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Quick and efficient validation for compliant systems

Adherence to stringent regulatory requirements is mandatory in the life sciences sector. These regulatory requirements extend to software for life sciences, making validation essential. STAEDEAN Life Sciences Validation Toolkit ensures your ERP system meets intended use and performs reliably, enhancing product quality and patient safety.

Validation for pharma software involves establishing protocols, demonstrating compliance, and maintaining validation throughout the system’s lifecycle. Any modifications require re-validation, a complex process simplified by our toolkit. It provides comprehensive validation frameworks, templates, and documents aligned with GAMP 5 guidelines.

Using our STAEDEAN Life Sciences Validation Toolkit and a robust traceability matrix, your company can efficiently manage regulatory compliance, ensuring your Life Science ERP boosts operational efficiency while upholding the highest quality and safety standards.

Key Challenges

Limited resources
Inadequate skilled resources lead to insufficient testing and poor risk management, causing system failures, downtime, financial losses, and regulatory non-compliance.
Complex software and testing process
Software for life science is inherently complex and often requires dedicated solutions (sometimes customization as well), making testing particularly critical. Ensuring all features function per expectations while maintaining compliance and system integrity demands meticulous testing procedures.
Dynamic regulatory requirements
Regulatory guidelines evolve rapidly, making it challenging for your organization to keep up and remain compliant. Frequent updates, extensive testing and retesting, and detailed documentation make validation for pharma software a costly affair.

User requirements specifications (URS)

Obtain templates for system requirements including functional requirements, data needs, constraints, and acceptance criteria guiding system design and development.

Risk analysis

Get samples for risk identification, assessment, mitigation, documentation, validation protocols, and compliance assurance for comprehensive risk management.

Test scripts and qualification protocols

Verify equipment installation meets specifications, document installation details, ensure compliance with regulatory requirements, test critical components, and record results for validation purposes.
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Benefits

Strengthen risk management

Identify and mitigate the risks associated with system failures, data breaches, or compliance issues. Reduce the likelihood and impact of adverse events.

Simplify validation

Standardize validation with templates, samples, and test scripts. Automate the process to ease the testing burden.

Enhance efficiency

Validate pharma software to identify slow processes that need optimization and enable task automation, significantly accelerating operations and boosting efficiency.

Ensure regulatory compliance

Meet GxP guidelines with our test scripts and templates. Get complete support in meeting Computer System Validation (CSV) and Computer Software Assurance (CSA) guidelines.

Streamline test script traceability

Ensure user requirements are met using meticulous test scripts. Mitigate risks by tracing the relationship and interactions accurately.

Minimize downtime

Ensure business continuity by mitigating risks through a streamlined validation process. Mitigate the burden of re-validating the whole system.

Features

Efficient Testing

Efficient Testing

Optimize processes to validate software functionality and performance, ensuring it meets user requirements and regulatory compliance.

Detailed Documentation

Detailed Documentation

Create and maintain documentation based on GAMP guidelines and recommendations.

Risk Management

Risk Management

Recognize, assess, and prioritize the risks of your pharma software and ensure they are validated.

Change Management

Change Management

Track changes, assess their impact, and ensure the modifications are re-validated as per guidelines.

Traceability Matrix

Traceability Matrix

Maintain documentation that supports each requirement in URS is adequately tested.

Frequently asked questions

Can't find what you're looking for?

What is the GAMP5 category of your software?

Our software is GAMP5 Category 4 - Configurable solution.

How does your Validation Toolkit support the GAMP 5 Second Edition validation process?

STAEDEAN Life Sciences Validation Toolkit offers a set of templates and sample documents that support the customer to validate the software for life sciences, focusing on medium and high-risk features and business processes.

Being in the Cloud, how does your Validation Toolkit support technical validation?

STAEDEAN Life Sciences Validation Toolkit contains documents to guide you through the system's technical validation. We also provide the installation guide and ensure meticulous adherence to it.

Does your Validation Toolkit support technical validation for life sciences weighing and dispensing?

The Validation Toolkit for pharma software offers templates to support the installation qualification of life sciences weighing and dispensing modules and verify the connection with the scales. It does not support the installation qualification of a scale independently from the STAEDEAN Life Sciences Weighing & Dispensing solution.

Resource Center

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    Life Sciences Validation Toolkit Factsheet

    Streamline the validation process, reduce risks, and ensure ERP integrity and compliance using our life sciences-specific Validation Toolkit.
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    Understand the importance of Computer System Validation (CSV) and Computer Software Assurance (CSA) in life sciences and its role in ISO 9001 Certification.

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    Get to know the step-wise implementation of Computer Software Assurance (CSA) and how STAEDEAN can help you satisfy the FDA requirements.

    Why should you move to Cloud from an On-Premises ERP?

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    Moving to the Cloud? Read the blog to explore the opportunities and understand the necessity of thorough validation for Cloud ERP systems.
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