
Software Solutions
In today’s digital-driven world, businesses rely on software solutions to enhance efficiency, streamline operations, and drive innovation. However, selecting, developing, and implementing the right software can be complex and challenging. QBit QA Consulting consulting helps organizations navigate this landscape by providing expert guidance in software strategy, development, integration, validation and optimization.
ENTERPRISE RESOURCE PLANNING (ERP)
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.

ENTERPRISE CONTENT MANAGEMENT (ECM)
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.

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.
- Clinical Platform
- Regulatory Information Management
- Quality
- Content
- Training
- Process
- Lab
ISO
- ISO 13485 Medical Devices – Quality management systems – Requirements for regulatory purposes
- ISO/IEC 27001 Information security, cybersecurity and privacy protection – Information security management systems – Requirements
ISPE
- GAMP Guide: Records and Data Integrity Guide
- GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data
- GAMP Good Practice Guide: Global Information Systems Control and Compliance
- GAMP Good Practice Guide: A Risk-based Approach to GxP Compliant Laboratory Computerized Systems
- GAMP Good Practice Guide: A Risk-based Approach to GxP Process Control Systems
- GAMP Good Practice Guide: IT Infrastructure Control and Compliance
- GAMP Good Practice Guide: A Risk-based Approach to Operation of GxP Computerized Systems
- GAMP Good Practice Guide: A Risk-based Approach to Testing of GxP Systems
- GAMP RDI Good Practice Guide: Data Integrity – Key Concepts
- GAMP RDI Good Practice Guide: Data Integrity – Manufacturing Records
- Baseline Guide: Pharma 4.0