What is Validation?
The short textbook definition of validation is: "Proof of Specified Performance".
It follows that a validation process requires; Specification, Performance and Means of Proof.
Who is responsible for validation?
The company using the process or system to be validated. There is no such thing as a validated system which can be delivered into a user company without any additional validation work being required.
The reason for this is that the most important part of the validation process is one of determining and proving the suitability of a purchased system for its designated function and, going forward, its continued appropriate use by the purchaser.
The ease of being able to carry out this process will define the validatability of the system. This will depend on the quality of the supplier's supporting documentation and procedures.
How is it done?
The first step in the validation process is a Risk Analysis to determine the impact of out of specification (OOS) measurements on patient care or drug delivery.
The outcome of this assessment will determine the rigour of the Validation plan which then needs to be created for the system.
In a Validation plan the user sets out the intended validation procedures for the process or system to be validated. This plan should describe the validation steps to be taken and define successful outcomes at each stage of the process.
The most common structure of the validation process is based on the performance of the following five Qualification steps:
- Specification Qualification.
- Construction Qualification.
- Installation Qualification.
- Operational Qualification.
- Performance Qualification.
How does Malvern Instruments help users to validate their systems?
- By having a Lifecycle documentation system for hardware and software development which conforms very closely to GAMP guidelines.
- By offering a level of OQ documentation which sets the standard for analytical equipment.
- By the provision of Quality Audit Standards and latices for the ongoing verification of the performance of systems and sample dispersion units.
What about 21 CFR part 11 compliance?
Malvern offers complete technical compliance with the requirements of 21 CFR Part 11 for the following products:
The 21 CFR Part 11 compliant variants of the software for these systems offers features such as multi-layer access, user group permission configuration, audit trails and Windows NT® - type security features such as continuous use monitoring and password ageing.
Owing to the size of the pharmaceutical user base for the Mastersizer 2000, the 21 CFR Part 11 compliance package not only offers a key to the 21 CFR Part 11 compliant features of the software but includes a binder containing preview copies of all the IQ/OQ documentation for the system including the sample dispersion units used in the pharmaceutical industry together with advice on 21 CFR Part 11 compliance and its optimisation. Advice is given on Performance Qualification and comprehensive information is included to assist with numerical validation and vendor qualification.
Remediation software for the Mastersizer legacy systems, Mastersizer S and Micro is also available.