What is PhaseQMS™?
Combine experienced pharmaceutical quality professionals with an electronic, cloud-based quality management system (eQMS) and the result is – PhaseQMS™.
We have packaged our seasoned quality experts with a compliant, commercial, scalable eQMS to provide you with the quality program you need for your early-stage company. Rapidly deployable (within 48 hours) as a complete quality program, PhaseQMS is the only product of its kind in our industry.
We are your quality team – this is not just a software package. Our quality team runs your PhaseQMS system for you. We process your change controls, deviations, vendor audits, documentation review and approval workflows and even your electronic training. All of these actions are recorded in your PhaseQMS system and you interact with the system electronically. It’s kind of like having a contracted IT/QA service for your company.
When you are ready, we can turn the system over to you to manage – you determine when the time is right for you, based on your schedule and your objectives.
PhaseQMS delivers a pre-configured yet customizable QMS with all the quality processes, procedures and databases you need for your project.
Base system modules include:
PhaseQMS is your compliant eQMS staffed and operated by seasoned quality professionals that know how to operate quality systems and processes using phase appropriate GMP principals.
Who is it for?
PhaseQMS is designed for virtual and start-up early phase pharmaceutical companies that need a phase-appropriate quality program but do not yet have the experienced quality staff to operate an in-house quality program. With PhaseQMS, within hours you can have a staffed and fully operational quality function with seasoned quality professionals. PhaseQMS is built upon a commercial, compliant, validated eQMS that we operate for you until you want to take control. When you are ready to take control, we transfer PhaseQMS to you. We can either provide continuing resource support or walk-away as you take the reins. SOPs are of course provided, and training of your staff is included.
Why did we create it?
We created PhaseGxP because we realized there were companies that needed a quality program but were at the stage of development where building a dedicated quality department did not yet make sense. We also realized that the options available to early-stage companies were limited. Options include hiring expensive and difficult to find quality staff or hire expensive consultants – and worse, both of these options frequently produced overly complex, inflexible quality programs that were not appropriate for the phase of development for the company.
After having built and deployed numerous QMS’s with many different companies, we realized that this was an unmet need in the pharmaceutical industry. Most start-ups are strong in science and development but have less experience in quality or compliance. As these companies get closer to their first clinical trial, they realize they need a quality program.
We decided to marry our expertise with an eQMS to provide a flexible solution that would solve this gap in the industry – and thus PhaseGxP was created.
Why an electronic instead of a paper QMS?
Paper systems work, but they are slow and inefficient. It simply takes more time to push paper around, especially in today’s increasing virtual world. However, most early-stage companies cannot afford to implement an eQMS, even if they have the experience and people to do so. We solved that problem by partnering with a leading eQMS vendor with a cloud-based system that is validated, flexible and configurable. We then built workflows that contain our experience with phase appropriate quality practices. We implement and maintain the system for you providing you the quality program you need for your company.
Who are we and why would you trust us to run your quality program?
Quite simply, we are a team of seasoned, quality professionals who enjoy helping companies achieve their vision of developing new drugs to help meet important medical needs. We want to be a part of the challenging process of transitioning a development proof of concept drug to the clinic and do so in a way that supports the product, the patient and the company.
We don’t want to be a bunch of ‘theoretical’ consultants that give you the most conservative and risk-averse advice. Yes, we too have experienced plenty of this type of pharmaceutical consulting in our past pharmaceutical careers. Instead, we offer you our experience combined with a scalable, risk appropriate, transferrable eQMS to help you achieve your goals. Being a small part of your success makes us feel like we contributed in a small way to the movement of that drug from an idea to a reality.
How is PhaseQMS actually ‘Phase Appropriate’?
This is a very important question. Very few companies, people and CMOs have adopted or applied phase appropriate quality to their services or products. Why is that?
In our opinion, there are two logical answers. One, it is expensive and two, not many quality people actually know how to do it! Why do we say that? Deploying phase appropriate quality is expensive because doing so means a company has to have different processes for the same problem based on the phase of the project. It is much easier (cheaper) to use one process for everything, from Phase I – Commercial. Secondly, quality people tend to be conservative and they love consistency and crave rigid, fixed processes. This is great for large companies that can afford to take months or years to make decisions or implement a change, but for early-stage companies, flexibility drives innovation and that is what gets products to the clinic faster.
PhaseQMS is built around our experience implementing phase appropriate quality. The regulatory agencies have acknowledged and given us the opportunity to use phase appropriate quality, yet we as an industry rarely use it! Why? Because it is harder to do, because, as indicated above, it requires thinking out-of-the-box and designing phase-flexible systems and quality processes. The PhaseQMS solution implements Phase Appropriate quality as pre-configured workflows based on a project definition. Depending on the stage or phase of the project, the system will automatically make available the most phase-appropriate process for the quality element being requested (ex. Audit, change control, deviation, etc.)
Quality processes
How does the system work in a real-world scenario?
You decide you need a new viral vector supplier for ‘high quality’ grade material. You think you know who you want to use, but you also want to ‘tick the boxes’ and evaluate a couple of other suppliers, maybe a new one that just became known to you.
You log into PhaseQMS and initiate a new vendor request workflow. To do so, assuming you know the vendor you want to evaluate, you would enter the vendor name and what the vendor is to be used for and submit the request. Our team reviews the request and with your permission we initiate an electronic vendor pre-screening quality questionnaire. The questionnaire is phase appropriate depending on your project. (We don’t want to waste your or their time asking if they have QP certification if the material is only going to be used as a starting material for a FIH clinical study in the US). We work with the vendor to obtain the information and provide you with a detailed vendor request, GxP evaluation appropriate for your project. We enter the results of the evaluation into PhaseQMS and you get an email from the system letting you know that the evaluation is available for your review. You can review our report which is recorded in the system which helps document the process used to evaluate the vendor, thereby fulfilling your quality requirements for vendor evaluation for a Phase I clinical product.