Friday, September 22, 2023

New CDMO Client, Quality Chemical Laboratories, Benefits From InstantGMP’s All-in-One Quality & Manufacturing System and Software Auditing for GMP Manufacturers

CARY, N.C. - November 1, 2022 - (Newswire.com)

InstantGMP, the originators of the all-in-one manufacturing and quality system, is proud to welcome a new contract development and manufacturing organization, Quality Chemical Laboratories (QCL), to its growing client base.

Quality Chemical Laboratories was founded in 1998 as a raw material testing laboratory and has continuously expanded capabilities and service offerings. For over 25 years, this leading CDMO has provided GMP-compliant formulation development and manufacturing services for the pharmaceutical industry. The company's clients range from small start-up companies to some of the most prominent pharmaceutical corporations in the world.

As its client base continues to grow, Quality Chemical Laboratories recognized the importance of implementing a new software system to enhance its processes while gaining efficiency and maintaining GMP and FDA compliance.

QCL's exhaustive search for a new software system led the company to the InstantGMP PRO system. While the software's all-in-one capabilities impressed the QCL team, they required computer system validation to determine if the system:

  • Meets FDA Part 11 compliance.
  • Achieves its intended purpose by meeting user requirements.
  • Is free from any installation or performance issues that could negatively impact the integrity of the CDMO's production cycles, raw materials or finished pharmaceutical products.

To ensure that the InstantGMP PRO system was validated, Quality Chemical Laboratories conducted an extensive software vendor audit. During the software vendor auditing process, QCL reviewed every piece of the software's validation documentation and standard operating procedures (SOPs) via a virtual session with InstantGMP to confirm that InstantGMP PRO:

  • Is properly validated.
  • Vendor documentation can be appropriately leveraged to save QCL significant time and resources.
  • Functions accordingly and accurately.
  • Aligns with the information defined in the provided user requirement documentation.

After QCL reviewed all the respective documentation and asked any pertinent questions, it created and supplied a detailed audit report that identified topics that required further discussion and some minor issues that needed to be resolved. At the conclusion of the audit process, InstantGMP successfully satisfied Quality Chemical Laboratories' requirements.

Not only did this process lead to a successful relationship, but it also provided the QCL team a better understanding of the software's full capabilities. Additionally, the audit process offered InstantGMP an opportunity to address previously unidentified issues and further enhance the software with new features that best meet manufacturers' needs.

InstantGMP is excited to provide Quality Chemical Laboratories with a validated all-in-one software system that truly meets its needs for improved processes and assured compliance. InstantGMP wishes them continued success in the contract formulation development and manufacturing industry and thanks them for helping InstantGMP enhance their software during the audit process.

To learn more about InstantGMP PRO's new features and software auditing processes for GMP manufacturers, contact us to schedule a demonstration.


Contact Information:
Robert Pochadt
Director of Sales
[email protected]
215-975-9660

Jeremy Hall
Technical Sales Manager
[email protected]
757-759-4500


Related Files
InstantGMP PRO for FDA Requlated Industries 4.22.pdf



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Original Source: New CDMO Client, Quality Chemical Laboratories, Benefits From InstantGMP's All-in-One Quality & Manufacturing System and Software Auditing for GMP Manufacturers
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Introducing EFS’s Fusion Energy AI Ambassador

Electric Fusion Systems Launches AI Chatbot to Demystify Fusion Energy Queries

Introducing EFS’s Fusion Energy AI Ambassador
Electric Fusion AI Ambassador

Icon for EFS artificial intelligence chatbot that is trained on scientific papers related to EFS fusion technology.

Electric Fusion Systems (EFS) acknowledges the challenges faced in conveying the intricacies of our novel fusion approach to a skeptical fusion industry and intertwined subject matter experts. Recognizing the need for improved clarity, EFS has launched an AI Ambassador on its website designed to facilitate informed discussions about its technology.

Powered by ChatGPT-4 from OpenAI, this AI Ambassador is grounded in peer-reviewed scientific research, particularly focusing on the intricacies of EFS’s Light Element Electric Fusion (LEEF) technology. "Our database currently encompasses around 70 research papers, and we continuously enhance it, prioritizing the relevance and scientific rigor pertinent to our fusion technology," said Ken E. Kopp, CTO.

Central to EFS's innovation is our unique Rydberg matter bulk fusion fuel condensate made from lithium ammonia and noble gases through a special proprietary process. This innovation notably reduces the traditional fusion thresholds (in temperature, time, and density) for proton-lithium aneutronic (radiation free) fusion reactions, introducing the potential for small-scale portable and low-cost fusion energy.

“When we discuss our technology with fusion subject matter experts at the Department of Energy (DOE) or Advanced Research Projects Agency-Energy (ARPA-e), they ask questions like, what is Rydberg matter? Or, what are coulomb explosions? This is both encouraging and very sad. In the sense that no one seems to be aware of this potential Rydberg matter-based proton-lithium fusion pathway and, at the same time, frustrating at scientific skepticism and incredulity that dismisses our hopes of funding,” said Ryan S. Wood, CEO. This situation is a driving force in developing the AI Ambassador, aiming to facilitate comprehension of EFS's technology from a scientific lens.

Existing fusion energy designs require a massive investment with an estimated $4,500 per kilowatt-hour installed cost and operating costs of $50 per megawatt-hour or higher. These fusion plants are on par with current light water fission nuclear power plants in terms of size and are still years or decades away from practical implementation.

EFS's patent-pending fusion technology and direct-to-electricity apparatus have the potential to drastically reduce these costs by a factor of 5-20 times. We are targeting $5 per megawatt-hour, potentially cannibalizing renewable energy, hydrocarbons and creating civilizational change.

EFS's venture into clean fusion energy holds promising implications for the energy domain. The success of our technology will ultimately depend on validation by experts and third-party replications confirming more power out than in. 

Contact Information:
Ryan Wood
CEO
[email protected]
303-941-9663


Original Source: Introducing EFS's Fusion Energy AI Ambassador
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