Sometimes in life you simply do not have the expertise or time to manage a specific project. These situations are just some examples of when it is great to have a consultant join your team.
A good audit helps you build confidence in your Quality Management System and can shine a light on compliance issues before they become a problem impacting certification or licencing.
When you need to ensure the repetition of a process or activity, and when it is a critical step in the manufacturing of a therapeutic product, validation is often the only answer.
Offering quality and regulatory consulting services to organisations of all sizes within manufacturing and distribution, Critical Compliance can assist you in achieving your compliance goals. We focus on helping you reach and maintain the highest standards of product quality and safety, so that you can focus on other things.
Sometimes in life you simply do not have the expertise to manage a specific project, and at other times it may be that you simply do not have the time. These situations are just some examples of when it is great to have a consultant join your team, and either bolster your existing capacity or bring the specialist knowledge required to get the job done. At Critical Compliance, we are eager to join your team!
Auditing is a critical component to any Quality Management System, and a key element in continual improvement. A good audit helps you build confidence in your Quality Management System and can shine a light on compliance issues before they become a problem impacting certification or licencing.
Whether your Quality Management System is certified to ISO 9001, ISO 13485 or PIC/S GMP, there is a requirement to implement a process for Internal Auditing. Finding an auditor who is both competent and independent of the system being audited is vital.
Ensuring control over high risk suppliers or vendors is critical to maintaining product safety, and something we often allow ourselves to forget. Becoming complacent, and having blind faith in critical suppliers or vendors, can be the precursor to your next adverse event or recall action.
There are many reasons for conducting an audit, such as preparing for certification or even ensuring compliance with the latest standards. If you think you might need an audit, then Critical Compliance can help.
When you need to ensure the repeatability of a process or activity, and when it is a critical step in the manufacturing of a therapeutic product, validation is often the only answer. Validations often require many staff hours and the expenditure of large sums of cash, both of which are wasted if the end result does not satisfy the auditor. Why leave it up to chance, when Critical Compliance can help!
Once the most common mode of terminal sterilisation for healthcare products, the use of gamma radiation is still common practice and relatively easy to adopt for the right products. However, it is not without its challenges.
Many manufacturers will advertise their Medical Devices as reusable, but the responsibility of ensuring the product can be safely reused is with the manufacturer. If an auditor asked you to show how cleaning, sterilisation, reuse, and the life of the product was verified, could you answer with confidence?
When you are manufacturing Medical Devices or Medicinal Products, the validation of critical processes is an ongoing struggle. Not every organisation has a full time validations specialist, but sometimes you need one!
Although the most common mode of terminal sterilisation for healthcare products to date, Ethylene Oxide sterilisation can be quite a challenge to setup due to the complexity of the sterilisation process. Getting the validation right the first time is crucial, if you want to meet deadlines and prevent a cost blowout.
Perhaps you are just getting started, and need a bit of knowledge or a helping hand? Maybe you just don’t know where to begin. Let Critical Compliance and our network of professional contacts provide the answers, we love a challenge!
It’s quite rare to come across someone as talented Ben. He was able to provide us with excellent technical advice about a new device application and setting up a controlled environment. He has a depth of knowledge of International Standards relating to controlled environments and is able to explain very technical aspects in a way that the not so technical minded can comprehend. Ben has been a pleasure to work with, always professional and can think outside the square to provide solutions.