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 21, 2021 | Management, GDP, MHRA, Responsible Person, Training, Warehouse
An effective Quality Management System is essential for ensuring that your operations are GDP compliant. What is a Quality Management System? Your Quality Management System (QMS) will lay out everything that you need to do and includes all procedures, processes,...
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...
by Paradigm Shift Consulting | Jan 31, 2020 | Inspection, Auditing, GDP, Management, MHRA, Responsible Person, RPi, Training
Self-Inspection and Third-Party Audits are an important part of maintaining compliance throughout the company. During a self-inspection you should find any deviations or failures within your operations, and from there you can start to make improvements to your...
by Paradigm Shift Consulting | Jan 7, 2020 | Inspection, Auditing, Documentation, GDP, GMP, Licensing, Management, MHRA, Responsible Person, RPi
MHRA inspection – Be Ready! So what does this mean? MHRA inspection Preparation is important especially if you are worried about non-compliance. Carry out a self-inspection and compare your operations against the guidance, to ensure that you are compliant (at...
