|
The Swift Call Pty Ltd Quality System embodies a set of procedures for carrying out Quality Processes and Activities, preservation of information supporting Quality Processes, and recording the results of Quality Activities compliant with GAMP4 and ISO 9000 principles.
GAMP4
The standards for Good Automated Manufacturing Practice (GAMP) came into being as a direct result of the increase in regulatory attention received by the pharmaceutical manufacturing industry, as automated systems became more complex and more widely used.
The GAMP forum was set up to promote better understanding and interpretation of the regulations and improve communication within the pharmaceutical industry, its suppliers and the various regulators. The GAMP forum is now a technical subcommittee of the International Society of Pharmaceutical Engineering (ISPE).
Swift has established processes to meet the latest GAMP4 requirements for Clinical Trial Management and computer system validation through:
- Planning and Definition - Validation Plan, User Requirements Specification and Risk Assessment
- Design and Development - Functional Design & Acceptance Test Specification for hardware & software
- Development Testing, System Build - Hardware & Software acceptance testing, Systems Integration and Design review
- Commissioning and Qualification - Installation and Operation qualification and Validation Report
- Ongoing Operation - Change Control, System Security, Backup and Recovery, Periodic review, Performance Monitoring
The design of the Swift Call computerised
IVRS system ensures that all applicable regulatory requirements
for record keeping and record retention in clinical trials
is met with the same degree of confidence as that provided
with paper systems, as mandated by the US FDA. In particular,
all data that is stored on electronic media has an audit trail
in accordance with 21 CFR 11.10(e) for full accountability.
|
