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MVS Pharma documentation QMS Overview: Documentation is one of the most critical pillars of the EU Good Distribution Practice (GDP) framework. Every action, decision, control measure, and operational activity must be traceable through accurate, complete, and accessible records. At MVS Pharma GmbH, documentation is treated as a living element of the Quality Management System (QMS) – one that safeguards regulatory compliance, operational transparency, and product integrity across the entire supply chain.
Documentation Requirements Under EU GDP
EU GDP Chapter 4 requires that all records related to distribution operations be clear, accurate, legible, readily retrievable, and protected against alteration or loss. Controlled documentation ensures consistency, reduces risk, and provides evidence during inspections that all GDP principles are being applied as intended.
Key GDP expectations include:
- Approved and controlled documents (SOPs, forms, specifications)
- Real-time, accurate records of every GDP-relevant activity
- Traceability of processes, decisions, and product movements
- Retention of records for the defined regulatory period
- Data integrity aligned with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available)
MVS Pharma’s Documentation Control System
MVS Pharma GmbH operates a fully structured documentation management process using the MS Office Suite Professional–based Digital QMS. This ensures efficient, secure, and compliant document control throughout the lifecycle of every quality-related document.
- Controlled Templates and Standardized Formats
All documents, such as Standard Operating Procedures (SOPs), Work Instructions (WIs), forms, logs, reports, and quality agreements – use predefined, controlled templates. These templates ensure:
- Consistent layout and structure
- Inclusion of mandatory metadata (Document ID, Version, Author, Reviewer, Approver, Effective Date)
- Alignment with internal and regulatory requirements
- Secure Document Storage with Restricted Access
Documents are stored in controlled digital directories with access based on role and responsibility. Only authorized personnel may create, edit, or approve documents. Obsolete documents are archived in secure folders to maintain traceability.
Document Lifecycle at MVS Pharma
- Creation and Review
Documents are drafted by trained personnel and reviewed by the Responsible Person (RP) to ensure GDP compliance, operational accuracy, and regulatory alignment.
- Approval and Release
Final approval is granted by the CEO, reflecting top-management involvement in quality governance. Approved documents receive a unique Document ID and version number.
- Training and Implementation
Before a document becomes effective, relevant employees are trained according to the Training SOP. Records of training sessions are maintained within the Digital QMS.
- Periodic Review and Revision
Documents undergo scheduled reviews or updates whenever:
- regulations change
- processes are improved
- deviations or audit findings require amendments
- Older versions are archived, ensuring full revision history.
Comprehensive GDP Records Maintained at MVS Pharma
MVS maintains all GDP-relevant records in a controlled and traceable manner. These include:
Operational Records
- Goods receipt checks
- Quarantine and inspection records
- Temperature logs (daily logs + online smart monitoring system)
- Dispatch and transportation records
- Environmental monitoring records (temperature, humidity, alarm events)
Quality System Records
- Training records and training matrices
- Calibration and maintenance certificates
- Supplier and manufacturer qualification files
- Audit reports
- Deviations and CAPA records
- Change control documentation
- Management Review Meeting (MRM) minutes
- Returned goods and complaint handling records
Each record is maintained according to ALCOA+ principles and stored for the required retention period.
Data Integrity and Traceability: MVS Pharma Documentation QMS
MVS applies strong data-integrity controls to ensure all records are:
- attributed to the correct personnel
- created in real time
- protected against unauthorized modification
- backed up securely
- readily retrievable for inspections
These practices ensure compliance with EU GDP while supporting business continuity and operational excellence.
Conclusion
MVS Pharma GmbH remains committed to maintaining a transparent, traceable, and fully compliant documentation system that reflects the highest standards of EU GDP. Through controlled templates, secure digital management, rigorous review processes, and strong data-integrity principles, MVS ensures that every document and record contributes to the safety, quality, and reliability of our pharmaceutical operations.
