Quality Control In The Pharma Industry

• Detailed and historical audit trails. This is standard functionality in Sage X3 and includes user name, date, time, previous data, new data and the reason for the change.
• Electronic signature framework. This includes tables, programs, actions and objects to store, configure and collect unique e-signatures, which are permanently linked to the object and cannot be modified or copied.
• Document signatures. Documents requiring handwritten signatures, such as Certificates of Analysis or Technical Sheets, are generated with an image linked to the specific document. The image plate is controlled and linked to the user profile.
• Validation workflows. These can be customised depending on the company but can be set up to, for example, not allow release of a drug into stock until the QP has had final, password controlled, sign off.
• Security features. Several security standards safeguard against unauthorized use, including automatic logoff after a period of inactivity, auto logout after too many failed logon attempts and logging of all user activity. Functional access control can also be tailored and/ or limited to specific fields that may contain sensitive information.

Adhering to regulations not only provides companies with the relevant licenses to continue to trade but also sees reductions in system vulnerability, lower compliance-driven costs and shorter validation times. Through a comprehensive solution designed for the Pharmaceutical industry, such as Sage X3, companies can take the pain out of compliance as well as ensuring their overall operational efficiencies. 

Find out more: 

• Watch a free demonstration of Sage X3 for the Pharmaceutical industry here
• See more details on the Mysoft exclusive Sage X3 Pharmaceutical Pack
• Hear from our current customer, Crescent Pharma