Regulated Industry

The pharmaceutical industry face many common challenges in meeting compliance, increase efficiency, accelerate high quality production and adhere to regulatory requirements. Complex production processes, globalisation, and the requirement to operate faster and leaner are just some of the pressures driving pharmaceutical organisations to implement standardised processes in their organisations.

Advantum will deliver minimized downtime, accelerate processes and also eliminate human errors and meet customer expectations in a cost-effective manner.

InfoTech Scandinavia provides Pharmaceutical companies with the most excellent system for quality management, document and drawing management, change control, environmental health and safety, e-batch records, industrial facility management and CAPA solutions including other complex processes in configured workflows.

Some standard functionality is:

• Version control

• Document history and audit trail

• Role based accessibility to content

• Electronic Records and Signatures

• Check In Check Out functionality

• Automated counters

• Configurable to comply with FDA 21 CFR part 11, 820 and
  ISO – EN 13485, cGxP, ISO 9001, 14001

• Possibility to configure automated build of a content submission folder

• Configurable to follow any business process.