Founded in 1998, R.D.McDowall Limited is responsible for compliance and testing activities within Bob McDowall's expertise and covers areas such as:
Services are tailored to a client’s specific requirements rather then provide an off-the-shelf service.
We have over 15 years experience of validating computerised systems that can be applied to solving client problems. We can provide expertise to the overall validation of any computerised system in research and development clinical and non-clinical functions as well as manufacturing laboratories.
Qualification of analytical equipment and computerised analytical systems in pharmaceutical and biotechnology laboratories. This service can be performed as either an outsourced service where we will carry out the majority of work or alternatively we can write the testing documentation and train your staff to qualify your equipment.
Migrating data from one application version to another, one platform to another or one system to another needs to be considered to ensure readability and availability of electronic records over the defined records retention policy. Formal retirement of computerised system components may also be required and we have expertise in this area to complete the life cycle of any computer.
QualifyPLUS® documentation for specification, installation and qualification for network components plus procedures to develop and operate a qualified network to support all validated applications.
The QualifyPLUS® methodology is a combination of generic documentation and consultancy aimed to reduce the overall time needed to validate any chromatography data system used in a regulatory environment plus training the users to maintain the validation in the operational environment. QualifyPLUS® has been used for both prospective and retrospective validation, including 21 CFR 11 requirements, of all major CDS systems.
All documents are individually customisable to meet your laboratory’s ways of working making them specific for your organisation rather than using an off-the-shelf package that may not cover all regulatory issues or your laboratory's specific needs. All documents have a consistent look and feel to aid auditability.
Continuous Improvement: The package is updated in light of developments in regulations and enhancements to CDS software and by experience of using the package with other clients.
Requirements Traceability: A key feature of the documentation is both forward and backward traceability of functions between the user requirements specification and the test scripts used in the performance qualification.