ERP Solution for FDA-Regulated Industries
FDA regulated industries need an ERP solution that helps them remain compliant.
The Copley FDA Extended ERP Solution is an extension of Infor SyteLine Industrial to support the required compliance mandates for all FDA regulated industries. These extensions address the key functional areas where transaction records are required to remain in compliance with the 21 CFR Part 11 regulation and support ISO 13485 and GAMP 5 guidelines.
Industries Benefitting from Copley’s FDA Regulated Solution
The FDA regulated industries we work with vary from medical device manufacturers to food and beverage manufacturers.
- Medical Devices
- Prosthetics
- Compound Pharmaceutical
- Organ Regeneration
- Cosmetic Products
- Food & Beverage
- Ophthalmic Products
- Environmental Safety Equipment
- Stem Cell Solutions
- Diagnostic Testing Solutions
- Physical Rehabilitation Equipment
FDA Regulated Solution Features
The Copley FDA Extended solution has several key features to ensure compliance.
DMR/DHR
Full Lot & Serial Tracking
Approved Vendor Management
eSignature Controls
CoA & CoC Report for Manufactured Lots
FDA Validation Tools
Copley’s FDA Extended ERP solution ensures validation of the software’s intended use while exposing a company to their risk of FDA audit non-compliance if not properly executed. Our experience with FDA requirements and manufacturing best practices for clients has led to our development of these templates and an implementation methodology to ensure FDA compliance.
Process Templates
If your Regulatory personnel have experience in leading an FDA Validation project that included the back-end ERP software, then you can leverage your internal resources by having them take the lead in the process. To support their efforts and to maximize their efficiency, the Copley FDA Validation Templates provide guidance to streamline their workload.
OPQ Scripts
The extensive, detailed documentation required in support of your OPQ report can be burdensome to your organization, with errors requiring significant rework. The operational and performance validation scripts, developed specifically for the Infor Cloudsuite solution, help you reduce the effort, and lessens the risk of errors by facilitating compliance with these stringent requirements.
Support & Services
Implementing an ERP solution for organizations that fall under FDA regulations must go through a validation process. The validation determines, defines, governs and documents the formal testing of Good Manufacturing Practices (GMP) and relevant activities pertaining to the definition, production and delivery of regulated products
and services.
Our FDA Regulated Clients
Our FDA Regulated Clients
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Case Studies
Triangle Accelerates Growth With Copley’s FDA Extended ERP Solution
Triangle Manufacturing Company Inc. was founded in 1955 and continues to bring to life a wide range of medical instrumentation and implantable devices at a time when reliable sourcing is more important than ever. Triangle’s work impacts almost every part of the human body, demanding a level of precision and quality unlike any industry.
Copley’s FDA Regulated Resources
Quanterix
BionX Medical Technologies
HART (Harvard Apparatus)