What?

Choosing a validation solution is based on the following requirements that’s typical for any organization:

• Capable of maintaining electronic records and electronic signature
• Provide an efficient way to maintain validation requirements, functional and design specifications.
• Based on validation system (or process) criticality, the application helps to do risk assessments and management. The key is to adopt the risk based approach to complete the validation process.
• Way to choose the testing methods (scripted & unscripted), create test strategies (test plans & test runs) to complete the testing. The test strategies should also follow risk-based approach and ensure the system is validated (tested) against all identified risks in the system.
• An option to integrate with third party applications, the core system should be an open system should allow the communication between organization’s current applications and any other that would be introduced in the future. For example, the organization may want to integrate existing QMS or Change control system with the validation software.

How?

How a validation solution that would be fulfil organization requirement for a comprehensive system and that meets above requirements?

• User-friendly system, which replaces manual paper based systems and handwritten signatures.
• An option to execute the validation projects in traditional V-process model or Agile way.
• Easy way to handle pre-defined templates to capture the validation requirements and specifications.
• Online system that allows user to have discussion on the requirements before vendor evaluations.
• An efficient risk management system that allows to identify & document the Risk Probability and mitigation plans for all identified risks. Also way to identify and document plans to handle residual risks.
• User defined workflow that allows electronic records go through multiple reviews and approvals with electronic signatures.
• Audit trail feature with detailed reporting that would fulfil both organization as well regulatory requirements.
• An option to define comprehensive test planning and execution. The validation solution should allow capturing screenshots/videos as records for the test execution.

Why?

An efficient solution should address the purpose of moving to new validation software and bring the value to organization in terms of improving productivity and bring good RoI value.

• Solutions that support total end-to-end processes and maintain data coherency and integrity.
• Allows implementing the highest level of compatibility with the business process without compromise of any regulatory requirements.
• Having digital data enables remote teams to connect and contribute during the validation.
• This solution will be an essential part of the quality management system, which enables the organization to simplify administrative processes, managing equipment use, maintenance and calibration and cleaning of equipment and rooms.
• To improve the quality of data for analytics and reporting and support the release of product to market.
• Enables clear and transparent way of validation process right from defining the problem statement to validation summary report.
• Enables quick data access and show the test scripts and execution to the auditors. Allows any auditor to trace a specific requirements, its related risk , test cases, actual results during the execution, electronic review process and audit trial.