Software Solutions

ERP is a software system that helps businesses streamline their core processes. ERP systems can integrate processes like finance, human resources, supply chain, sales, and procurement into a single platform. 

ECM is a software system(s) for managing, storing, and analyzing business content. It involves capturing, storing, preserving, and delivering content to support organizational processes.

FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures

Electronic Records: any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

Electronic Signatures: a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Open System: an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

Closed System: an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

LINKS

SOFTWARE PRODUCTS

Sparta Systems (acquired by Honeywell 2021) offers modular software solutions in TrackWise Quality Suite and TrackWise Manufacturing Suite.

Microsoft’s SharePoint is used to securely collaborate, sync and share content.

SAP was founded in 1972 and offers modular enterprise resource planning (ERP) software.

OpenText acquired Documentum, an enterprise content management (ECM) software solution, in 2017 and is now part of Open Text Content Cloud.

Veeva Systems is cloud-based software for the global life sciences industries.