Products and Services
I'm Brendan Hyland. I help regulated facilities transform their Spreadsheets, Software, Processes and Systems from a time-consuming regulatory burden to a competitive advantage.
If you are a manager in a regulated industry who is:
Facing a specific problem with a spreadsheet, computerized system, recordkeeping or quality process that could benefit from an experienced troubleshooter;
Evaluating a new data analysis tool or computerized system;
Using spreadsheets anywhere that requires a high level of data integrity, traceability or validation; or
Looking to improve your team's skills in Spreadsheet Development, Good Documentation Practices, Data Integrity or Validation;
...then you're in the right place. I offer a wide range of consulting options and services for folks just like you.
I can help you:
Identify
opportunities to front-load effort in your processes to increase quality and reduce day-to-day running costs;
Uncover
the root causes of deviations, quality problems and bottlenecks;
Design
processes, SOPs, forms and spreadsheets that improve data integrity, reduce the compliance and validation burden and increase operating performance;
Plan
high level quality, validation and process improvement projects that do more for your business than wait for the next audit; and
Coach
your team through these projects, helping to ensure success at every stage.
Want to discuss a project or a specific problem that you're having?
I've listed some specific areas that might fit many of your project needs. Please feel free to
email me
or book a free call if you have questions about which might be the best fit for you.
Services for Developing and Validating Spreadsheets
Services for Developing and Validating Spreadsheets
Practical advice and services to help you design, develop and validate spreadsheets for regulated facilities and in other situations where you need a high level of data integrity and quality.
Services for Improving Quality Systems
Services for Improving Quality Systems
I can offer a full range of services to help you troubleshoot, design, plan and build efficient and compliant quality processes, including:
Gap Analyses and Process Audits
Roadmaps, Project Planning and Designs
Team Coaching on a monthly basis.
All projects start with a meeting to establish your goals and scope out the project, as well as to identify any process, compliance and validation requirements you have.
Validation Support
Validation Support
I can offer a full range of validation support services for spreadsheets, data analysis tools or computerized systems, including:
Risk Assessments and Gap Analyses
Validation SOP and Template Reviews
Validation Document Reviews and Audits
Roadmaps and Strategy Development
Team Coaching through Validation Projects
If I am confident that I can help you meet or exceed your goals, I'll put together a fixed price for the project and a 100% satisfaction guarantee.
Sound Good? Let's Talk!
In order to offer a high quality of service with guaranteed results I need to limit the number of new clients I take on. My schedule fills up quickly, book that call now so you won't be disappointed!
What others say about my work
What others say about my work
We were trying to develop a Part 11 compliant system so that any digital photo could not be deleted or altered. Brendan offered several detailed solutions to the problem and got us going in the right direction. I would definitely recommend Brendan's services - he is a jewel to work with!
Debi Garvin
, MS, RQAP-GLP, Pacific Rim Consulting and Training
Your investigation into anomalous analytical results was excellent. Thanks to your diligence, you determined that the incorrect cap was used for the lyophilization ampules, adversely affecting stability.
Solomon Schachner
, Director of Pharmaceutical Technology, UGM Engineering
Most of our staff had industrial experience but not in pharmaceutical or food manufacturing. Brendan set up a series of formal and hands-on training sessions for our staff in how to use the Quality Assurance system effectively to eliminate public health risks and to make a repeatable high quality product.
If you need someone to provide deeper insights into your QMS or to train staff, I would definitely recommend they hire Brendan. Overall, I was happy with the experience and would like to find opportunities to work together again.
Wayne Jackson
, P. Eng., Chief Operations Officer, Endless Sky Inc.
For many years, Brendan has been my go-to person when I've had questions about our computerized systems. I can always count on a thorough and clear explanation of the issue and my options. I'd definitely recommend his services.
Gordon Cowan
, P.Eng., President, UGM Engineering
Brendan was amazing at simplifying complicated forms and procedures which allowed our processes to be straightforward. If something goes wrong my first thought is "What would Brendan do?" as he always had a clear logical way to solve the problem while ensuring compliance with regulations.
Rheanne Dekeyser
, QAP
Brendan always seemed to be in right place and right time to connect people and their tasks. I do not hesitate to strongly recommend hiring Brendan, he would be extremely valuable asset to any team. His experience and personality are hard to compare with anybody that I'm aware of.
Dr. Felix Polyak
, Ph.D., Director of Chemical Development
We learnt so much from Brendan. He set up training sessions that paid very close attention to areas where we were lacking. This always proved to be highly effective.
Corey Fletcher
, Operations Manager
About Brendan
About Brendan
I'm a multidisciplinary computer geek with an engineering degree, RQAP-GLP, communication skills and lab experience. I have been designing, building, fixing and automating quality systems for GLP, GMP and GPP facilities for the better part of 20 years.
In that time I've run QA departments remotely, performed and hosted many compliance inspections and audits, validated computerized systems, built Software-as-a-Service and even spent a few years as the
QAP
of a facility responsible for safely releasing CBD products.
I've built quality systems from the ground up, and also helped companies hammer some very square off-the-shelf SOPs into the very round holes of their operations.
I've written, reviewed and fixed
hundreds
of quality systems components such as spreadsheets, SOPs, forms, specifications and validation plans. I've seen the good, the bad and the ugly, and personally felt the pain of being governed by badly designed SOPs, MBRs, forms and validation documents.
The most common reason for problems? The only real design effort that was put into these components was to make sure the regulatory / QMS compliance checkboxes were satisfied.
I consider it my mission to help regulated companies move beyond just compliance to improve data integrity, product quality and process efficiency
I believe that frontloading the effort into an intentional design of regulated processes will pay back multiples in your day-to-day operations. It's not always easy, but with the right tools and techniques it can be made simple.
Join me
on the HaiQu newsletter and explore how to make incremental improvements that design quality and efficiency into your systems.