Robust and Reliable Spreadsheets for Regulated Facilities
Transform your critical spreadsheets from a liability to a business advantage!
Transform your critical spreadsheets from a liability to a business advantage!
Better data integrity. Fewer quality and compliance issues. More efficient data management. Smoother validation projects.
You spend a fortune in time and money on validated, compliant software that are designed and developed by experts...
You spend a fortune in time and money on validated, compliant software that are designed and developed by experts...
...so why are you ok with trusting your critical data to that error-prone, deviation-causing spreadsheet built by Bob from Marketting?
...so why are you ok with trusting your critical data to that error-prone, deviation-causing spreadsheet built by
Bob from Marketting
?
Do any of these sound familiar to you?
"The
paper printout
is the regulated record!"
"But we checked 100% of the formulas back in 2017 as part of our validation..."
"Spreadsheets take too much time to validate."
"Oh, that's the old copy - a newer version was emailed out last week!"
"It's impossible to build and validate a spreadsheet for GxP use."
"QA checks all of our results before they get released!"
Here's the reality: Like any other software, spreadsheets used in a regulated or critical capacity need to be designed, developed, validated, and used in a way that maintains data integrity, quality and compliance.
Wouldn't it be great to have spreadsheets that are as robust as your other validated software?
Spreadsheets that...
are intentionally designed to meet your compliance
and
business requirements
don't take months to test and validate
don't require hand-checking every result
make QA, auditors and inspectors happy rather than causing
more
compliance issues?
I'm Brendan Hyland,
Spreadsheet Data Integrity Guru
.
I offer services and products specifically tailored to help regulated facilities like yours build robust, high quality spreadsheets that emphasize data integrity, compliance, and are easy to test and validate.
For example:
Assessments
of existing spreadsheets to help identify compliance and data integrity gaps and troubleshoot problems.
Evaluate Requirements, Design Considerations or Validation Planning
for new spreadsheets.
Design & Build Services
for regulated spreadsheets.
Spreadsheet Management System Assessments
to ensure you have the appropriate systems and SOPs in place to control and maintain the compliance, quality and integrity of regulated spreadsheets and data.
Training & Coaching
to help you build a team that's prepared for the challenges ahead.
We'll discuss your needs and how I can help. If I am confident that I can help you meet or exceed your goals, I'll put together a fixed price offer with a 100% satisfaction guarantee.
Here are some products and services I offer specifically to help your team with spreadsheets. Please feel free to
email me
or book a free call if you have questions about which might be the best fit for you.
Spreadsheet Consult and Troubleshooting Session - CDN$325
Spreadsheet Consult and Troubleshooting Session
-
CDN$325
Are you trying to solve a specific problem regarding a regulated or critical spreadsheet, its testing or validation?
Is it something that you feel doesn't justify hiring someone on a project basis, but still need some expert guidance?
Book a 1-on-1 consult now. I'll review the spreadsheet and any other details you provide, and you'll get an hour to ask me any questions you have about specifying, designing, developing, testing and validating that spreadsheet. We can even share screens and I'll show you tips, best practices, and actionable advice that apply specifically to your problem.
Don't waste another day spinning your wheels. Get Answers - Get Unstuck - Take Action
Don't waste another day spinning your wheels. Get Answers - Get Unstuck - Take Action
The Pre-Validation Spreadsheet Audit - CDN$2,995
The Pre-Validation Spreadsheet Audit
-
CDN$2,995
This service evaluates one existing spreadsheet, producing a high-value report full of actionable advice to ensure data integrity, traceability, and ease of testing and validation.
You'll get answers to questions like:
How much risk does this spreadsheet pose to operations, data integrity or compliance?
Are there changes I can make or best practices to protect my valuable data?
Do I need to validate it?
How detailed should validation testing go?
What can I change that could make validation easier?
This should be considered the first step before using a spreadsheet in a regulated environment or anywhere you need a high level of data assurance. It will save you time and effort in the long run and help you reduce the risks to any data being handled by the spreadsheet.
We start with a meeting to go through the spreadsheet and establish your goals, as well as to identify any process, compliance and validation requirements you have.
Once you have sent me a copy of the spreadsheet itself I'll go through it with a fine-toothed comb, looking for best practices, risks, validation complexity and compliance pitfalls.
The written report provides:
An analysis of the risk that the spreadsheet in its current form poses with respect to your stated requirements and best practices;
Actionable, step-by-step advice for making improvements to the spreadsheet to increase data quality, reduce operator errors and simplify validation; and
A recommendation for the level of testing and/or formal validation that should be performed on the spreadsheet before releasing it for operation.
Reduce the risks posed by your mission-critical spreadsheets while saving time and money on your validation efforts.
Reduce the risks posed by your mission-critical spreadsheets while saving time and money on your validation efforts.
Validation Coaching Program - Contact Me
Validation Coaching Program
-
Contact Me
This 3-month coaching program starts with training and ends with the validation deliverables required to release one existing spreadsheet. A simple, standalone COTS computerized system may be substituted.
In addition to having a validated spreadsheet, at the end of this 3 month program your team will be able to:
Identify when and how spreadsheets should be validated
Write requirement specifications that make it easy to develop and test your spreadsheet
Develop spreadsheets that are easy to validate
Write and execute a validation plan and test scripts that cover what matters
Each week we'll meet on Zoom and tackle a different part of the spreadsheet design, development and validation cycle. Includes:
•
A Spreadsheet Validation Training session.
•
A Pre-Validation Audit of the chosen spreadsheet, walked-through with the team.
•
Guided development and reviews of the spreadsheet URS document, validation plan, test scripts and the validation report.
Note: This coaching program assumes a 3-month engagement and requires a commitment from the validation team to get the components completed on time. Of course I understand that schedules and priorities can change, and additional support and validation document review can be added as necessary at a monthly rate.
Other Support
Other Support
I can offer a range of design, development and validation support services for spreadsheets, data analysis tools or computerized systems, including:
Custom Spreadsheet Development
Risk Assessments and Gap Analyses
SOP and Template Reviews
Roadmaps and Strategy Development
Validation Deliverable Reviews
Schedule a free call to discuss, and if I am confident I can help you I'll put together a fixed price for the project and a 100% satisfaction guarantee.
What do people say about working with Brendan?
What do people say about working with Brendan?
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
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.
Brendan helped us manage a complex, multidisciplined pharma project. He 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
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
Questions and Answers
Questions and Answers
What's wrong with spreadsheets?
What's wrong with spreadsheets?
Spreadsheets are great! They are familiar, flexible, and easy to use. The instant visual feedback you get when playing with data makes them the go-to choice for developing quick data applications without having to involve IT or hire programmers!
However, all those features of Excel or Sheets that let you easily manipulate and visualize your date make testing,
validating, and maintaining the long-term stability of the code base a challenge.
This is especially true if you're trying to re-use the functionality to analyse multiple or evolving datasets.
Creating spreadsheets for regulated, or critical use cases that are high quality, assure data integrity over time, and are easy to test and validate, is by no means impossible but requires expertise and discipline.
That's where I come in.
But our spreadsheets are 100% validated! I trust them implicitly!
But our spreadsheets are 100% validated! I trust them implicitly!
That's great! If you're not having any of the problems I described above, then you probably don't need my services.
But in my experience I haven't yet seen a spreadsheet being used in a regulated environment that met the level of data integrity and traceability that is expected by modern best practices and regulators everywhere.
Don't believe me? Just show it to an experienced auditor and ask them if they see any ALCOA+ violations!
What are your hourly rates?
What are your hourly rates?
I offer fixed price services and projects with guaranteed outcomes. That means that there are no hourly rates, and more importantly no hourly overages! If I take on the project then
I'll take on the risk
that it takes longer than expected. You pay the price that we agree upon, no more.
The only exception is for coaching programs, which are designed around a fixed time period and dependent on the project team completing milestones within that period. Of course I understand that schedules and priorities can change, and in these cases additional support can be requested as necessary at a monthly rate.
What happens after I apply?
What happens after I apply?
In most cases we'll schedule a 1-on-1 meeting by Zoom so that we can introduce ourselves, discuss your business, any goals you have, and availability. If I'm confident that I can help you, I'll provide a guaranteed fixed price for the service.
Once your payment is processed, I will work with your team to gather any information required, schedule any meetings or travel, and get started on document review and the project plan.
When is payment due?
When is payment due?
The troubleshooting sessions and spreadsheet audits require full payment up front.
For any of the other project-based services you will have two options for payment:
1.
Pay in full, up front, and you'll
get 10% off
2.
Pay 50% up front and the remainder is due in 30 days.
In all cases, a first payment is required before I will schedule any travel or project work.
Is GST/HST included in prices?
Is GST/HST included in prices?
No, GST/HST is not included and will be calculated at the time of checkout if and as applicable.
You said 100% Satisfaction guarantee. What does that mean?
You said 100% Satisfaction guarantee. What does that mean?
The 100% satisfaction guarantee means that if you aren't satisfied with the service that I provide, I will do what I can to make it right. What this means for each project or service will be laid out in clear, concrete terms.
What if we need something different?
What if we need something different?
Contact me
and we'll talk. If I think I can help you, I'll provide you with a fixed price for a guaranteed outcome.
Why work with Brendan?
Why work with Brendan?
I'm a
GLP systems strategist
with engineering degrees, RQAP-GLP and software design experience. I have been designing, building, fixing and automating systems for GLP, GMP and GPP facilities for 20 years.
In that time I've helped build several facility's quality systems from the ground up, run QA departments, performed and hosted many compliance inspections and audits, validated computerized systems and even built Software as a Service offerings.
I've also helped companies hammer some very square off-the-shelf systems into the very round holes of their operations.
Stop relying on software feature pages and sales people to tell you what you need!
Stop relying on software feature pages and sales people to tell you what you need!
What were the most common reason for problems I've seen over the years? Not taking the time to properly frame and communicate a full scope of user, compliance and technical requirements. So often, the only real design effort that was put into the system was to make sure basic regulatory / QMS compliance boxes were checked!
I believe that front-loading the effort into an intentional design of regulated processes, all stakeholders, 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.
When you hire me on, I make sure our priorities align.
When you hire me on, I make sure our priorities align.
I guarantee the outcomes that we agree on, meaning I need to become a strategic partner who is laser-focussed on helping you meet
your
goals. So unlike large consulting firms, you get
my expertise
focused on
your company's needs
.
I don't profit by needlessly increasing project complexity, or by taking on endless paperwork tasks that will be pushed to junior team members. My projects have a fixed price and a definite end based on a guaranteed outcome that we agree on. No hourly overages, no never-ending projects that generate more paper than results.
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!