Congratulations on a fantastic site!!!
I just setting out in QA and currently I am supporting a project involving WDA(H) licencing for a meds packing unit in a remote site but for an NHS Trust. The computerised system is ‘‘off the shelf’’, standard compliant equipment and we have followed the Trusts URS. We are using ipads to record batch numbers and for audits etc. I need to ensure compliance with the regulations of MHRA but just not clear how to document the CSV in this case. Can I use a risk assessment approach and forgo the meed for a validation protocol, report etc… I can obtain ISO certificates from the suppliers, and include a Computerised System FMEA as part of the quality risk assessment. Will this be enough? Our computer system will not be used to control equipment that may have an impact on product quality as such as it is a GDP environment. The system is needed to record data, BN, Exp, record keeping, comms, placing orders, generating documents etc…
Thank you in advance for any time and consideration paid to answering this general query.