by Paradigm Shift Consulting | Jul 14, 2025 | Auditing, Change Control, Documentation, GDP, Inspection, MHRA, Responsible Person, RPi
Producing an Audit Report: What Happens Next Once you have planned and performed a first party (internal) or second party (external) audit, it is imperative that you document your findings in a formal audit report. Regulatory inspectors expect a ‘show and tell’...
by Paradigm Shift Consulting | Jul 6, 2023 | Training, Data, Documentation, GDP
Why is Data Integrity Training important? How we generate, maintain and store records, particularly paper and electronic mediums now and in the future is extremely important. Maintaining Data Integrity by having bonafide Data Integrity Training, forms part of your...
by Paradigm Shift Consulting | Jul 6, 2023 | GDP, Deviations, Documentation, Falsified Medicines Training, Responsible Person, Training, Warehouse
The packaging looks a little different. So what? Falsified Medicinal Products are a constant presence in the supply chain, and could be a serious threat to your health. With many people feeling the squeeze of the economy now, the urge to get quick and cheap medicines...
by Paradigm Shift Consulting | Feb 4, 2021 | Documentation, Data, GDP, Management, MHRA, Responsible Person, RPi, Training
Good Documentation Practice Documentation such as Standard Operating Procedures (SOPs) and records, are a crucial part of an effective Quality Management System (QMS). They make up all procedures, processes and evidence required for you to ensure that you’re in...
by Paradigm Shift Consulting | Jan 6, 2021 | GDP, Change Control, Data, Deviations, Documentation, Management, Responsible Person, Temperature Management, Training, Warehouse
What are Standard Operating Procedures? Standard Operating Procedures (SOPs) are the documents that will set out all of the procedures used by your company, meaning they should mirror these processes. They are the backbone of your company’s Quality Management...
by Paradigm Shift Consulting | Jun 24, 2020 | Change Control, Deviations, Documentation, GDP, Management, Non-Conformance, Responsible Person, RPi, Training
Change Control Processes A Change Control process will always need to be performed when changes are made to a system, piece of equipment or product. The process must ensure that all changes are identified, planned and implemented in a way that’s regulated and...
