Software Company in Raleigh: A Traceability Matrix for Life Science Systems in the Triangle

Updated November 2026 · Written and maintained by the Progression Agency strategy team

The requirement fits on one line: the system shall record who changed a value, when, and what it was before. Proving that line to a quality auditor takes a chain of documents. A software company in Raleigh building for Triangle life science firms has to think in that chain from the first sprint. This page builds a traceability matrix row by row, from requirement to test to evidence, with 21 CFR Part 11 as the reference. It is for quality, IT and product leads at sponsors, device makers and contract manufacturers. Progression is based in New York and serves Raleigh firms remotely, with on-site sessions on request.

One requirement, one line

Begin with a single sentence from a requirements document. The card shows what it looks like with the pieces an auditor will ask for sitting behind it.

Most of the work is not in writing that sentence. It is in making sure a second person, months later, can find the test that proved it and the saved result of running that test.

What a software company in Raleigh must know before the first sprint

A software company in Raleigh that builds for life science firms in the Triangle works for people who will be audited. The Research Triangle Regional Partnership says there are over 675 life science companies in the region and 24,150 people employed in life sciences there, and it notes that some firms manufacture drug therapies at scale.

Part 11 of Title 21 covers electronic records and signatures. Whether a given record falls under it depends on which FDA rule requires the record, so the first question to a quality lead is which rule applies. This page uses 21 CFR 11.10 as its reference because it is the section that controls closed systems, and it never says a system is compliant.

Who decides what applies?

Your quality lead and, where needed, your counsel. A software company can build to a stated requirement, but only the regulated firm decides which requirements its records need.

The traceability matrix

The matrix puts each requirement in a row with its reference, its test, its evidence and its owner. The six rows below come from 11.10 and show the shape. Your own matrix will have many more.

Row by row: 11.10(e)

Three of the six rows come from one paragraph. It asks for secure, computer-generated, time-stamped audit trails that independently record the date and time of operator entries and actions that create, modify or delete electronic records. Record changes shall not obscure previously recorded information, and the trail is retained at least as long as the records and available for agency review and copying.

Rows for access and authority

Paragraphs (d) and (g) turn into rows about who gets in and who can do what once inside. The test for each is simple to state: try the action as someone who should not be able to, and save the result.

• Write each role once, with the actions it may take.
• Test the actions a role should not have, not only the ones it should.
• Save screenshots of the refusals.
• Record when a role changes and who approved the change.

What the matrix costs to carry

A software company in Raleigh, NC pricing a regulated build adds real time for validation documents, and that time is better planned than discovered. Writing tests, running them, saving evidence and updating the matrix after each change takes effort on top of the code itself.

Bands for regulated systems

These are the market bands for the underlying software. The documents add to them, and they are not a separate band.

Hosting, licenses and security testing come on top. Progression quotes after a written scope that names the documents it includes.

Costs that sit with your quality team

Reviewing and approving the documents is your team’s work, and so is the decision about what level of testing each row needs. Plan their hours next to the build hours.

Risk based, for devices

FDA’s guidance Computer Software Assurance for Production and Quality Management System Software, final in February 2026, gives recommendations for computers and automated data processing systems used as part of medical device production or the quality management system. It describes a risk-based approach to establish confidence in the automation used.

It is a device guidance. For drug and biologic work, ask your quality lead which expectations apply. It is also not an interpretation of Part 11. What it offers a software team is a way to think about where more rigor belongs and where less will do, which makes the matrix shorter in the low risk rows.

Raleigh software development after validation

Software development in Raleigh for a validated system does not end at release. Every later change has to answer one question: which rows of the matrix does it touch?

• Each release note lists the matrix rows it affects.
• A change that touches a row triggers a retest of that row.
• A change that touches no row is noted as such, with the reason.
• A hotfix gets the same note, written afterward if it must be.
• The note names who approved the release and when.
• The matrix gets a new version number with every release.

What triggers a retest?

Any change to code, configuration or a connected system that could alter how a row’s requirement is met. When in doubt, retest the row.

Custom software development in North Carolina or a validated product

Custom software development in North Carolina is one answer, and a validated product is another. A product that arrives with its own validation package can save time, though your team still owns how it is configured and used. See our page on custom software versus off the shelf for the broader choice.

Custom software development in Raleigh makes sense for the parts nobody sells: the workflow that matches your process, the connection between two systems, the report your auditors ask for. A layer around a validated product often beats replacing it. For health sector systems more broadly, see our healthcare software development page.

Software companies in Raleigh and a one hour audit rehearsal

Software companies in Raleigh are easy to list and hard to compare. One test cuts through: pick a row from the matrix and ask the firm to produce the evidence in an hour.

1. Choose one row, such as audit trail entries.
2. Ask for the requirement, the test and the executed result.
3. Ask who signed the result and when.
4. Ask what changed in the system since, and what was retested.
5. Watch how long it takes, and what the firm says it cannot produce.
6. Repeat with a second row chosen by someone else on your team.

Software companies in Raleigh, NC that build for regulated customers will have done this before. If software development in Raleigh, NC is new to a firm, the rehearsal shows it quickly. For advertising work in the same market, see our advertising agency in Raleigh page.

How deep should each row be tested?

Depth follows risk. A row about who can alter a quality record deserves a full scripted test with refusals. A row about the color of a button does not. The table gives a simple way to sort rows, and your quality lead sets the final levels.

Can one test cover two rows?

Yes, if the script names both rows and the evidence shows each result separately. A single test that proves two sentences at once is fine as long as the matrix points to it twice.

What does a good evidence file look like?

A name, a date, the steps as run, what happened, and a signature. Anyone should be able to open it cold and see what was proved.

Who writes which document?

A validated build has more authors than a normal one. The table shows who typically writes which document and who approves it, and your quality procedures set the final assignment.

• Agree the template for each document before the first sprint.
• Give every document a version and a date.
• Keep drafts out of the folder that auditors open.
• Name the person who keeps the index page current.
• Store signed evidence where it cannot be edited later.
• Review the folder at the end of every release.

What the auditor sees at the end

At the end of a project, an auditor should be able to open a short set of documents and follow any requirement from sentence to saved result.

Ask your quality lead which of these your own auditors expect, and in what format. For biotech and life science firms that also need a web presence, see our biotech website design page.

Related services and guides

Pages that sit beside this one:

• Software development company
• Healthcare software development
• Software consulting services
• Custom software versus off the shelf
• Biotech website design
• Advertising agency in Raleigh

Frequently asked questions