A pragmatic, cost effective and timely, risk based approach to computer systems validation in the life science industries
IT System Risk Assessment
In recent years Regulatory Authorities, including the FDA, EMA and MHRA have moved towards a risked based approach for assessing the quality and safety of IT systems. Amjoco’s wide experience and background allows us to offer you a pragmatic approach to assessing the risks within your IT systems and infrastructure. We will work with you, your subject matter experts and your Quality professionals to establish key risks and then design and implement validation to match.
Computer System Validation Planning
For both new and legacy systems best practice is to establish an appropriate validation plan based upon risk assessment and discussion with all system stakeholders and subject matter experts. Gone are the days of the one size fits all Validation strategy. Regulatory Authorities expect you to target your Validation. We can help you develop a light touch where the risk is small and a more extensive one where it is greatest.
Formulation and Delivery of Computer Systems Validation Methodology
Once a validation plan is agreed Amjoco will formulate and develop either a specific CSV methodology or corporate CSV methodology if required. The validation of any system is only as strong as its foundation and this starts with your organisation’s policies and procedures. However, here too we embrace a risk based approach. If you are a large organisation then you will likely need more distinct policies and procedures than if you are a small CRO or Biotech.
Liaison with QA Function or external QA consultants to develop and implement validation plans
If you are a large organisation with many consultants, a small organisation with no in-house specialists or, if you are lucky enough, have you own in-house function, we will work with your Quality specialists to understand where they are setting the bar. We understand that if you are only dealing with Regulatory Authorities the bar is set at one level, but if you are being audited twice a week by customers all round the world, it is set somewhere completely different.
Development and execution of formal testing
Regardless of whether you are working within a GxP regulated environment or not, it makes sense to test. You’d want to know you were going to get paid at the end of the month after having a new Accounts system installed. The question is when is enough, enough and our experience will help you answer that. We know that you have a business to run and testing costs time, money and resource, but so do bugs.
In a small organisation everyone wears many hats and we’ve been there, so we’ll work with you, so you can live with the processes and procedures we leave you with. We will leave you with processes and procedures you can resource within your budgets and that your staff can follow within their daily duties.
Development and execution of Change Control Processes
In our experience the most difficult time to maintain the level of Quality you want is when the system is Live and you are implementing changes, such as bug fixes or system enhancements. There is an inherent pressure to get it done NOW, but our experience would also suggest that not doing it right causes more problems than you are trying to fix. We will work with you to design a Change Control process that works with the resources you have available and the pressure you are under.
Validation, Retrospective Validation, Re-Validation of GxP Computer Systems
Whether you are new organisation or a large one that has maybe bought a new site, there are times when you realise that systems, processes or procedures aren’t up to the standard you have set for your organisation. Relax, you aren’t the only one this has happened to.
You should also relax because we know how to fix it. We need some time to make an assessment of the systems you have in place and where each of them are in terms of you defined standards and Regulatory requirements. After that it is simply a case of prioritising and getting on with it
Training and Mentoring of IT and QA staff in computer systems validation
The most critical part of any system is the people that function within it. We know that unless they are properly trained in the system, the processes and procedures that sit around the system and see real value in those processes and procedures, compliance can be inconsistent. We have extensive experience training and mentoring staff in all the activities associated with the validation of computer systems. Whether that be bespoke development, system integration, change control , configuration control, system handover, installation or one of the many processes that sit in-between.
System Release and Installation
System Release and Installation is a common weak spot as it is where the development team handover to the operations team. Utilise our experience and expertise to make this step as strong as the rest of your procedures and ensure an efficient, effective and compliant release and installation
We’ll help with training materials, training of staff, performance monitoring, support those changes that inherently happen shortly after a roll out or whatever you need.
If it isn’t written down then it never happened. We all know this adage, but Amjoco live by it and because of that we are good at it. That also means we know when enough is enough. We will deliver effective and efficient documentation you can use and we’ll do it quickly.