Document review support
Summaries and checklists drawn from protocols, reports and specs, with source links.
Custom software for life sciences teams.
Quality, regulatory and operations teams spend their days moving information between documents, spreadsheets and validated systems. We build tools for the work around those systems, designed with your quality team from the start.
Common problems
Where the time usually goes.
Today
- Documents get reviewed line by line
- Supplier qualification lives in email
- Reports pull from several systems
With the system
- AI pulls out the details reviewers check, with links to the source, so experts confirm instead of retype.
- Questionnaires, certificates and audits tracked per supplier, with renewals on time.
- Quality and operations numbers come together without a monthly spreadsheet project.
What we can build
Examples for your kind of organization.
Every project starts by looking at how your team actually works, so yours may look different.
Supplier qualification
Collect, check and renew supplier documents in one place.
Deviation and CAPA follow-through
Owners, deadlines and evidence tracked so nothing stalls.
Training records
Who is trained on what, with reminders before it lapses.
Regulatory submission support
Assemble and check the pieces of a submission from your approved content.
Cross-system reporting
One view across quality, manufacturing and lab systems.
Handled with care
What we watch for.
Electronic records and signatures used for FDA-regulated work fall under 21 CFR Part 11, and many systems need validation under your quality system. We design with your quality team, document what the software does, and start where validation isn't required when that makes sense. We don't claim validated or certified systems we haven't delivered.
Related problems
Common places to start.
Documents piling up
Contracts, forms, invoices, reports. The information your business needs is locked inside PDFs, and someone has to read each one.
Read moreApprovals stuck in email
The request went out on Monday. By Friday, nobody knows who has it. The person who needs to approve it never saw it, or forgot.
Read moreReports built by hand
Every month, someone exports from four systems, pastes it all into a spreadsheet and fixes what looks wrong. By the time it's ready, the numbers are old.
Read more
FAQ
Common questions.
Can AI make quality decisions?
No. It organizes, drafts and checks. Qualified people make and sign the decisions.
Do you replace our QMS or LIMS?
Usually not. We connect to them and handle the work they don't cover.
Partner with Inkwell
Tell us where the time goes.
A few sentences is plenty. We'll tell you honestly whether custom software makes sense.