide for a dial-up connection application developed by a large health care company for use by their staff to connect to the company's network from their home PC. The application ran on a range of Microsoft Windows operating systems and this had to be addressed in the documentation. The resulting documentation was generated as a single HTML file, along with relevant graphics, and had to be small enough to fit on a floppy diskette with the Dialler software. Classification: Software user documentation Completed Aug 2002

Job 14025: The amendments to the Federal Privacy Act had a major impact on this client, which is a non-profit organisation providing education services for children with hearing and/or vision impairments. The data collection performed by the organisation, both for service provision and fundraising, meant that all of their activities had a potential risk of failing to comply with the privacy rules. The organisation asked HCi to review its activities against the privacy legislation, and determine the actions needed to address the new requirements. We completed the gap analysis, and then wrote documentation to provide privacy guidelines for all staff. We also provided a structure for ongoing documentation and compliance management. Classification: Document management consulting report Completed Jul 2002

Job 14015: A large biotechnology company marketing a suite of laboratory research instrumentation approached HCi to assist them in developing training documentation to enable them to provide training for new users of their instruments. Classification: Training materials Completed Sep 2002

Job 12784: 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. Classification: Hardware user documentation Completed Dec 2002