Special Expert Knowledge for Validation
Tekpak is a Trusted Packaging Line Automation Partner to many of the largest Pharmaceutical Companies in the world.
21 CFR PART 11
We have developed a deep understanding of the needs of our multi-national clients, in particular those in the pharmaceutical sector. Our project and Design teams all receive training regarding the regulatory requirements.
Our machines can be configured to assist with 21CFR Part 11 compliance. Our control systems can be specified to provide Audit Log, Time Synchronisation, Active Directory password protection, User Groups and permissions.
Communication Protocols
Our machines can be provided with Industry 4.0 ready options and can communicate with other devices and higher-level SCADA, MES and OEE systems using defined protocols such as OPC UA, LDAP, Ethernet/IP, Profinet, I-O Link, Modbus, TCP/IP etc.
Pharmaceutical and Biotech industry
- Validation services that consider ISO 9001, EU GMP Annex 11, FDA 21 CFR Part 210/211, and Part 11 — Electronic Records / Electronic Signatures (ERES)
- Computer system validation of Manufacturing Execution Systems (MES)
- Business Process Management and audit management, e.g. in preparation for an FDA audit
Medical Devices Industry
- Evaluation and optimisation of the quality management system and technical documentation according to Medical Device Regulation (MDR) and Regulation (EU) 2017/745 on medical devices
- Compliance Management Services in consideration of ISO 13485, FDA 21 CFR Part 820 and Part 11
- Electronic Records / Electronic Signatures (ERES)
- Audit management and support, e.g. as preparation for an MDSAP – Medical Device Single Audit Program
Your advantages
A Perfect Partner
We are specialists in the pharmaceutical validation area, with customers from small SMEs up to global players in the pharmaceutical industry’s top 10
Custom Configurations
Scalable to meet the requirements of all company sizes
Individual Adaptation
Customer-specific validation of the computer systems
Conformant Regulations
Compliance with the regulatory requirements of national and international directives
