Many [...] Read More
Regulatory compliance can be tricky, especially when it comes to your overarching quality management services. There are many guidelines, regulations and laws to understand in order to be compliant in [...] Read More
As you make efforts to adhere to guidelines and regulations created by diverse international bodies, you may find your firm pursuing numerous paths to compliance simultaneously. While there’s nothing wrong with taking specific approaches to each relevant quality [...] Read More
Pharmaceutical firms that wish to create product lines and cater to consumers as reliably as possible must ensure that their products are of a consistently high enough quality to fulfill user needs. While certain post-production checks and assurances can aid in this area, many organizations find it far more helpful [...] Read More
Modern quality management systems are often called upon to help their users meet varied regulatory standards and guidelines. For instance, your company may employ a single gap-analysis scheme to prepare your production lines for FDA and ISO audits and alike and simply plug in [...] Read More
The FDA requires medical device manufacturers, pharmaceuticals manufacturers, biotech companies, biologic developers, and other FDA-regulated industries to comply with their regulations and implement controls.
These controls should also [...] Read More