Health

New CDMO client, Quality Chemical Laboratories, benefits from InstantGMP’s all-in-one quality & manufacturing system and software auditing for GMP manufacturers

Leave a comment



CARY, N.C. (PRWEB)

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 their 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. Their clients range from small start-up companies to some of the most prominent pharmaceutical corporations in the world.

As their 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.

Their exhaustive search for a new software system led them 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, they 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 new professional relationship, 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 their needs for improved processes and assured compliance. We wish them continued success in the contract formulation development and manufacturing industry and thank them for helping us enhance our software during the auditing process.

To learn more about InstantGMP PRO, its new features for CDMOs, or our software auditing processes for GMP manufacturers, contact us to schedule a demonstration.

About InstantGMP™, Inc.

Founded by pharmaceutical industry veteran Dr. Richard Soltero, InstantGMP, Inc., offers affordable all-in-one manufacturing and quality software. The company develops cloud-based electronic batch record software and standard operating procedures specific to industries that are required to follow FDA manufacturing regulations and Good Manufacturing Practices (“GMP”).

As a manufacturing software company, InstantGMP™ pioneered accessible, easy-to-use electronic batch record software for products manufactured using GMPs. The Company’s updated software simplifies the documentation and approval procedures for quality processes that keep all quality documentation organized in electronic format while providing for quality checks and workflow processes to make compliance with FDA requirements easy.

Share article on social media or email:

Leave a Reply