ERP Solution for Pharmaceutical Manufacturing
Pharmaceutical manufacturing organizations have quite a few business challenges that require special attention. These include extensive compliance requirements, complex supply chain for restricted substances, and inventory turn-around times for perishable goods.
To always keep the manufacturing of your pharmaceutical products operational, you will need an ERP solution designed for your specific industry.
As the pharmaceutical industry is one of the most regulated industries around the globe, the FDA has stringent guidelines in place to ensure all software complies with good manufacturing practices. Remaining compliant is absolutely a necessary factor when implementing an ERP system.
A pharmaceutical ERP should control the processes of a pharmaceutical company and ensure compliance at every level. A pharma ERP is responsible for every stage of the process while following the guidelines set from GLPR and other compliance manufacturing requirements.
Some of the compliance requirements required for a Pharmaceutical ERP Solution include:
- Good laboratory practice regulations
- Lot & serial tracking
- Bar code label requirements
- Inventory management
- Contract manufacturing arrangements and outside processing
- Formula management
- Batch master files
- Electronic Batch Records
- Quality Management System for paperless operations
FDA Regulated Solution Features
The Copley FDA Extended solution has several key features to ensure compliance.
EBR
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 SyteLine 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
CONTACT US TO
Learn More About Our Solutions
Case Study
Pine Pharmaceuticals Meets FDA Requirements with Copley’s FDA Extended Solution
Pine Pharmaceuticals provides pharmaceutical compounding, including specialized sterile formulations serving ophthalmologists, retinal specialists, hospitals, medical practices and clinics. Their sterile compounded preparations are made to order and formulated using cuttingedge technology and industry-leading quality assurance practices.
Copley’s FDA Regulated Resources
Quanterix
BionX Medical Technologies
HART (Harvard Apparatus)