Audit trails play a crucial role in ensuring data integrity, traceability and compliance with Good Manufacturing Practice (GMP) regulations. Under the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16), Annex 11 outlines specific requirements for computerised systems, emphasising the need for audit trail reviews....
The International Society for Pharmaceutical Engineering (ISPE) is a global not-for-profit association serving its members involved across the entire pharmaceutical product lifecycle. Affiliates and Chapters of the ISPE can be found around the world.
ISPE India, the Indian affiliate of ISPE, recently invited SeerPharma's Director – Ian Lucas, to...
Computerised System Validation (CSV) is an activity carried out by Pharmaceutical and Medical Device organisations to ensure that IT infrastructure and applications that impact product quality are operating in a controlled state. Organisations must demonstrate an appropriate level of control of their Computer Systems to regulators such as the US...
If you work at a regulated company, then there is a fair chance that you have heard of the term computer system validation (CSV). The issue is that a “computer system” is technically the hardware and software of a platform system. Around that you need to add application software, ancillary equipment, people and procedures to form a “computerised...
Most of us follow a professional sporting team. Each year we start the season with hope and enthusiasm that ‘this year’ will be ‘our year’. Have our recruiters and management assembled the right mix of youth and experience and will they be coached to their strengths? Is the framework in place to raise our odds of success ?
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