Solution Overview
Purpose
REST ASSURED! CSV™ is a complete computer system validation solution developed to produce documented evidence that computerized systems will, in accordance with the GMP requirements, consistently perform as intended when brought into use. By choosing REST ASSURED! CSV™ you will not only ensure full compliance of your computerized systems with the appropriate international validation rules and standards. You may also rest assured that optimal effectiveness and efficiency of the validation process itself will be achieved through the implementation of risk management tailored to the quality requirements of your application, and through the use of methodology-based testing solutions evolved during years of real world experience in similar implementation projects.
Scope
REST ASSURED! CSV™ addresses prospective as well as retrospective validation of all types of GxP regulated computerized systems used in and supplied to the life sciences industry. Some examples of such systems are:
- IT systems, such as: LIMS, MRP II, inventory management systems, dispensing systems, document management systems
- Process Control systems, such as: BMS, HVAC, DCS, SCADA, HPLC, packaging machines.
These systems contain software belonging to either or all of the categories: standard, configurable and customizable, or bespoke.
REST ASSURED! CSV™ takes into account the current GxP life science requirements as specified in:
- US Codes of Federal Regulations (CFRs) covering GCP, GLP, GMP, and medical devices
- US CFR regulation 21 CFR Part 11
- GAMP 4, GAMP Guide for Validation of Automated Systems
- PIC/S (Pharmaceutical Inspection Convention/ Pharmaceutical Inspection Co-operation Scheme) Guidance
- EU Directives laying down the principles and guidelines of good manufacturing practices in respect of medical devices and medicinal products for human and veterinary use
- International Conference on Harmonization (ICH) guidelines
- ISO 14971:2000 Medical Devices – Application of risk management to medical devices
Methodology Highlights
How much validation evidence is required?
Validation is defined in the Good Manufacturing Practice Guidance of the World Health Organization, WHO, as “the establishing of documented evidence which provides a high degree of assurance that a planned process will consistently perform according to the intended specified outcomes”.
The level of validation should depend upon the potential risk posed by any computerized system to product quality or health of human beings and animals. Documented requirements analysis and risk assessment define the scope of evidence required to demonstrate that the system has been validated for the intended use.
REST ASSURED! CSV™ follows the risk assessment guideline defined in the GAMP 4 guide for the validation of automated systems. In addition, we use REST ASSURED! ER&S™ for the management of risks to electronic records and signatures associated with a computerized system.
What procedure do we follow while performing prospective validation of computerized systems?
For the validation of any computerized system prior to its deployment for the distribution of a new product or batch of an existing product, we adopt the following prospective validation procedure:
- We identify the GxP regulated system(s) to be validated
- We perform risk assessment based on the User Requirements Specification (URS)
- We perform, if necessary, supplier assessment
- We prepare a Validation Master Plan (VMP) outlining the planned tasks and the expected outcomes of the validation
- Based on the VMP, we prepare the quality and the project plan
- In the Design Qualification (DQ) phase we conduct design reviews at each level of design specifications, and we set up a traceability matrix to be updated through all validation phases
- We complete the DQ by writing a DQ summary report documenting the outcomes of the review process and confirming the design has been satisfactory
- Then we perform Installation Qualification (IQ) by documented verification that the system has been installed and tested according to written and pre-approved specifications and installation plan
- We complete the IQ by writing an IQ summary report documenting the outcomes of the installation process and confirming the installation has been successful
- Our next task is to perform the Operational Qualification (OQ) through documented testing to confirm that operations of the system consisting of hardware as well software function as specified under normal operating conditions taking into consideration realistic stress conditions created by alarms, error-handling etc.
- We complete the OQ by writing an OQ summary report documenting the outcomes of the testing process and confirming that individual components and systems are capable of operating within established limits and tolerances
- Our next task is to perform the Performance Qualification (PQ) through documented testing to confirm that the system operates in the live environment in accordance with the pre-defined and approved acceptance criteria.
- We complete the PQ by writing a PQ summary report documenting a brief summary of the activities and outcomes of the PQ process and confirming that the system performs in the live environment satisfying the URS
- Finally, we prepare the validation final report summarizing the entire validation project, measuring its ultimate success with reference to the expectations laid out in the Validation Master Plan, and documenting acceptance of the validated system by the user and Quality Control.
What procedure do we follow while performing retrospective validation of computerized systems?
For existing systems which were not or only partly validated in accordance with the principles of prospective validation (see above), we ensure that the following retrospective validation procedure is adopted:
- Creation of an experience report on the past operation of the system
- Assessment of the completeness and quality of existing documentation against the regulatory and company policy requirements
- Conduction of a risk analysis to determine the GxP-relevant impacts on product quality and safety of human and animal lives, and, if necessary, definition of remedial actions
- Creation of missing or updation of existing documents, if required
- Testing of the GxP-relevant components of the system based on the documentation
- Releasing the system implementing, if necessary, additional organizational QA measures
- Freezing the system status, or developing it further, if necessary, according to the prospective validation procedure
- Creation of a validation report
Integrative Testing Automation
Automated testing tools are an integral part of the REST ASSURED! CSV™ Methodology. Whenever appropriate, Tesnet Group uses the market’s leading automated testing tools, augmented by our proprietary and unique SMART Functions™, which are an elaborate set of functions and add-ons allowing us to maximize the effectiveness of market-ready tools, and to accelerate the testing process.
By using automated testing tools, together with Tesnet Group’s SMART Functions™, you’ll enjoy shorter implementation time and increased test coverage, and cut human resources significantly
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