Cary, NC – InstantGMP™ has completed validation of the latest version (v3.0) of its cloud-based electronic batch record software. This system was designed for manufacturing products according to regulations set by the Food and Drug Administration (FDA) and European Union (EU). The software is validated to meet those regulations and also complies with:
- 21 CFR Part 11: Electronic Documentation and Electronic Signatures
- Current Good Manufacturing Practices (cGMP)
- General Principles of Software Validation: Final Guidance for Industry and Staff
- EudraLex: The Rules Governing Medicinal Products in the European Union Volume 4 Annex 11: Computerised Systems
- General Automated Manufacturing Practices (GAMP 5)
- ISO 9001
- ISO 13485
This latest validated version includes many new features that will benefit biotech and pharmaceutical by monitoring the production process in order to prevent errors, mistakes, and decreasing batch rejections. They software also works by automating the creation of Master Batch Records and the generation of Batch Production Records.
InstantGMP™ software solutions focus on being an “all-in-one” tool by implementing GMP centered workflows that provide infrastructure, simplification of production and promotion of “Right the first time” manufacturing. In addition, it boosts resource efficiency by eliminating the post-batch chaos and the redundancies in quality assurance.
InstantGMP™ PRO v3.0 is an attractive GMP Manufacturing software system for companies that need cost-effective alternatives to on-site IT and computer validation. Additionally, electronic batch records are able to surpass the limitations and inefficiencies of paper-based systems.
Stay tuned for the latest updates from InstantGMP and learn more about how InstantGMP PRO can benefit pharmaceutical and biotech manufacturers.
InstantGMP™ Inc. was developed by pharma industry veteran Dr. Richard Soltero to help companies to better manage their production process and comply with Good Manufacturing Practices (GMPs). InstantGMP™ takes a personalized approach to company needs by offering a wide variety of customizable software solutions, Standard Operating Procedures (SOPs), and process consulting.
For media inquiries, please contact Marketing Manager, Kelly Waters at 919-657-0956 or KWaters@InstantGMP.com.