Products and Services
I'm Brendan Hyland. I help regulated facilities transform their Quality Documents, Spreadsheets, 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 an SOP, 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 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 service packages and products 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.
The SOP Diagnostic Evaluation - CDN$995
The SOP Diagnostic Evaluation
-
CDN$995
A systematic and in-depth review of one SOP and its forms providing you with a customized, high-value report full of actionable advice to:
Improve the quality of your procedures and forms, allowing your reviewers to focus on technical content and regulatory compliance;
Make your process easier to follow and document correctly, reducing the number of deviations and compliance issues; and
Increase the efficiency of the underlying process, saving you time and money every time the SOP is used.
Transform an SOP from a slow, deviation-prone regulatory burden to an optimized business process.
Transform an SOP from a slow, deviation-prone regulatory burden to an optimized business process.
Book a 1-on-1 Consult with Brendan - CDN$325
Book a 1-on-1 Consult with Brendan
-
CDN$325
Have a pressing question or a specific quality or validation problem? Need help solving a broken quality process quickly? What if you could talk to an expert who can help you get moving now?
Book a 1-on-1 consult now. I'll review the details and you'll get an hour to ask all the questions you want of an expert who's been there.
Quality problems can be expensive. Don't waste another day spinning your wheels.
Quality problems can be expensive. Don't waste another day spinning your wheels.
Services for Developing and Validating Spreadsheets - from CDN$325
Services for Developing and Validating Spreadsheets
-
from CDN$325
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
In addition to the service packages listed here, 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. For an example of what coaching programs look like, see the
spreadsheets product page
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
For examples of how these are usually structured, you can look through some of my fixed-price offerings for
spreadsheets
, or contact me to discuss other systems.
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.
Still have questions?
Still have questions?
What others say about my work
What others say about my work
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
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, Cannabis Extraction Facility
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
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.
I would definitely recommend Brendan's services - he is a jewel to work with!
Debi Garvin
, MS, RQAP-GLP, Pacific Rim Consulting and Training
About Brendan
About Brendan
I'm a multidisciplinary computer geek with an engineering degree, RQAP, 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, and even spent a few years as the
QAP
of a cannabis extraction facility responsible for safely releasing product. 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 Daily HaiQu newsletter and explore how to make incremental improvements that design quality and efficiency into your systems.