OrciMed Builds a Scalable QMS Foundation From Day One

A Scalable Quality Management System for Contract Services Organizations

Founded in 2022 to offer a range of services to cater to Pharmacovigilance, Medical Writing, BioMetrics, Clinical Operations etc to various pharma and biotech companies, paper quality processes simply weren’t an option for OrciMed. They needed an unshakeable quality foundation from day one, and that meant file folders, uncontrolled spreadsheets, and non-compliant signatures just wouldn’t cut it.

It was time to look for a powerful, scalable electronic quality management system (eQMS). With over 18 years of experience managing compliance and training programs, Savita Gupta, Associate Director - Quality Assurance, led the charge.

“We wanted to go paperless right away. Our goal was to have both our QMS and LMS systems set up electronically from the start.” - Savita Gupta, Associate Director - Quality Assurance, OrciMed

With a growing workforce and client base with a project headcount of over 1000 employees by end of 2026, OrciMed needed a more scalable and structured quality system to replace semi-digital workflows. When evaluating quality management software, OrciMed focused on finding a solution that could:

• Handle SOP management and training workflows
• Support quality events such as deviations and change controls
• Deliver a user-friendly experience with strong implementation support

Savita had experience using other quality systems, such as Veeva, but knew OrciMed needed a more user-friendly and well-supported alternative.

“The implementation of ZenQMS was very sound and easy. The support we received from the ZenQMS team – even with the time zone difference – was very good.” - Savita Gupta, Associate Director - Quality Assurance, OrciMed Life Sciences

“The ZenQMS support team worked closely with OrciMed to meet implementation timelines. A phased rollout began with the Training and Documents modules and eventually expanded to include the Issues and Change Control modules”. – Suman Maarisetty, Chief Executive Officer

Compliant Training Management for Hundreds of Users

Training management was the foundation of OrciMed’s implementation strategy. With hundreds of users, the team needed a reliable way to manage training records and demonstrate compliance.

“We didn’t want to be in a position where training wasn’t centralized. From the moment a new employee joins, everything is managed through ZenQMS”.

Every new OrciMed employee receives a walkthrough of ZenQMS, account access, and onboarding support from internal administrators. Once familiar with the system, users can confidently access their assignments and training history.

“Once they’re given a walkthrough on how the system works, they know how to access it. It’s very easy for the new users to understand.”

"For Savita and the quality team, training records – including assignments, document uploads, and compliance reports – can be easily pulled during audits and regulatory inspections." – Suman Maarisetty, Chief Executive Officer.

“Everything from training assignments to compliance reports lives in the system. It’s very straightforward to access when needed.” With over 300+ active users, OrciMed’s sound onboarding process, paired with an easy-to-use quality management system, makes it easier for new employees to get up to speed. Most users require little to no retraining after the initial walkthrough, which frees up time for Savita and the rest of the Quality team to focus on other core components of quality management.

Confident Change Control and Deviation Management

Once training and document modules were in place, OrciMed launched the Issues and Change Control modules with support from ZenQMS implementation managers. A sandbox environment allowed users to explore functionality and provide feedback before the new modules went live.

“We gave users access to a sandbox environment to try things out and provide feedback. That made a big difference when we transitioned to production.”

Today, OrciMed actively uses ZenQMS for deviations, CAPAs, and change control requests. Workflows are designed around their real-world processes.

“We have CAPAs and deviations in the issues module now. The workflows are very easy to use – the sequence is simple and intuitive.”

OrciMed continues to evolve and refine its configurations, adding improvements like cancellation steps for deviations that shouldn’t proceed through a full workflow. The configurability of ZenQMS enables the OrciMed team to focus on continuous improvement by adapting their workflows as processes mature.

ZenQMS Helps Keep OrciMed Audit Ready, Every Time

Since implementing ZenQMS, OrciMed has completed multiple audits and global regulatory inspections. Across every engagement, ZenQMS has helped the team demonstrate compliance with confidence.

“We’ve had multiple audits, regulatory inspections and vendor qualifications. We’ve demonstrated ZenQMS during those inspections, and we’ve never had negative feedback… it gives auditors/ inspectors confidence. There’s structure, there’s traceability, and there’s no room for data manipulation."

ZenQMS provides OrciMed with structure and validation out of the box, helping reduce scrutiny from regulators and improving audit response times.

“Anytime there’s an audit/regulatory inspections, Savita or I notify our team and ZenQMS support. They’ve been very helpful.” – Suman Maarisetty, Chief Executive Officer, OrciMed

Maintaining compliance is critical for organizations like OrciMed. ZenQMS provides the structure, audit trails, and data security and compliance needed to stay inspection-ready.

A Quality Management System That Scales

For companies still relying on paper-based or manual quality management processes, Savita offers clear advice:

“With paper, you’re scattered. With ZenQMS, everything is structured.”

Moving to an eQMS that scales has reduced administrative burden, improved compliance, and raised confidence for the organization during audits.

“A validated electronic system speaks for itself. It reduces risk, improves efficiency, and gives auditors confidence that your quality processes are under control.

OrciMed’s team now manages quality more effectively across all functions and continues to grow its use of ZenQMS as its needs evolve.

Want to see how ZenQMS supports teams like OrciMed? Watch our 3-minute eQMS demo and get a preview!