About the client
Mentholatum is a US based consumer health and OTC pharmaceutical manufacturer headquartered in Orchard Park, New York and a subsidiary of Rohto Pharmaceutical.
The company operates across two sites; a production facility in Orchard Park and a research and development center in Horsham, Pennsylvania and manufactures products subject to FDA regulation under cGMP and 21 CFR Part 11 requirements.
The challenge
As Mentholatum grew across two sites, the limitations of managing quality documentation through local servers and network drives became increasingly apparent. Documents were stored inconsistently, some on shared drives, some saved locally, with no unified system of record and no reliable audit trail.
The risks were practical as well as regulatory. Concerns around data security, including exposure to ransomware, made continued reliance on local infrastructure untenable.
For a business operating under FDA oversight, where unannounced inspections can occur and 483 observations become public record, the ability to demonstrate that documentation is controlled, current and accessible is a business-critical requirement.
“We were concerned about local file sharing in case something happened where we’d lose access to our local computers. That was one of the major driving factors in adopting a QMS system.” Ross Castellani
Beyond security, the operational case was equally compelling. With a regulatory affairs presence in California as well as the two main sites, the team needed a system where documents could be accessed, reviewed and signed off remotely, without the friction of physical paperwork or uncontrolled file sharing.
“If we’re looking at a document, we can have a Teams meeting, pull it up on Singlepoint, sign off on it right there. There’s a record of them signing off on it. It’s a lot easier for record keeping.” Ross Castellani, Document Specialist
Our solution
Mentholatum selected Singlepoint following a recommendation from its UK affiliate, which was already using the platform.
The decision reflected both the strength of that internal endorsement and a clear assessment of total cost of ownership. Singlepoint delivered the document control and compliance capability the business needed at a cost that enterprise-tier platforms could not match.
The platform has since been deployed across both US sites, with document control as the primary use case. The production facility in Orchard Park manages SOPs and manufacturing documentation for shop floor and back office teams, including shift workers who access the system via shared terminals.
The R&D site in Horsham uses Singlepoint for research documentation and collaboration, maintaining records of studies and development work in a single, searchable location.
For a manufacturing environment with multiple shifts, shared terminals and varying levels of digital literacy across the workforce, the accessibility of the platform has been a consistent operational priority.
The Results
Cloud migration delivering measurable cost savings
At the start of 2026, Mentholatum migrated its Singlepoint instance from a hosted hardware server to a virtual machine environment. The transition eliminated the cost of dedicated server hosting, delivering savings of approximately $18,000 annually.
The migration itself was handled with minimal disruption. The Singlepoint platform transferred cleanly, with only minor configuration adjustments required to replicate notification settings and system preferences.
“The migration was straightforward. It’s running better than before. Fewer errors, fewer interruptions. Now it’s just 24/7.” Ross Castellani, Document Specialist
Always-on availability for a multi-shift, multi-site operation
Moving to cloud infrastructure removed the dependency on physical hardware and the downtime risk that came with it. For a production environment running three shifts, 24/7 system availability means that operators on every shift can access SOPs and controlled documents when they need them, not just during business hours.
Singlepoint’s document lifecycle management including, automatic conversion to controlled PDF, watermarking, version control and approval workflows ensures that every operator accessing a terminal can retrieve a current, controlled document without requiring system expertise.
“If an auditor walks in and asks an operator to pull up their SOP and they can’t do it, that’s a problem. We have three shifts. Everyone has to be able to access the system.” Ross Castellani, Document Specialist
FDA audit readiness as standard practice
Mentholatum operates in an environment where FDA inspections are unannounced and 483 observations are publicly disclosed. The team monitors 483 findings at peer companies as a proactive signal of where compliance gaps are likely to be scrutinized and uses that intelligence to ensure their own documentation posture is current.
Singlepoint’s controlled document lifecycle, electronic signature capability and approval audit trails support this posture directly, providing the evidence layer needed to demonstrate that processes are followed, not just documented.
Direct access to support at a business-critical scale
Mentholatum has maintained a close working relationship with the Singlepoint team since implementation, including direct access to senior contacts when issues arise. That accessibility, a practical benefit of working with a focused, responsive vendor rather than an enterprise platform, has meant that high-priority issues are addressed quickly.
“It’s more practical. It’s better for growing businesses, you get the access, the flexibility, the support. It’s not just a huge corporate system where you’re one of thousands of customers.” Ross Castellani, Document Specialist
Looking ahead
With document control and cloud infrastructure now well established, Mentholatum continues to develop its use of the platform, including validation documentation storage and the collaboration module in active use at the Horsham R&D site.
