ALM for Life Sciences & Pharma Development

Maintain focus on patient safety, product quality, and data integrity throughout the pharma development lifecycle with codeBeamer ALM. Adopt science-based quality risk management, and apply a risk-based approach to computerized systems compliance. Ensure comprehensive Quality Assurance and risk management including FMEA, all in one platform.

Automate the documentation of your quality risk management lifecycle with codeBeamer ALM. Enjoy gapless traceability, full change control & baselining, and rigorous process control throughout the lifecycle. Use a preconfigured template to achieve high product quality, minimum waste, and adherence to GxP regulations in pharmaceutical development projects. Provide documented assurance that your systems are fit for intended use with minimal costs.

FDA Title 21 CFR Part 11 Validation Kit

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Intland's Tool Validation Package Template

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gamp-timeline ALM for Life Sciences & Pharma Development

What users benefit from applying codeBeamer ALM in pharma product development?

Pharmaceutical end users
(production companies)

Systems Integrators providing services for pharma producers

Suppliers of automated systems including hardware and software for the pharma industry

Features for Pharma Development & GAMP compliance

Pharma Project Management

Maintain rigorous control over every stage of your pharmaceutical product development projects. Use codeBeamer ALM to plan, visualize, and manage releases using Gantt charts. Record individual team members’ working time spent on work items, manage assignments, and oversee performance. Use dedicated trackers for Roadmap management or Timekeeping, and define other custom artifacts to suit your needs. Benefit from real-time reporting to make sure your processes are in line with your Project and Verification Plan.

project-management-2 ALM for Life Sciences & Pharma Development

pharma-development ALM for Life Sciences & Pharma Development

Pharma Software and Hardware Development

Capture, define, and manage requirements in collaboration with all relevant stakeholders. Create a User Qualification Plan, and use preconfigured work items to manage system and software design specifications, functional and user requirements, and more. Ensure traceability between specifications and related tests. Benefit from automatic change control on all your artifacts, and trace work items across the lifecycle effortlessly. Monitor the execution of all tasks across hardware and software delivery.

Pharma Lifecycle Management

Enforce controlled, fully compliant workflows at every step of they way in your pharma projects’ lifecycle. Embed sophisticated approval processes in your workflows, and have codeBeamer ALM’s Review Hub automatically log any and all review activity. Use timestamped, fully compliant e-signatures as trustworthy, reliable, and equivalent alternatives to paper records as per FDA guidelines. Simply access and export activity reports to demonstrate adherence to quality standards.

gamp-risk-fmea-2 ALM for Life Sciences & Pharma Development

GAMP-compliant Risk Management & FMEA

Simplify the adoption of a risk-based approach to computerized systems compliance. Apply science-based Quality Risk Management (QRM) in your pharma projects with ease. Assess, control, communicate, and review risks with codeBeamer ALM. Conduct Failure Mode and Effects Analysis, and access a comprehensive FMEA worksheet. Use risk tasks to trace hazards to reduction/mitigation actions and to validation. Have codeBeamer ALM automatically create an accurate and complete documentation of your quality risk management lifecycle to simplify audits.

Pharma Quality Assurance

Define, manage, and monitor testing activities using GAMP®-compliant test artifacts. Build a sound Quality Management System in codeBeamer ALM, manage quality documents, and provide a single source of truth for quality lifecycle data. Adhere to your validation and quality plan through prioritized testing activities.

Easily fix the root causes of unacceptable test results, and trace these activities using Observations and Deviations work items. Follow and propagate modifications in your requirements whether after initial review or as a consequence of detecting deviations during testing. Be automatically notified of suspected links between changed items and other artifacts upstream or downstream. Access a full change history on all your items.

pharma-qa ALM for Life Sciences & Pharma Development

pharma-wiki-2 ALM for Life Sciences & Pharma Development

Wikis, Document Management

Ensure access to up-to-date information for all stakeholders throughout the pharma lifecycle. Create wikis to support collaboration and knowledge sharing. Rely on codeBeamer ALM’s document management features to create documents with timestamped change control ensured, and share documents internally or externally. Use the Intland Retina QMS plugin to implement a sound Quality Management System, and provide simple access to a shared and change-logged repository of documents.

Baselining and History

Simplify audits by providing compliance auditors and other internal and external stakeholders with a comprehensive overview of your projects’ history. Conveniently manage milestones in your pharma projects, and use baselines to enable “timetravel” to previous states. Browse or compare baselines to access rich historical data about artifacts, workflows, audit information, comments, tasks, etc. Trace changes back and forth to gain clarity in complex pharma development projects.

pharma-baselining-history-2 ALM for Life Sciences & Pharma Development

pharma-baselining-history-3 ALM for Life Sciences & Pharma Development

PHARMA-Report ALM for Life Sciences & Pharma Development

Reporting and Documentation

Conveniently access automatically recorded Audit Trail data in codeBeamer ALM. Filter data using custom reports, and use real-time reporting dashboards to information. Gain all-inclusive lifecycle insights with minimal effort. Set up, share, and export reports around risk and code traceability, development activities and performance, or testing procedures. Build custom reports, and automate the delivery of these reports right into the hands of those that need them.

Benefits for Pharmaceutical Product Developers

Science-based Quality Risk Management

Implement risk-based quality management throughout the lifecycle using a shared platform. Ensure patient safety, product quality, and data integrity in pharma projects. Comply with EU EMA and US FDA regulations. Demonstrate risk management maturity at audits with minimal effort.

Traceable, compliant e-sign-offs

Provide clarity and historical change control to your auditors. Ensure smooth auditability with controlled processes and timestamped e-signatures for compliant virtual sign-offs.

Increase user confidence in your systems

Assure patient safety through meticulous testing, and validate your pharmaceutical products with optimal effort. Automate documentation to guarantee and demonstrate that your systems are fit for intended use. Rely on automatically created test reports with custom-defined test metrics to simplify system handover between phases.

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Start your free 30-day trial of codeBeamer ALM in minutes. Download for Windows or Linux, or start a cloud-hosted SaaS evaluation, and you’re ready to go!

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Life Sciences & Pharma Project Management Template

Intlands-Pharma-GAMP5-Template-codeBeamer-Intland-Software ALM for Life Sciences & Pharma Development

Orchestrate your pharmaceutical product development processes in a quality-focused, integrated manner with Intland’s Pharma GAMP® 5 Template. Adhere to GAMP® guidelines, and maintain focus on patient safety, product quality, and data integrity along the lifecycle. Rely on built-in documentation and best practices to achieve compliance with the Good Automated Manufacturing Practice® 5.

Intland’s Pharma GAMP® 5 Template supports pharma companies, suppliers of production devices (automation technology and control systems), and system integrators in applying best practices in the management of computerized systems in a pharma environment.

Ensure high product quality, minimum waste, and compliance with regulations. Achieve optimal visibility on processes, traceability, and process control across the entire lifecycle. Apply science-based risk management, and report on traceability across the entire pharma project lifecycle.

Intland’s Pharma GAMP® 5 Template contains: