OCuSOFT Inc. is an American privately held company founded in 1986 and headquartered in Rosenberg, Texas, specializing in the research, development, and supply of ophthalmic and skin care products. The company is best known for its #1 doctor-recommended eyelid cleanser, OCuSOFT Lid Scrub, and operates nationwide, serving eye care professionals with innovative solutions and superior customer service.
Summary
Ocusoft, a leading US-based pharmaceutical company, partnered with us to digitalize their quality management processes using our EQMS (Electronic Quality Management System). The project aimed to achieve regulatory compliance, improve operational efficiency, and enhance visibility across key quality activities.
Challenges
Ocusoft faced the need to replace fragmented, manual quality processes with a centralized, compliant, and scalable system. Key challenges included:
- Manual workflows causing delays in approvals and issue resolution.
- Limited real-time visibility into quality metrics for leadership teams.
- Difficulty maintaining consistent compliance with FDA guidelines
- Inefficient audit preparation due to scattered documentation
Ocusoft EQMS Modules Implemented
| Module | Purpose | Impact at Ocusoft |
|---|---|---|
| Change Control | Streamline and track changes to processes, products, or systems. | Faster approvals, reduced errors |
| Corrective & Preventive Action (CAPA) | Corrective & Preventive Action (CAPA) Manage root cause analysis, corrective actions, and prevent recurrences. | Improved issue resolution, stronger compliance |
| Deviation Management | Log, assess, and resolve process deviations. | Reduced operational risk, well-organized audit records |
| Market Complaint Management | Capture, investigate, and resolve customer complaints. | Enhanced customer satisfaction, quicker resolution times |
| Audit Management | Plan, execute, and track internal and external audits. | Faster audit closure, improved compliance readiness |
| Vendor Qualification | Qualify and monitor suppliers and service providers. | More reliable vendor base, minimized supplier-related risks |
Key Benefits Realized by Ocusoft (Outcome)
- Single Source of Truth: Centralized platform for all quality data, eliminating silos.
- Real-Time Visibility: Dashboards and reports for leadership monitoring and decision-making.
- Compliance Automation: Automated workflows reduce manual errors and ensure adherence to FDA regulations.
- Process Efficiency: Electronic forms, task assignments, and notifications speed up closure rates.
- Audit Readiness: Audit trails and document management have made Ocusoft always prepared for regulatory inspections.
- Collaboration: Cross-functional teams worked together seamlessly within the system.
Day-to-Day Impact
- Expertise in pharma industry compliance and digital transformation.
- Proven track record with US customers, including Ocusoft.
- Modular approach, scalable to your company’s growth requirements.
- Dedicated support and training for smooth onboarding.
Industry
Pharmaceutical Manufacturing
Location,
Rosenberg
Employees,
150+
Time for deliveryÂ
90 days
What do you want us to do in this ?
We will assure our best services. In this time and in case of any need we will be there for you.Â
