Pharma Competency
Modular 21 CFR Part 11 Compliant Control Systems
- Audit trail enabled
- Secure user access
- Time synchronisation
- Data integrity focused
Control Systems Built for Regulatory Compliance
Tekpak designs and implements packaging automation systems that support 21 CFR Part 11 compliance, ensuring secure, traceable, and controlled electronic records across production environments. Our approach combines control system architecture, software configuration, and system integration to meet the requirements of regulated industries such as pharmaceuticals, biotech, and medical devices.
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
Core 21 CFR Part 11 Compliance Capabilities
Our systems are designed to support the key requirements of compliant electronic records and system control:
Audit Trail & Data Logging
Comprehensive audit trails capture system events, operator actions, and changes to support full traceability.
User Access & Permissions
Role-based access control ensures only authorised users can interact with the system.
Time Synchronisation
System-wide time synchronisation ensures accurate, consistent, and auditable records across all connected systems.
Data Integrity & Security
Systems are designed to maintain the integrity, accuracy, and security of electronic records.
Communication & Integration
Control systems support communication with SCADA, MES, and ERP platforms, ensuring seamless data flow across production environments.
Active Directory Integration
User management can be integrated with Active Directory, enabling centralised authentication and access control.
Control System Architecture for Regulated Environments
Tekpak delivers control systems that support compliant operation through structured software and hardware design.
- PLC and HMI-based control systems
- Secure user authentication and access layers
- Integration with plant-level systems (SCADA / MES / ERP)
- Configurable software architecture aligned with compliance requirements
- Support for validated system deployment
Built for Regulated Manufacturing Environments
Our systems are designed to support industries where compliance, traceability, and secure data handling are critical:
Pharmaceutical & Biotech
Supports validation aligned with EU GMP Annex 11, FDA 21 CFR Part 210/211 and Part 11 (ERES), including computer system validation for MES, audit preparation, and business process control.
Medical Devices
Designed to support compliance with MDR (EU 2017/745), ISO 13485, and FDA 21 CFR Part 820 & Part 11, including quality system optimisation, electronic records (ERES), and audit readiness (MDSAP).
Ensuring Data Integrity and System Trust
21 CFR Part 11 compliance ensures that electronic records are secure, traceable, and reliable. This is critical for maintaining product quality, meeting regulatory requirements, and ensuring audit readiness across pharmaceutical manufacturing environments.
The Tekpak Advantage in Regulated Environments
A Trusted Validation Partner
Deep expertise in pharmaceutical validation, supporting projects from SMEs to global manufacturers.
Custom System Configurations
Flexible and scalable solutions designed to meet specific operational and regulatory requirements.
Customer-Specific Adaptation
Systems tailored to individual validation needs, including software, control systems, and compliance frameworks.
Regulatory Compliance Built-In
Designed to meet national and international regulations, ensuring audit readiness and long-term compliance.
Ensure Your Systems Are 21 CFR Part 11 Compliant
Our team can help design and configure packaging automation systems that meet regulatory expectations and support compliant production.