Submit offer Processive Projects – QMS Software Validation 1:1 Sparring

Template for the Task Description
  
A good Task Description must include the following:  
 
1. GENERAL INFORMATION: 
Titel of tender: Processive Projects – QMS Software Validation 1:1 Sparring
Your company’s name:  Processive Projects ApS
Address:  Blegdamsvej 6, 2200 København N, Denmark
CVR nr.:  41898569
Date:  28.04.2026
Deadline for tender:  12.05.2026
For further questions, contact info:  Maria Lund Jensen
Upload of tender info: Use link in task description
Phone and e-mail:  +45 28948323 & maria@processive.dk  
 
2. PRESENTATION OF COMPANY: 
Processive Projects is developing a B2B Saas offering that assists companies in the Medical Device segment and other regulated industries to fulfill the regulatory requirements for documentation of Design Controls during product development. 
 
3. DESCRIPTION OF THE TASK UNDER MARKET EVALUATION: The SW application falls within the scope of Quality Management Software, which means that any company implementing it will need to validate it in accordance with various standards and guidelines.  

Examples are:   

·      ISO 13485 / FDA QMSR (21 CFR Part 820)

·      FDA “General Principles of Software Validation” 2002

·      ISO/TR 80002-2  Medical device software - Part 2: Validation of software for medical device quality systems 

As validation of our product will be a significant consideration for our potential customers, we need to understand in detail what is required and how best we can anticipate and support the effort that will be required by our customer.  We might even be able to strengthen our offering with focused products or services, such as a pre-validation package.   

We already have some knowledge of the SW validation process from our consulting activities.  However, it would be particularly valuable for us to have some focused sparring with an experienced expert on the pitfalls, tips and tricks etc. associated with it.  

 
4. TASK OBJECTIVES AND SUCCESS CRITERIA: 

The task is to deliver one full day session of individual sparring, in person and preferably in Copenhagen, with a view to us being able to define the following for our specific project: 

·      Software validation principles and approach to lifecycle 

·      How to define Intended Use and validation scope

·      Formulation of strategy, protocols and evidence needed

·      Potential impact of CFR 21 Part 11

·      Documentation expectations

Ultimately, we wish to understand how much validation support we can provide as a vendor to reduce friction in the adoption of our product. 

5. BUDGET OG SPECIFICATION OF AN OFFER: 
We expect a written offer to include at least: 
• Date of submission of offer 
• A brief presentation of the bidder, stating the CVR number and contact details. If relevant, with references and history 
• Bidder's proposal for solving the task 
• Specification of the price for solving the task 
• Discount, if relevant 
• Timeframe and end date 
• Conditions for the offer, if any 
 
6. BACKGROUND FOR THE TENDER: 
Beyond Beta is subject to a number of requirements for good, healthy financial management, including documentation that the agreed price for external purchases is an expression of the market price. This tender is part of these requirements. 
We emphasize that the bidder must only make an offer on the requested task.  
Services of executing or implementing nature cannot be approved  
The winning bid is chosen based on an assessment of the best correlation between price and quality