Pinpoint QMS Services
A company in life science is ultimately faced with a new Management System or help with an existing one. Where do they turn for answers? We have a network of experienced Consultants and Auditors with the skills to advise and consult with you. The mantra in this business is to say what we do and do what we say and that’s how we operate. We start with the interface concept using a network of experts to support your objectives. We also feel its important to understand that such efforts deserve the thrust of quality project management. That’s where we start.
We offer scoped project services and an ongoing consultancy with system implementation providing ongoing support for a range of Standards and FDA regulation. These may include ISO13485 for MedDevice, FSCC22000 for food safety or 21 CFR 110/111/117/211/820 for cGMP compliance. As “Agile” oriented thinkers we are not constrained to the box when it comes to using sound practices to get the job done. We sustain the pareto rule of knowledge which is the 80 percent you don’t know, you don’t know to the 20 percent you can already do well and apply in practice. There is a lot out there to bring to your fingertips and knowing how and what to apply is our specialty!
In addition, we are sensitive to the key esoteric components of such systems including data security and validation in your business – no matter the size or requirements – through our network of services and interfacing responsibilities we can get it done right the first time with the most current approach.
Our aim is to ensure your business continues to benefit from what we have learned, qualified and convey to you our customer.