ERP System Validation:
Our team offers comprehensive validation services to ensure that your electronic systems, including software and hardware, are validated according to regulatory standards. This includes Installation Qualification, Operational Qualification, and Performance Qualification.
These validations are paramount to ensuring that organizations can rely on their ERP systems for data accuracy, operational excellence, regulatory compliance, and informed decision-making.
Gap Analysis
We conduct a thorough gap analysis of your existing electronic systems, software, and procedures to pinpoint areas where compliance with 21 CFR Part 11 is lacking. Our assessment includes a review of data security, audit trails, electronic signatures, and validation protocols.
GAP analysis evaluates an organization's existing processes and systems against the regulatory requirements of 21 CFR Part 11. GAP analysis reinforces the quality of electronic records and signatures, promoting the reliability, security, and authenticity of data.
21 CFR-Part 11 Compliance
Our service offerings for 21 CFR Part 11 compliance are designed to equip your organization with the knowledge, tools, and expertise needed to meet regulatory requirements and maintain the highest standards of data integrity and security.
The pharmaceutical and life sciences industries are characterized by stringent quality and regulatory requirements. Among these, 21 CFR Part 11 holds a prominent place.
SOP Development
We assist in the development and implementation of Standard Operating Procedures (SOPs) and policies that align with 21 CFR Part 11 requirements. These SOPs cover areas such as electronic record management, electronic signature usage, and data integrity practices.
The pharmaceutical and life sciences industries operate within a highly regulated environment where compliance is non-negotiable. In this context, the development of Standard Operating Procedures (SOPs) is crucial, especially when it comes to adhering to 21 CFR Part 11.
21 CFR Part 11 Training
We offer training programs and workshops for your staff to ensure they understand the principles of 21 CFR Part 11 compliance. Training covers topics such as data integrity, electronic record handling, and the proper use of electronic signatures.
Training provides an in-depth understanding of the specific requirements of 21 CFR Part 11, including electronic record keeping, electronic signatures, data integrity, and audit trails. Training prepares organizations to undergo audits with confidence, knowing that they meet 21 CFR Part 11 standards.
Configuration Validation:
Ensuring that the ERP system is correctly configured to align with the organization's specific needs. This includes validating configurations, Account mapping, customizations and inter-modules settings.
Configuration validation involves a comprehensive review system settings and configuration mappings to ensure that it aligns with the specific requirements of 21 CFR Part 11.