Founded in 1993, McDowall Consulting has Bob McDowall as the Principal. The company is responsible for the delivery of consultancy services, either by Bob directly or through our experienced Associates to a client’s specific requirements.
Some of the services provided by McDowall Consulting for the pharmaceutical, biotechnology, medical device and contract research organisations (CROs) are:
If topics are not covered here please contact us to see if we have expertise that we can offer.
Consultancy services for process re-engineering and/or redesign (also known as workflow analysis) in all areas of the pharmaceutical industry from research, development to manufacturing. Process redesign can be used either as either a diagnostic tool or as an aid to writing System Requirements Specifications (SRS). Most processes have evolved over time and have not been designed for effective use of time, equipment or resources. Mapping your process can be a revelation and a surprise! If you want to make an investment in equipment, computerised system or to improve overall effectiveness of a functional unit in an organisation, then this is an essential first stage.
Alternatively process redesign can be used as a way to remove non value added activities and release resources for use on added value tasks within an organisation.
The first line of defence that a corporation should have is a corporate computerised system validation policy. This is the interpretation of the regulations for an organisation and balances the costs of compliance and the amount of regulatory risk that the company is willing to accept. We advise, facilitate or review corporate validation policies or can supply a template that speeds up the process of policy development.
Interpretation of the 21 CFR 11 (Electronic Records; Electronic Signatures final rule) requirements is important defence for any organisation. We can supply a template document or advise, facilitate or review existing corporate 21 CFR 11 policies.
Training courses for awareness of the requirements of electronic records and electronic signatures final rule can be the start of the compliant assessment. In-house training courses are available for training of assessment teams that run over 2-5 days and can include assessments of a client’s systems to give a start on the assessment process. Remediation of non-compliances can be developed as the course progresses. Training of Quality Assurance staff to review and challenge compliance assessments.
Written for a site, facility or department using the framework outlined in European Union GMP Annex 11 this document lists the computerised systems and equipment covered by the plan. This document classifies the system risk and prioritises the validation schedule for all items in the plan. We can prepare or review these documents.
Training courses for a number of topics are available – we suggest that you look at the training courses section of our consultancy services. These can be customised for a specific client.
For more effective learning about specialised topics, we offer customised extended learning programmes to ensure effective technology transfer. This are developed on a case-by-case basis, so please contact us for more detailed discussions on your needs.
We offer a service for advising or reviewing computerised systems in regulated environments that are either being developed or are operational; we can confirm that development follows current best practices or that the operation of the system is compliant or not.
Increasing focus is being placed on Information Technology departments within regulatory industries especially with the requirements outlined in 21 CFR 11; therefore regulatory awareness and compliance must be implemented urgently. We offer training and consultancy for regulatory awareness and planning for compliance as well as audits to find if there are any problems within IT. Qualification of local area or wide area networks (LAN and WAN) and maintenance of the qualified status is important and we can offer services and standard operating procedures for data centres, networks and infrastructure.
Audits are a rapid and cost-effective way to find out the compliance status of computerised systems that operate in regulated industries. Using a predefined checklist based on interpretation of regulations and our experience we can audit any system either before a regulatory inspection or a system has gone live. This diagnostic tool can highlight ways to bring a system into compliance. These are friendly audits that can be used to train and educate system owners in validated environments.
Training internal auditors to inspect computerised systems can be provided as a specific training course or an extended learning programme.
Bob McDowall is a leading world expert in LIMS; he edited the first book on LIMS in 1987 and was given the 1997 LIMS Award for advancing the subject. Our consultancy services can provide expert input into a LIMS project from concept, defining the process and user requirements, system selection through to the validation of the configured system.
We have over 30 years experience with chromatography data systems and we offer consultancy services for the definition, selection, implementation and validation of a CDS. Using our QualifyPLUS® validation package the time scale of the whole project can be reduced substantially (see R.D.McDowall Ltd for further details).
Use of electronic signatures in voluntary under 21 CFR 11 regulations, however by implementing electronic signatures there are substantial business benefits that can be obtained by going electronic. We have expertise in the implementation of electronic signatures as well as being able to provide generic procedures and policies required under 21 CFR 11 for customisation to a specific situation.
Understanding the process, evaluating the technology options, facilitating and prioritising improvement ideas, assessing the impact on the organisation of the strategy and developing the strategy.
Based on Bob’s extensive writing and presentation skills; we offer are extended learning programmes for both effective scientific writing and presentation skills for scientists and medical staff.