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New CDMO Client, Quality Chemical Laboratories, Benefits From InstantGMP’s All-in-One Quality & Manufacturing System...
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
ZetrOZ Partners With Michigan Self-Insurers Association to Educate on Sustained Acoustic Medicine for Workplace...
TRUMBULL, Conn. - October 31, 2022 - (Newswire.com)
ZetrOZ Systems presented to the Michigan Self-Insurers Association 2022 Fall Conference on Oct. 27 about how the ZetrOZ sam® wearable ultrasound device helps patients return to work more quickly after soft-tissue injuries and prevents more severe injuries from occurring.
ZetrOZ Systems has partnered with the organization of self-insured employers on ways to educate businesses on how to prevent and respond to workplace accidents and injuries. The sam® device has been shown in more than 30 clinical studies to deliver significant improvement in joint function, increased pain reduction, and improved vasodilation - all of which ultimately contribute to accelerated healing and increasing integrity of recovered soft tissue. The sam® product line is also shown to mitigate pain from soft-tissue injuries in the upper neck and back, shoulder conditions, and knee osteoarthritis.
"sam® is already helping thousands of lives daily, and we're honored to be partnering alongside MSIA and the self-insured businesses in Michigan to provide effective treatment for workplace injuries," said Dr. George Lewis, CEO of ZetrOZ Systems. "It's incredibly important to us to help treat workers' injuries, relieve pain, improve long-term outcomes, and ultimately, get people back to work sooner."
Statistics show a need for better care for the workforce, particularly at self-insured workplaces. American workers experienced 2.1 million injuries in 2020, according to the U.S. Bureau of Labor Statistics, and 82% of workers at large firms were covered by self-funded insurance plans in 2021.
There also is a need for effective pain relief without potentially addictive and dangerous medications. The United States spends about $1 trillion on opioid use disorder and fatal opioid overdoses (2018, Centers for Disease Control and Council of Economic Advisors). Innovations like the sam®x1 pain relief ultrasound device provide wireless, long-duration ultrasound therapy for injury healing and pain relief without medication.
The Michigan Self-Insurers' Association [MSIA] is a non-profit organization founded in 1952 that has worked tirelessly over the last 70 years to educate self-insured employers on workers' compensation issues. With the goal of reducing and ultimately preventing workplace accidents and injuries, MSIA and sam® are uniquely aligned to empower workers with the tools and resources to protect themselves and their livelihoods.
MSIA's Board of Managers includes DTE, Meijer, Marathon Oil, and representation from many other self-insured employers, and the organization has been a proud partner of Kids' Chance of Michigan since 2013.
"Our sam® product portfolio offers patients a way to mitigate and reduce workplace injury and pain without resorting to opioids or nonsteroidal anti-inflammatory drugs, which have shown to potentially harm more than they help. Now, these hard-working men and women have a chance to safely and properly heal in the comfort of their own homes," Lewis said.
To learn more, visit zetrozsystems.com.
About ZetrOZ Systems
ZetrOZ Systems is leading healing innovations in sports medicine and developing wearable bioelectronic devices for the delivery of sustained acoustic medicine (sam®). Researched and funded by the federal government, ZetrOZ is built on proprietary medical technology of +46 patents and is the exclusive manufacturer and developer of sam®, a product line designed for the treatment of acute and chronic musculoskeletal conditions. To learn more, visit zetrozsystems.com.
Contact Information:
Buse Kayar
[email protected]
Press Release Service by Newswire.com
Original Source: ZetrOZ Partners With Michigan Self-Insurers Association to Educate on Sustained Acoustic Medicine for Workplace Injury Healing
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