PROCESS CATALOG

A Document Management System (DMS) is an electronic solution for drafting, reviewing, approving, tracking and storage of organizational documents...

 

An innovative Learning Management System (LMS) is designed to offer everything from training to record management, to simplify the distribution of courses to employees/students, all done over one network... 

Change control is a formal process ensuring changes to a product or system are introduced in a controlled, synchronized and well-coordinated manner. Reducing the possibility of unnecessary changes...

Deviation and nonconformity processes are core processes in a quality system. Regulations require organizations to investigate, plan and implement actions in order to find the root cause of an event that’s deviant...

Corrective and Preventive Actions (CAPA) improve an organization's implemented processes, eliminating causes of nonconformities or other undesirable outcomes or scenarios...

Supplier Quality Management is comprised of a set of procedures and processes in the organization's quality systems. Designed to increase the confidence in a supplier's ability to deliver quality goods or services...

As the reliance on Contracted Manufacturing Organizations (CMOs), critical suppliers and distribution partners grows, so too does the need to connect quality processes of the entire supply chain...

Adverse event reporting and complaint handling processes are designed to ensure that report of potential failure to meet required product quality, safety standards or customer expectations are systematically captured...

Regulatory affairs processes in our system are designed to ensure compliance of organizations with regulations and laws, while also supporting communication with regulatory agencies and personnel. Registration of products, product variation, and registration...

Electronic Batch Record (EBR), also known as Batch Production Record (BPR), or Batch Manufacturing Record (BMR), is the methodology applied to manage and document manufacturing processes in highly regulated industries...

Device History Record, also is known as DHR, is the methodology employed to ensure high quality manufacturing processes in the medical device industry. The DHR process demonstrates how each specific device was manufactured...

The role of Dot Compliance’s Risk/Impact Assessment & Management module is to provide a detailed and systematic appraisal of the potential impacts of an amendment, alteration, or event...

The Dot Compliance Suite Audit Management module helps simplify and organize work and collaboration processes of compiling audits. By ensuring that internal/external audit directives...