Computerized Systems Validation

We have on staff professionals in systems design, validation and Part 11 with Compliance Managers to assist you with equipment, packaging lines, PLC's, SCADA's, BAS, LIMS, MRP, and SAP systems. Some areas in which we can provide support are listed below:

Validation Master Plan
Vendor Audits
User Requirements Specification (URS)
Functional Requirements Spec. (FRS)
Technical Design Specification (TDS)
Requirements Tracability Matrix (RTM)
Source Code Review
System Startup & Commissioning
Installation Qualification
Operational Qualification
System Summary Report
Periodic Review



Procedures

Corporate CSV Guidelines
Change Control-Project and Configuration
Periodic Review of Computerized Systems



CSV Assessments, Audits, and Inventory

CSV Systems Compliance Audit
CSV Systems Inventory-Equipment and Instruments
Part 11 Assessments and Part 11 Systems Inventory
Compliance Assessments - Security, System Data Storage, Backup and Recovery, etc.



Network Qualification

It is important to understand the difference between Validation and Qualification when bringing a company wide network or a local production network into a state of control and a compliant state. A process is validated and equipment is qualified. Many new regulations have emerged; the EU GMP guide - Annex 15, ICH's Annex 18, 21 CFR Part 11, and others that correspond to qualification of the network infrastructure and the validation of the software that resides there. Recent regulatory action has brought to light the need to have clear separation of systems and understanding where one system ends and the next begins. Controlled configuration management and qualifying the data migration is important and will keep you away from a painful learning experience that some call "garbage in - garbage out". Setting up a system to assure a state of control, bring a network into a compliant state, and network qualification and related validation is our specialty.

We can assist in many areas; some of these are defined below:

Project Management activities and assisting with a compliance strategy
Qualification of the Network Infrastructure
Network Diagrams - Defining the system and its boundaries
Criticality Assessment - defining what systems and software should be validated based on business,
compliance, product and health risks.
Validation of the software applications and databases
Define the open/closed systems and validate accordingly.
Construct a quality system for you infrastructure operations - Directives, Policies, Guidelines, and Procedures.



Qualification & Developing Test Methods

Computerized Systems

System Test Plan
Installation and Operational Qualification
I/O Testing, Loop Testing, Proportional Integral Derivative (PID) Testing
Functional Testing, Backup Data storage Verification, Alarms, and Point

Destination Verification

Screen Graphics and Data Verification, Calculations Verifications
System Remediation & Deviation Resolutions
Review of Test Data and Final Reports

Software

Software Qualification Plan
Application Software Qualification
Code Reviews, Modular System Integration Testing
User Interface Testing
Password and Security Verification



Definition: Computerized System Validation (CSV)

Computerized systems for research, development, and manufacture of drugs and other new therapies have an enormous impact on the potential safety, efficacy, and quality of health care products and services. Regulators worldwide are striving to ensure that health care industries keep these computerized systems under documented management control.

Pharmaceutical and biotech professionals are confused about "how much is enough" in computer validation work. Many firms are losing valuable time and productivity as system teams try to figure out how to proceed in validation work. A standards-based approach is needed for CSV work to become a normal part of business in regulated environments, and The Compliance Group, Inc. has different systems ready for implementation depending on your specific needs.