Ingenium
Projects
At Ingenium, we pride ourselves on delivering tailored compliance solutions that help clients navigate complex regulatory landscapes. Our proven track record spans various industries and compliance domains, ensuring not just adherence to standards, but also process efficiency and business continuity.
INGENIUM
1. GAP Analysis & Remediation for CSV Compliance
A leading life sciences organization approached us to review their existing Computerized System Validation (CSV) processes.
Our Approach:
Conducted a thorough assessment of their current CSV Quality Management System (QMS).
Identified gaps between their current practices and FDA regulatory expectations.
Developed a prioritized remediation plan with clear action steps, timelines, and ownership.
Impact:Enabled the client to achieve full CSV compliance ahead of their scheduled audit.
Reduced revalidation effort by streamlining redundant processes.
INGENIUM
2. End-to-End CSV Lifecycle Management
For a pharmaceutical manufacturing client implementing a new laboratory management system, Ingenium provided comprehensive CSV support from start to finish.
Our Approach:
Designed the validation strategy in alignment with GAMP 5 and FDA guidelines.
Created and executed validation protocols (IQ, OQ, PQ).
Delivered complete documentation for audit readiness.
Impact:System went live without compliance findings.
Provided a repeatable validation framework for future projects, saving the client significant time and cost.
INGENIUM
Global Audit Support (FDA, MDSAP, CFDI)
We partnered with a medical device manufacturer preparing for multiple global regulatory audits, including FDA, MDSAP, and CFDI.
Our Approach:
Conducted mock audits to identify and close compliance gaps.
Prepared detailed evidence packages for each standard.
Trained internal teams on audit protocols and documentation handling.
Impact:All audits were passed successfully with minimal observations.
Improved the client’s ongoing readiness for future inspections.
INGENIUM
SOX IT General Controls Implementation
A publicly listed technology company engaged Ingenium to strengthen its SOX ITGC framework to meet financial reporting compliance requirements.
Our Approach:
Reviewed and documented all existing IT controls related to system access, change management, and data security.
Designed additional controls to address identified weaknesses.
Supported internal and external auditors in testing control effectiveness.
Impact:Achieved SOX compliance within the financial year-end deadline.
Reduced audit issues by over 40% compared to the previous year.
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Ingenium
Our Clients
Ingenium has had the privilege of partnering with some of the leading organizations in life sciences, pharmaceuticals, healthcare, and compliance. Our client base reflects our commitment to quality, trust, and delivering measurable results.
Accuray
Supported compliance initiatives for a global leader in radiation oncology solutions, ensuring adherence to FDA and international regulatory standards.
Genpact
Partnered with a Fortune 500 professional services firm to deliver scalable compliance frameworks, aligning IT General Controls (ITGC) with SOX requirements.
FDAQRC
Provided consulting and validation services to a specialized compliance and quality consulting firm, reinforcing their client engagements with robust CSV and audit support.
RxCloud
Assisted a next-generation cloud-based healthcare platform in meeting stringent data integrity and regulatory requirements across GxP environments.
IQVIA
Collaborated with a global leader in advanced analytics, technology, and clinical research to strengthen CSV processes and support regulatory submissions.
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- +91 98805 99229
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