21 CFR Compliance Solution for Pharma

Compliance Perfected, Quality Assured in the Smart Factory Landscape.

Our 21 CFR compliance solutions are a testament to our commitment to quality and regulatory adherence. By implementing our solutions, pharmaceutical companies ensure not only compliance with stringent standards

Features

Password Protection individual user Accounts
Password and User ID policy (Individual unique ID and Password, minimum length and strength of ID and Password)
After generation of user ID system shall ask for password change on first login
Automatically limit number of failed login attempts.
Automatically record unauthorized login attempts.
Electronically require users to change their passwords at regular intervals.
Automatically password protects computer/SCADA systems when idle for short periods.
255 User Levels (Operator/ Supervisor/ Manager/ Administrator etc)
System should track for all creations, modifications performed in the system (All activity should be logged between login and log out) with time and date stamp along with user details.
Each process of Electronic Signature should be electronically logged in audit trail with time and date stamp and user ID.
All critical hardware related errors and warning should be logged.
Time and date stamp change automatically, it shall be locked and not editable unless performed by authorized user (shall be defined through user rights).
HMI/SCADA system shall be designed in a way that user to record reason for change through use of authorized login / password to go ahead with changes.
Automatically record identity of individual who made change.
System shall prevent to modify or delete audit trail.
Report :- Audit , Alarm, Batch or Process types or as per customer requirements
Database Backup :- We provide Automatic Backup , Restore & Backup Data Report Options

Our Offerings

Basic HMI to 21 CFR Compliance based HMI Migrations

HMI to IPC Migration Solutions (SCADA or DCS Solutions)

OPC DA/UA Server/Client Solutions

Centralized Data Collection & Reporting Solutions

Benefits

Precision and Compliance

Our solutions guarantee meticulous adherence to 21 CFR standards, ensuring every product meets stringent quality criteria.

Reduced Risk

By minimizing human error, our automated systems significantly reduce the risk of regulatory non-compliance and associated penalties.

Enhanced Reputation

Assured compliance fosters a stellar industry reputation, instilling trust among clients and stakeholders.

Regulatory Expertise

We possess in-depth knowledge of pharmaceutical regulations, offering tailored solutions that navigate the complex regulatory landscape.

Real-time Monitoring

Our systems enable real-time monitoring, allowing swift corrective actions and ensuring continuous compliance.

Why Us

Tailored Solutions

We understand the unique needs of pharmaceutical companies and provide customized solutions that align with individual requirements.

Proactive Approach

We anticipate regulatory changes, ensuring our clients are always ahead in compliance, giving them a competitive edge.

Ensure Pharma Compliance Now

Streamline regulatory adherence effortlessly with our 21 CFR compliance solutions. Elevate quality standards while enjoying operational benefits. Contact us for a seamless pharmaceutical compliance experience.