pharma codebeamer X for Pharma Project Validation & Quality Risk Management

codebeamer X is your all-in-one tool to support pharmaceutical systems validation and quality management. Adopt science-based quality risk management, and apply a risk-based approach to computerized systems compliance. Automate the documentation of your quality risk management lifecycle with codebeamer X.

Enjoy gapless traceability, full change control & baselining, and rigorous process control. Use a preconfigured GAMP® 5 template to simplify adherence to GxP regulations and accelerate audits. Provide documented assurance that your systems are fit for their intended use with minimal costs.

FDA Title 21 CFR Part 11 Validation Kit

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Gedeon Richter Customer Success Study

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Intland's Tool Validation Package Template

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gamp-timeline codebeamer X for Pharma Project Validation & Quality Risk Management

What users benefit from applying codebeamer X 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 X to plan, visualize, and manage releases. Record individual team members’ working time spent on work items, manage assignments, and oversee performance. Rely on dedicated functionality for Roadmap management or Timekeeping, and define custom artifacts to suit your needs. Benefit from real-time reporting to make sure your processes are in line with your project definition.

Pharma Lifecycle Management

Enforce controlled, fully compliant workflows at every step of the way in your pharma projects’ lifecycle. Embed sophisticated approval processes in your workflows, and have codebeamer X 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-compliant Risk Management

Simplify the adoption of a risk-based approach to computerized systems compliance. Apply science-based Quality Risk Assessment in your pharma projects with ease. Assess, control, communicate and review risks with codebeamer X. Trace risk-related activities all the way through to validation. Have codebeamer X automatically create 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 X, 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 analyze the causes of unacceptable test results, and trace 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_quality_assurance_3_1-optimized codebeamer X for Pharma Project Validation & Quality Risk Management

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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 X‘s document management features to create documents with timestamped change control ensured, and share documents internally or externally. Ensure accurate version control on all your documents, and define custom workflows for them. 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.

baselining_and_history_3_1_2-optimized codebeamer X for Pharma Project Validation & Quality Risk Management

Reporting and Documentation

Conveniently access automatically recorded Audit Trail data in codebeamer X. 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 team members or executives 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. Manage quality audit & CAPA, and apply Quality by Design concepts in your pharma lifecycles. Demonstrate pharma risk management maturity. Connect standard requirements to work items and build airtight audit checklists to comply with GAMP, EU EMA, and US FDA regulations.

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. Implement a paperless, digital eQMS to comply with FDA Title 21 CFR Part 11. Validate codebeamer X‘s functionality around record generation, audit trails, and digital signatures to achieve regulatory compliance with optimal effort.

Increase user confidence in your systems

Assure patient safety through meticulous testing, and validate your pharmaceutical production systems with optimal effort. Automate documentation to guarantee and demonstrate that your GxP computerized systems are fit for the intended use. Rely on automatically created, customizable reports to simplify audits.

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Pharmaceutical Project Validation & Quality Risk Management Template

Intland-Retina-GAMP5-Template codebeamer X for Pharma Project Validation & Quality Risk Management

Orchestrate your pharmaceutical validation processes with codebeamer X’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.

codebeamer X’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.

codebeamer X’s Pharma GAMP® 5 Template contains:

Work items related to specifications, change requests, and bugs that cover the lifecycle

Hazard analysis functionality and risk-related artifacts that support the reduction/mitigation of hazards

Work items and processes to help you manage testing activities and releases.

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Gedeon Richter Customer Success Story

Find out how this multinational biotech & pharma company used Intland Software’s tool to validate its GxP computerized production systems.

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Making the Case for ALM in Pharma Project Management

Still relying on paper-based documents to manage systems validation? Here’s our recipe for success in going digital:

codebeamer X for Pharma Project Validation & Quality Risk Management