Tier 2 has significant experience of implementing systems to comply with the FDA’s 21 CFR Part 11, of which Computer System Validation (CSV) is one key part.
Tier 2 demonstrates expertise in FDA compliant custom software
‘Computer System Validation’, in summary is the documented process of ensuring that a system does what it is designed to do, in a consistent and reproducible manner.
In addition to Standard Operating Procedures (SOPs) addressing, for example, the IT infrastructure, there are a number of important Part 11 considerations relating to the design, development and implementation of custom software:
- The systems development lifecycle approach.
- The level and type of documentation produced (including, but not limited to, detailed requirements documentation and test plans).
- Specific features which must be included in the custom software (such as audit trails, electronic signatures, and security features).
As a result, we can add real value to the development of bespoke software solutions; which was very much the case when we created the patient portal used by 14M Genomics.”
Commenting on the successful build and deployment of the RAPHAEL web portal, Fionnuala Patterson, Director of Bioinformatics at 14M Genomics at that time said: “Tier 2 Consulting came highly recommended for this project and the depth of their sector knowledge became apparent from the outset. We were delighted to find that Tier 2’s proprietary document management product (ARENA*) met the bulk of our requirements for RAPHAEL – and that Tier 2’s customization skills could shape the final system specification.
The final specification for RAPHAEL was evolved to accommodate specific audit trail functionality, based on Tier 2’s guidance and expert knowledge of computer system validation and their detailed knowledge of FDA 21 CRF Part 11 regulations.”
Agile Software Development
Tier 2’s standard project delivery approach is based on ‘Scrum’, which is an agile methodology. By ‘agile’, we mean an approach based on iterative and incremental development, where requirements and solutions evolve through collaboration between cross-functional teams.
It promotes adaptive planning, evolutionary development and delivery, a time-boxed iterative approach, and encourages rapid and flexible response to change. Scrum provides a balance between functional flexibility (the ability for users to adapt or add new requirements as they see the solution evolving), and cost control.
Agile in a Regulated Environment
Tier 2 understands and has first-hand experience of developing applications, and the associated documentation, which must comply with regulatory standards, and which has been “validated”.
Thankfully it is not as commonly held a view as several years ago, but some project ‘traditionalists’ have voiced concerns that agile processes are undisciplined, and therefore incompatible with quality management – but the reality is that this is some way from the truth.
The standard disciplines of planning, requirements definition, design and testing are all part of the agile process – a difference being that agile repeats itself in smaller increments. The process is designed to get feedback throughout the course of the development project, and use this feedback to continuously improve the product.
The agile feedback loop can be adapted/extended to accommodate specific regulatory requirements (e.g. risk management, validation, regulatory documentation etc.).
For examples of Tier 2's agile web application development work click here.
Tier 2 works in partnership with our customers to understand their business challenges, and deliver custom software solutions using modern, open-source, cloud-native technology and an agile project approach.