Benefits at a glance
Formally develop scripts and test routines to verify the ERP system and business processes are functioning as they should.
User Acceptance Testing
Ensure the software can handle required tasks in real-world scenarios.
Make certain you are compliant and stable through every upgrade.
Ensure that the development of all your processes are well-documented, traceable to a specific originator, and have an associated audit history.
Accept required electronic signatures in multiple areas of Deacom to ensure compliance with the FDA requirements.
Allow for quality procedures to be monitored and controlled.
- Diligently adhering to 21 CFR Part 11 enhances data reliability, traceability, and authenticity.
- Efficiently implementing a validated ERP system like Deacom simplifies the validation process and helps meet regulatory requirements.
- Effectively utilizing features such as digital signatures, secure access controls, and comprehensive reporting offered by Deacom ERP software ensures compliance with 21 CFR Part 11.
- Demonstrating compliance with 21 CFR Part 11 instills confidence in your operations and enables you to pass audits smoothly, showcasing your commitment to regulatory standards.
See it in action
Deacom ERP equips manufacturers with built-in tools for FDA's 21 CFR Part 11 compliance. With native functionality, companies can regulate processes and utilize electronic signatures to track transaction details like timestamps and user IDs. Watch this video showcasing how Deacom ERP ensures compliance without the need for additional external software or customizations.
How to address 21 CFR Part 11 validation
Ensure system functionality by formally defining elements, developing validation scripts, verifying data security and audit logs, and increasing record-keeping integrity.
Record Generation Policies
Streamline your record retrieval processes by implementing efficient methods, while documenting changes, iterations, and required signatures/approvals for thorough traceability.
Ensure Access to Audit Trails
Ensure comprehensive documentation of processes and procedures with traceability and an unmodifiable, automatically generated historical audit trail for thorough compliance and record integrity.
Allow for quality procedures to be monitored and controlled by ensuring documents are reviewed by specified individuals and they meet certain requirements before they are signed off.
Enforce Security Controls
Require a unique login and password for every user and ensure final records should are set with read-only permissions.
Give an administrator complete visibility and control over the use of these signatures across the system and provide a means to create and cancel signature requests as well as set the locations where signatures can be used to guard against fraud.
Want more information about 21 CFR Part 11 compliance?
By building upon a strong foundation, Deacom’s streamlined process for validation has proven to greatly impact the ease of validation for our customers in the medical device and pharmaceutical industries. Our ERP software includes the built-in tools necessary to assist you with this process and provide you with the most efficient means of meeting the requirements of 21 CFR Part 11 validation.
Take the next step towards meeting compliance by filling out this form. Our team is ready to assist you in harnessing the power of our ERP solution and guiding you through a seamless validation process.