CMO client benefits from InstantGMP’s all-in-one system and software auditing for GMP manufacturers.
CARY, N.C. September 20, 2022 – InstantGMP, the originators of the all-in–one manufacturing and quality system, is proud to welcome a new contract manufacturing organization (CMO) to our growing client base.
For over 20 years, this leading CMO 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, this North Carolina-based CMO recognized the importance of implementing a new software system to enhance its processes while maintaining GMP and FDA compliance.
Their exhaustive search for a new software system led them to InstantGMP PRO.
While the software’s all-in-one capabilities impressed the CMO team, they required validation to determine if the system:
- Meets FDA compliance
- Achieves its intended purpose
- Is free from any installation or performance issues that could negatively impact the integrity of the CMO’s production cycles, raw materials or finished pharmaceutical products.
To ensure that the InstantGMPTM PRO is validated, the CMO conducted an extensive software audit.
During the software auditing process, the CMO reviewed every piece of the software’s validation documentation and standard operating procedures (SOP) via a virtual session with InstantGMP to confirm that InstantGMPTM PRO:
- Is properly validated.
- Functions accordingly and accurately.
- Aligns with the information defined in the provided documentation.
After the CMO 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 they needed to be resolved.
At the conclusion of the audit process, InstantGMP successfully satisfied the CMO’s requirements.
Not only did this process lead to a successful new professional relationship, it also provided the CMO team with 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 this new CMO client 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 manufacturing industry and thank them for helping us enhance our software during the auditing process!
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.