Robust and Reliable Spreadsheets for Regulated Facilities
Don't Let a Badly Designed Spreadsheet Burn Your Company!
Don't Let a Badly Designed Spreadsheet Burn Your Company!
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 a junior from marketing?
...so why are you ok with trusting your critical data to that error-prone, deviation-causing spreadsheet built by
a junior from marketing
?
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 require hand-checking every result
don't take months to test and validate
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, troubleshoot problems, and provide a way forward.
Evaluate Requirements, Design Considerations or Validation Planning
for new spreadsheets.
Design & Build Services
for regulated spreadsheets.
Spreadsheet Management Process Assessments
to ensure you have the appropriate systems and procedures 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.
Please feel free to
email me
or book a free call if you have any questions about which might be the best fit for you.
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 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 data 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 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
GxP 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, been on both ends of inspections and audits, validated computerized systems and even built Software-as-a-Service.
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 critical 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.
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!