InstantGMP, the originator of the all-in-one manufacturing and quality system, has welcomed 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 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 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.