About the client
The Mentholatum Company (TMC) is a US based company who develops, manufactures and sells over the counter (OTC) topical consumer products as well as cosmetic products.
As a company registered with the U.S. Federal Drug Association, TMC is mandated to adhere strictly to cGMP guidelines and regulations.
The challenge
Before adopting Singlepoint’s Document Management System two years ago, TMC predominantly operated in a paper-based environment.
The company was in dire need of a software system that would not only manage their cGMP documents effectively but also comply with the stringent 21 CFR part 11 compliance requirements.
This need was intensified by the inefficiencies and compliance risks associated with their existing paper-based system.
Our solution
Singlepoint’s DMS was chosen for its robust capabilities and security measures that controls access and permissions for users.
Singlepoint offers a secure, web-based platform that mandates SSL certification for access. It also requires individual user credentials, including strong, periodically changeable passwords.
“Each document within the system can also be set with specific user access with varying permission levels.”
Steve Stover, Manager, Analytical Development, The Mentholatum Company
This system is also designed to offer comprehensive security features, such as locking out users after several failed login attempts and establishing general permission levels for each user.
Furthermore, Singlepoint allows for intricate control over document accessibility, where each document can have unique user access permissions. The system’s ability to enforce document control ensures that TMC’s critical information is always up-to-date and secure.
The system supports intricate approval workflows, enabling multiple individuals and/or groups to review documents, with automatic notifications dispatched upon document publication. A key feature is that it only displays the most current version of a document to general users, ensuring that only the latest procedures and methods are used. This is crucial for maintaining up-to-date and compliant practices.
Singlepoint’s DMS also includes a robust audit trail for each document, capturing every version’s history as well as the overall document lifecycle.
Editing approved documentation is restricted to authorised personnel, and the system ensures that only one person can edit a document at any given time. Importantly, once documents are registered in the DMS, they cannot be deleted (although this function can be modified if necessary).
The Results
Since implementing Singlepoint’s DMS, TMC has seen substantial improvements, particularly in audit readiness and document management efficiency.
The system has been instrumental during various audits, including UL audits and company-specific audits, owing to its effective search functions and streamlined document accessibility.
The introduction of Global Document Property Groups (GDPGs) has significantly reduced the administrative workload, facilitating a smoother document registration process.
TMC’s transition towards a paperless workplace has been significantly accelerated by Singlepoint’s comprehensive features and user-centric design.
“Singlepoint is very responsive to technical issues which may arise while utilising the system and is always open to ideas on improving the system.”
The overall impact of Singlepoint’s DMS on TMC has been transformative, streamlining processes and maintaining a culture of compliance.
“Overall, the Singlepoint software system has allowed us to begin the process of becoming a paperless workplace while also maintaining compliance.
The Mentholatum Company would recommend Singlepoint to any company who is looking to move in the direction of document control especially for those companies required to abide by cGMP and 21 CFR part 11 compliance requirements.”
Steve Stover, Manager, Analytical Development, The Mentholatum Company
