How a Post-Market HCT/P Company Streamlined Compliance with Grand Avenue Software
Overview
|
Client |
Induce Biologics |
|
Products |
Tissue-based bioimplants regulated as 361 HCT/Ps (Human Cells, Tissues, and Cellular and Tissue-Based Products) |
|
Challenge |
Manual processes, limited backup and retention, and inefficient training documentation workflows |
|
Solution |
Implementation of Grand Avenue Software’s eQMS to digitize document control and training management |
|
Results |
Significant time savings, audit-ready processes, and improved confidence in compliance |
Client: Induce Biologics
Products: Tissue-based bioimplants regulated as 361 HCT/Ps (Human Cells, Tissues, and Cellular and Tissue-Based Products)
Challenge: Manual processes, limited backup and retention, and inefficient training documentation workflows
Solution: Implementation of Grand Avenue Software’s eQMS to digitize document control and training management
Results: Significant time savings, audit-ready processes, and improved confidence in compliance
Client Intro: Growing HCT/P Manufacturer
Induce Biologics is a mid-sized, post-market manufacturer of HCT/Ps operating in a tightly regulated environment. As the company grew, its paper-based quality processes—especially for document control and training—became increasingly burdensome. To reduce manual workload, meet FDA 21 CFR Part 11 requirements, and support future growth, Induce Biologics sought an electronic QMS that was easy to implement, scalable, and supported by a responsive customer success team.
The Problem: Manual Workflows and Compliance Risks
Before implementing Grand Avenue Software, the company relied heavily on manual, paper-driven processes for their quality operations. Key challenges included:
- Time-consuming document control and training workflows
- Difficulty tracking records and ensuring retention
- Lack of automation for commonly used processes
- Risk of non-compliance due to limited backup and audit trails
These inefficiencies were consuming valuable time and creating unnecessary risk during assessments and audits.
The Solution: Implementing Grand Avenue Software
The company chose Grand Avenue Software for its ease of use, strong validation documentation, and responsive support. The initial implementation focused on digitizing document control and training management.
Why Grand Avenue Software?
- Pre-built validation package met regulatory expectations
- Out-of-the-box functionality with easy configuration
- Responsive, high-touch support from the implementation team
- Clear implementation checklists that guided internal teams
“The out-of-the-box solution and ease in configuring our needs has been the highlight of our experience.”
— Dhruti Sheth, Quality Assurance Director, Induce Biologics
Implementation Approach
With support from Grand Avenue’s implementation team, the setup process was smooth and structured.
- Implementation Checklists: Step-by-step guides helped the team stay organized and on track
- Responsive Support: The company noted the exceptional service from the Grand Avenue team, calling out individuals by name for their ongoing responsiveness and problem-solving
- Scalable Plan: Initial modules included controlled documents and training, with plans to expand into supplier, equipment, and NCM management
The Results: Time Saved and Compliance Strengthened
The transition to Grand Avenue Software yielded immediate improvements in efficiency, oversight, and audit readiness.
Time Savings:
- Over 20 hours per week saved in managing document change orders
- Over 10 hours per week saved in training documentation and record management
Compliance Benefits:
- Full Part 11 compliance with electronic signatures
- Audit trails and system backups ensure data integrity
- Automated workflows for consistent execution and reduced manual oversight
- Easier reporting and monitoring of compliance activities
“GAS has enabled us to exponentially reduce our time spent in the manual processes for controlled documents and training management,” the quality director shared. “We are looking forward to the continued benefits and process improvements as we expand into new modules.”
Conclusion: A Scalable, Compliant eQMS
By transitioning to Grand Avenue Software, this HCT/P manufacturer eliminated burdensome manual processes and gained a scalable, audit-ready quality system. The software’s ease of use and exceptional support gave the internal team confidence in its implementation and future growth.
As the company grows, Induce Biologics is preparing to implement additional modules—supplier, equipment, and NCM management—building on a strong foundation with a partner they trust.
Frequently Asked Questions: Induce Biologics & Grand Avenue Software
Induce Biologics, a post-market manufacturer of tissue-based bioimplants regulated as 361 HCT/Ps, implemented Grand Avenue Software to replace manual, paper-based quality processes that did not meet FDA 21 CFR Part 11 requirements for electronic records. Grand Avenue’s eQMS digitized their document control and training management workflows, established audit-ready processes, and gave the compliance team significantly greater confidence in their regulatory posture.
Post-market HCT/P manufacturers like Induce Biologics operate in a tightly regulated environment where manual quality processes — paper-based document control, spreadsheet-driven training records, and limited backup and retention — create compliance risk as the business grows. An eQMS like Grand Avenue addresses these gaps by digitizing workflows, automating documentation, and maintaining the audit trail required for FDA inspections and ongoing compliance.
After implementing Grand Avenue Software, Induce Biologics saved over 20 hours per week in managing document change orders and over 10 hours per week in training documentation and record management. The greatest time reduction was seen in document control workflows, where the elimination of manual processes and paper-based approvals had the most immediate impact on the team’s capacity.
Yes. Induce Biologics, a mid-sized post-market manufacturer, implemented Grand Avenue Software to digitize document control and training management and reported significant time savings and improved compliance confidence after go-live. Grand Avenue’s eQMS is designed to be straightforward to implement, with a responsive customer success team that supports the transition without requiring major internal resources.