Case study
Software for respiratory research
Our client, a leader in respiratory research, developed a range of instruments to record patient inhalation data. To meet a challenging schedule, they turned to Sagentia to develop software to control the instruments and meet demanding regulatory requirements.
Our client is a leader in respiratory, anti-viral and central nervous system research of clinical trials to ensure all new drugs meet strict regulatory requirements. In order to trial respiratory therapeutics, the company had developed a range of sophisticated instruments to record data on patient inhalation, and collect data during field trials for study within a controlled laboratory environment. To meet a challenging development schedule, the company needed to find a partner capable of designing and developing the software to control the instruments during research.
By outsourcing its software requirements to Sagentia, the company was able to tap into a rare combination of pharmaceutical and software expertise. The resulting system met a wide range of demanding development criteria, such as:
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FDA regulatory compliance, in particular 21 CFR Part 11 – the Electronic Data Rule
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relevant EC and US GMP requirements for computerised systems
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ease of use and minimal risk of misuse
A prototype system first enabled key users to test the software before the final design was confirmed. This created extra confidence in the final software, and made sure the design met the needs of those who would operate the system in the field.
Software development passed smoothly through each validation stage, and we met every project milestone. The final software was delivered on time together with full source documentation on CD.
Our client then asked Eutech, a leading specialist validation consultancy, to validate the completed systems. Following a rigorous final assessment stage, Eutech commented that the validation process was significantly streamlined by our approach.
Since the initial release of the software, we have continued to work in partnership with our client to further improve the system’s capabilities, and to enable its integration within the client’s corporate data repository.
Outsourcing can be a highly efficient means of ensuring the fast development of a complex project, especially if essential core skills are not available in house. We have a track record in providing outsourced services, and as a result we know we can use both technical and business expertise to allow the swift delivery of relevant and technically robust solutions.