Production in the pharmaceutical industry is both highly automated (through the use of automation systems) and rigorously controlled to ensure patient safety and product quality. This poses a variety of challenges to pharma developers. In addition to achieving high product quality and the least amount of waste possible, compliance with regulations and guidelines (most importantly the Good Automated Manufacturing Practice®) also needs to be ensured.
Intland’s Pharma GAMP® 5 Template, developed in collaboration with pharmaceutical automation experts Controsys Control Engineering Ltd., is preconfigured to help pharma companies, suppliers of production devices (automation technology and control systems), and system integrators achieve compliance with the requirements of GAMP® 5.
The Good Automated Manufacturing Practice® 5
As a comprehensive guide, GAMP® covers all aspects of computerized systems good practice and compliance throughout the lifecycle of complex pharmaceutical projects. It requires developers to focus on patient safety by ensuring product quality and data integrity throughout the lifecycle. GAMP® also calls for the use of a risk-based approach to quality, enabling developers to identify high-risk areas and focus on those while establishing a rationale for lower risk areas. Finally, the guide stipulates the need for item and process-based traceability throughout the entire pharma lifecycle.
In an environment as complex as a typical pharma development project, ensuring compliance with all of the above can cause a headache. That's exactly why Intland teamed up with Controsys to create Intland’s Pharma GAMP® 5 Template. This preconfigured project template comes with all the artifacts, user roles, and workflows you'll need to achieve compliance with the Good Automated Manufacturing Practice®.
Intland’s Pharma GAMP® 5 Template for Compliance
While preconfigured to enable use out of the box, Intland’s Pharma GAMP® 5 Template is flexibly customizable to make sure you can tailor it to your own development environment. This versatile project template leverages the market-leading capabilities of codeBeamer ALM to help you achieve high product quality, minimum waste, and compliance with GAMP®'s requirements.
The template comes with artifacts to support project management, including software and hardware development (requirements and other specifications, process control, QA & testing). Risk management is supported by specific GAMP®-compliant features, while efficient collaboration is ensured through the use of wikis and documents. Everything in codeBeamer is versioned, may be baselined, and automatically documented. Data from this documentation can then be easily fed into comprehensive reports. To learn more about the benefits of using Intland’s Pharma GAMP® 5 Template, watch our webinar recording, or download our pharma brochure: