Batch Records are testimony to the fact that your life sciences company is recording all crucial details of every batch of product you manufacture. The recorded information will assure your company’s internal and external stakeholders, including regulatory agencies,...
The complete documentation about the manufacturing and tracking of every medical device that your company sells is contained in a Device History Record (DHR). As per current international regulatory guidelines, your medical device company must maintain DHRs (or...
Medical device document management and control is the underpinning of your company’s Quality Management System. The documents and records that you maintain and how you control them will highlight to the world that your products are safe and efficacious to use. Under...
Considering the amount of documentation that is required for pharmaceutical companies, efficient document management is essential. Pharmaceutical document management can be defined as a repository of all the documents that your organization (be it pharmaceutical,...
When a life-sciences organization has an effective quality management system (QMS) in place, it is demonstrating to its end-users and the regulatory agencies that its products/services are of the highest industry standards. Similarly, when the sponsor of a clinical...
