As we have already stated, an effective URS will consider the following:

• Clear and adequate definitions of what the user wants the system to do ;
• References to all cGMP (or equivalent) regulations ;
• Timelines and milestones ;
• Corporate strategies and other ancillary items (as applicable) ;
• Any other regulations or guidelines applicable to the system (e.g., wiring rules) .

The general grouping of all of the above would be under either "Process User Requirements" or "General User Requirements".

It is suggested that each section have its own sign-off to allow for an asynchronous update cycle.

This type of data include any requirements that cover areas that can have an impact on the product or the process quality. The areas outlined under Process User Requirements would include items such as sterility, purity and any other area as identified by a risk-based assessment. The Process User Requirements are traced through the Design Qualification process to be verified as present in the final design.

A list of potential sub-sections under the banner of Process User Requirements could be:

• Critical Process Parameters - quantitative parameters including limits/range/engineering units; qualitative parameters;
• Critical Environmental Conditions - temperature, humidity, ISO room classification;
• Critical Quality Attributes - acceptable levels of contaminants, sources of contaminants, other quantitative acceptance criteria (including limits/range/engineering units);
• Product Utilisation - known products being made by the process or machine in question;
• Materials of Construction;
• Materials of Product Contact - discuss materials that have direct product contact and indirect product contact;
• Utilities;
• Instrumentation;
• Control System - hardware, software, security, data collection;
• Cleaning and Sterilisation;
• Other - as required.

These requirements are non-GMP relevant criteria. The include items such as wiring regulations, voltage etc. It would typically be a good idea to present as many of these items as possible in a generic standardised format as a separate document as part of your general procurement process. Minimal coverage specific to the system (or in the generic document) should include:

• Physical Requirements;
• Changeover;
• Acceptable Control System Vendor - HMI, SCADA, DCS, PAC, PLC etc. With detailed discussion on programming standards, HMI screen function standards etc. (as noted these are well suited to a generic procurement guide that can be prepared for you against any vendor you prefer);
• Environmental Requirements - include applicable regulations and reference;
• Health and Safety Requirements - include items here such as machine guarding, process/machine emergency stop requirements (i.e., SIL or category level), ergonomics etc. Always include all applicable regulations against guarding, pressure vessels etc.;
• Factory Acceptance Test - list all expectations;
• Site Acceptance Test - list all expectations;
• Vendor Requirements - list all items under the vendors' purview;
• Documentation Requirements - list all expected documentation including language and paper formats/size, electronic expectations, versions etc.;
• Codes, Standards and Regulations - summarise here all applicable codes and regulations for the process/machinery;
• Packaging, Transportation and Delivery - summarise all requirements for assurance of effective transportation of the equipment being procured.