Zamann Pharma Support logo

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Request an appointment now

Tag: Validation

TrackWise System – General Routine Support
Computerized System Validation

EU Annex 11 Explained: Ensuring Data Integrity in Pharmaceuticals

Pharmaceutical firms must prioritize data integrity and robust procedures to meet FDA and EU regulatory expectations. Understanding their detailed guidelines is vital for compliance and data quality. Successfully navigating these regulations requires mastering FDA and EU requirements, including best practices for data management. Companies should dedicate resources to implementing data integrity principles from both FDA and EU guidance.

Read More »
April 14, 2025
The validation process confirms that SaMD meets predefined specifications and performs reliably under real-world conditions, making it a cornerstone of compliance and quality assurance.
MD/IVD Regulations

SaMD Risk Management in Validation

The rise of Software as a Medical Device (SaMD) has transformed healthcare. Discover validation requirements, key standards, and best practices to ensure SaMD compliance and performance.

Read More »
November 25, 2024
The success of your regulatory audit largely depends on how well-prepared and detailed your validation documentation is
Process Validation

Tips for Validation Documentation in Regulatory Audits

Learn key best practices for developing thorough validation documentation to enhance the effectiveness of regulatory audits. Following these practices will help ensure your processes comply with industry standards, boosting both credibility and operational integrity.

Read More »
October 14, 2024
A Validation Master Plan (VMP) details the strategy for validating pharmaceutical manufacturing processes and equipment.
Equipment Qualification

Validation Master Plans (VMP) in Equipment Qualification

A Validation Master Plan (VMP) is essential for pharmaceutical equipment qualification, serving as a roadmap for validation activities. This guide outlines the VMP process, necessary documentation, and steps for creating an effective VMP to ensure regulatory compliance.

Read More »
October 2, 2024
The Design Qualification (DQ) process involves several key steps to ensure that equipment is suitable for its intended use
Equipment Qualification

Design Qualification: Steps for Effective Implementation

Design Qualification (DQ) is a critical step in the pharmaceutical industry’s equipment qualification process. This stage ensures that equipment meets regulatory and operational requirements before installation and production. Learn about the DQ process, necessary documentation, and challenges in achieving compliance.

Read More »
September 30, 2024
Computerized System Validation

Agile Meets GAMP 5: Streamlining CSV

Explore the integration of Agile methodology into Computer System Validation (CSV) guided by GAMP 5 principles. This approach offers enhanced flexibility, faster validation, and improved compliance, ensuring your software systems meet regulatory standards efficiently.

Read More »
July 31, 2024
Cleaning Validation

Cleaning Validation: 8 Steps for FDA Compliance Success

Cleaning validation is crucial for FDA compliance in pharmaceutical and food industries, ensuring equipment cleanliness to prevent contamination. It involves meticulous planning, execution, and documentation to verify effectiveness and consistency. Failure to comply can lead to compromised product quality, recalls, and damage to brand reputation.

Read More »
July 17, 2024
Computerized System Validation

What is GAMP 5 Guideline? Checklist for GAMP 5 compliance

GAMP is the acronym used to summarize the term “Good Automated Manufacturing Practices“. These are a compilation of recommendations published by the International Society for Pharmaceutical Engineering (ISPE) in the form of a book to provide guidance on the compliance of computerized systems in regulated industries.

Read More »
April 8, 2024
Zamann Pharma Support logo

Siedlerstraße 7 | 68623 Lampertheim, Germany

Zamann Pharma Support

Consulting Services

TerraTrust

Pharmatching

Pharmuni

Information

Privacy Policy

Imprint

Glossary

Need Help?

Request an appointment

info@zamann-pharma.com

Contact us

View Zamann Pharma Support GmbH profile on SAP Business Network Discovery

© 2025 - Zamann Pharma Support