At CAD-IT Australia, we believe that implementing leading information technology can make an incredible difference in your business and its operations. Enabling businesses to prosper through product lifecycle management diversifies a company and strengthens Australia’s manufacturing industry and future. To ensure operational effectiveness and dependability, manufacturers and other automation users adhere to manufacturing regulations known as Good Automated Manufacturing Practice (GAMPⓇ 5). At CAD-IT Australia, we utilise the Codebeamer GAMPⓇ 5 Template for the Pharmaceutical and Medical Device Industry.
What is GAMPⓇ 5?
Although GAMPⓇ 5 is not mandatory legislation, it provides guidelines for companies to guarantee pharmaceuticals or medical devices are produced to the required quality standard. GAMPⓇ 5 integrates quality testing into every manufacturing stage, including facilities, equipment, materials acquisition, and staff hygiene, instead of testing quality control batches. Standard operating protocols (SOP) are strictly followed, which helps to guarantee the quality of manufactured products. Good Automated Manufacturing Practice guidelines assist in managing computerised and software-based systems in collaborative projects, which cut costs and project times, manage hazards and defects and benefit in effective change management.
To meet the requirements for GAMPⓇ 5, CAD-IT Australia is working with a platform called “Codebeamer”. PTC’s software Codebeamer is an Application Lifecycle Management (ALM) platform for advanced product and software development. Codebeamer’s sophisticated workflows, traceability, and transparency help to support regulatory compliance while coordinating hardware and software development processes.
What is the GAMPⓇ 5 Template?
The GAMPⓇ 5 Template enables the documented management of computerized production systems using PTC®’s Codebeamer technology. It supports pharma project delivery, systems validation, and quality management. The template helps apply a risk-based approach to GxP computerized systems management. Additionally, the system’s traceability, accessibility, and advanced document management across stakeholders help to simplify and accelerate audits. The template can be used out of the box, or you can map your processes and tailor the template to your organization’s needs. Also, the template defines custom workflows for all work items and documents and uses preconfigured or custom reporting options.
The GAMPⓇ 5 Template cuts costs and project times, identifies and manages hazards and defects, and enables effective change management in GxP-compliant pharmaceutical project delivery. Furthermore, the template reduces waste, implements systemic risk management, and achieves GAMP® 5 compliance with optimal effort.
How does Codebeamer assist your Project Validation & Quality Risk Management?
At CAD-IT Australia, we are experts in implementing and using innovative industry-leading technologies to their full potential. We believe in constant training and development to stay updated with technology changes and business automation. PTC’s Codebeamer helps create better products faster using mature and robust processes from initiation through to delivery, streamlining lifecycle management and creating automated business processes.
Below are the 4 typical use cases for the GAMP® 5 Template for Pharma and Medical Devices:
- Pharma Validation Process Management
- Quality Risk Assessment
- Quality Audit and CAPA Management
- FDA 21 CFR11 Requirements and Compliance Check
Why use Codebeamer’s GAMPⓇ 5 Template?
- Cuts project cycle times significantly
- Achieve paperless traceability in pharmaceutical/medical device projects
- Comply with the requirements of GAMPⓇ 5
- Integrates collaborative product lifecycle
- Simplify and accelerate regulatory audits
- Save resources by reducing human effort
CAD-IT Australia’s vision is clear – to provide digital solutions for real-world business challenges. We aim to achieve this by using the latest cutting-edge technologies partnered with superior services and extensive expertise. When experience and knowledge matter! Contact our team today to learn more about GAMP® 5 and how CAD-IT Australia can help implement its technologies for the success of your business.