Is this user requirements process mandatory?
No, there is no regulatory requirement to use this process. It was however developed by a large team of industry experts from both the biopharmaceutical manufacturer and supplier community as the best practice to issue and respond to user requirements as part of the specification generation and procurement process. The process and document templates were specifically developed to comply with the ASTM E3051 – Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing.
Is there a guidance document to follow when setting up our new user requirements process?
How do suppliers update, revise answers or add information such as further testing or additional product information to an earlier submitted User Requirements Template?
Suppliers can contact end users to make updates and changes. End users can also resend the template to suppliers to make sure all responses are up to date. The template also has an embedded table for version control.
How do I fill in the User Requirements Template when not applicable to the request? For example, will “N/A” or something similar be acceptable to the end user?
Responding companies can use “N/A” as an appropriate response. Also, be sure to include an explanation or clarification as to why.
What if some of the questions are for information we consider confidential or proprietary?
It is recommended that you have an NDA as part of the transfer of information process In situations where the information is too sensitive to be transferred electronically, the recommendation is to allow the information to be viewed during an in-person audit (under an NDA).
Is there a way to remove questions that don’t apply to our application?
Yes, within the User Requirements Template the requesting company can simply indicate that this information is not required.
Is there a way to add questions that are not part of the User Requirements Template?
Yes, throughout the template there is space dedicated to inserting additional project specific questions not included in the template.
Where can I get additional help to understand and implement this process?
Is this for single-use both systems or for components?
Yes, the User Requirements Template was specially developed for use for procurement of and sale of single use equipment and systems. The User Requirements Template is primarily intended to summarize the user requirements for a single use system such that SUS suppliers can design the system to meet the user requirements. It may also be used to specify requirements for single use components, but this is not the primary intended use.
What is the benefit to supplier companies to adopt this practice?
By using this User Requirements Template to respond to customer requests for quotation, the supplier will be able to efficiently and consistently gather the required information to ensure a design meets customer requirements, enhancing the reliability of single use systems in our industry. Suppliers may opt to establish a library of answers that can be used for future quotes; thus hopefully over time reducing the number of staff hours required to respond to end Users’requests. Standard single use systems may also be supported using the template to summarize the design criteria used during the development phase of a standard product (non-custom).
What is the benefit to end User companies to adopt this practice?
By establishing the User Requirements Template as a common practice for specification generation and procurement of Single-Use equipment and systems, the end users will be able to standardize the information they need for decision making, ensure that all regulatory and company requirements are met, establish consistency across multiple sites and ease the comparison of solutions posed by multiple suppliers. By using these documents in compliance with E3051, end users can demonstrate to regulators appropriate diligence in the implementation of single use systems (SUS).
Is there a revision control to know that supplier and end user are using the latest User Requirements Template?
A. The latest version of the template can be found on the BioPhorum website under the resources tab or the BPSA Website under the technical documents tab. Revision control happens behind the scene. Only the latest version appears on these two websites.
Is there a depository where the User Requirements Template with answers are kept for later review between the supplier and end-user?
A. The repository of answered User Requirements Templates should be discussed between the supplier and end user. An arrangement ahead of time will help the process.
B. End users should maintain a record of the specification, design and verification of the SUS they buy so that they may use existing system for new applications, but only after considering of the existing system meets the requirements of the new application. Save
How do I get all of my suppliers (or customers) to adopt this practice?
Education across the industry is key, but we expect the end users be the real drivers. If they adopt it, recommend their peers adopt it and use the template when sending it out to all suppliers, thus elevating it to a standard practice in the industry. It is also important to have internal champions within the organizations (both end users and suppliers) implementing the change to this standardized format.
When would you possibly not use this User Requirements Template?
When you are purchasing equipment, bags, tubing or components from suppliers that are already qualified with a material that has been validated. Having a historical response will enable you to easily make purchases of similar product with varying sizes.
When should you use the User Requirements Template?
You should consider using the User Requirements Template as the first step in the specification, design and verification of a single use system anytime you are dealing with a supplier and or piece of equipment for the first time. This will allow you to gather a library of information and documentation for future purchases. Also you should consider using the template when releasing a competitive bid to multiple different suppliers. This will enable you to make a more thorough evaluation of the various proposals
What are the methods for answering the questions? Should it be handwritten, typed, etc?
The template is set up to support typed responses, which are typically easier for the user to read.