A quality record is only worth something if you can trust it: who made it, when, what was measured and whether anything changed afterwards. Data integrity in manufacturing quality comes down to records that are attributable, legible, contemporaneous, original and accurate, known as ALCOA, plus a few principles that keep them complete and available for years. This guide turns those principles into controls a plant can run every shift. See them working on real records in a short data integrity demo.
Every Quality Record Attributable, Time-Stamped and Traceable
iFactory Data Integrity Controls put an audit trail on every record, apply e-signatures with meaning and capture timestamped voice entries at the point of work. Back-dated or edited data raises an alert to your quality lead, with the original value kept.
Nine Principles, and What Each Looks Like on the Floor
FDA's 2018 guidance defines ALCOA as data that is attributable, legible, contemporaneously recorded, original or a true copy, and accurate. The UK MHRA's 2018 guidance notes that the "+" adds complete, consistent, enduring and available, and that it changes nothing in what is expected. It simply spells it out. Talk through how each principle applies to your records with our quality support team.
Data Integrity Is Not Just a Pharma Topic
The strongest guidance comes from drug regulators, but the same ideas run through other sectors. FDA's food safety rule requires records made at the time of the activity, kept as originals or true copies, and accurate, indelible and legible. ISO 9001 asks for documented information protected from loss of integrity, and IATF 16949 sets retention for automotive records. Medical device makers meet FDA's QMSR, which since February 2026 incorporates ISO 13485. Walk through the rules that apply to your plant in a compliance mapping call.
Where to Look First: Criticality Against Risk
You can't fix every record at once. MHRA's guidance suggests ranking data two ways: how much it drives quality and release decisions, and how easily it could be changed or left out without anyone noticing. The heat map below places typical records as an illustration. Your own ranking will differ. Build your map with our support team.
Seven Part 11 Controls and Their Equivalents Elsewhere
Whatever system holds your quality records, these are the controls that make its data trustworthy. Pharma rules name them most clearly, and every other quality system has an equivalent. Check your current systems against this list in a systems review.
Know Which Records Changed, Who Changed Them and Why
iFactory keeps an audit trail on every record and watches for the patterns that matter: late entries, edits after sign-off and values with no reason. Your quality lead hears about them the same day, not at the next audit.
Six Patterns That Point to a Data Integrity Problem
Most data integrity problems aren't fraud. They come from pressure, habit and systems that make the wrong thing easy. The same patterns show up again and again in inspection findings, and each one leaves a trace a system can spot. Ask our support team which alerts suit your records.
Recording the Reading Where It Is Taken
The easiest record to make contemporaneous is one that never waits for a keyboard. A spoken entry at the station is attributed, time-stamped and confirmed back before it is saved. Decide and document whether the confirmed transcript or the audio is your original record, as MHRA defines it as the first capture of the data. Hear a voice entry in a live voice demo.
What a Useful Audit Trail Line Contains
Part 11 calls for secure, computer-generated, time-stamped audit trails in which changes never hide what was recorded before. FDA's 2018 guidance says audit trails belong to the records the quality unit reviews. A trail is only useful if a reviewer can read it in seconds. See sample trails from our support team.
A Self-Assessment You Can Tick Through Today
Work through this list for one line or one lab. Each unticked box is a gap worth an owner and a date. Get a version shaped to your sector in a self-assessment session.
Three Before-and-After Illustrations
These illustrations show common gaps and the controls that close them. They are not case studies. Share your own trouble spots with our quality support team.
Six Habits of Plants With Trustworthy Records
Good data governance is more culture than software. PIC/S PI 041-1 treats organisational behaviour as part of data integrity, and MHRA makes senior management accountable for it. These habits keep the controls working after the project ends. Plan a rollout with our quality specialists.
Data Integrity Controls Delivered on Your Own Server
iFactory delivers Data Integrity Controls as a turnkey system. A pre-configured NVIDIA AI server ships racked and ready, with audit trails, e-signatures, voice entry and alert rules installed, so quality records stay inside your plant. You rack it, plug in power and Ethernet, and the AI is live. Scope it for your site with our support team.
- Pre-configured NVIDIA AI server, racked and ready
- Audit trail on every quality record
- E-signatures with name, time and meaning
- Timestamped voice entry with confirm-back
- Alerts for back-dated and edited data
- Connectors to MES, LIMS, CMMS and QMS
- 24×7 remote monitoring of hardware and models
Data map agreed, record types ranked, server installed, user directory and systems connected.
Entry windows, signature meanings, voice terms and alert rules set and tested with your team.
First lines live, users trained, weekly audit trail review started with quality.
Integrity Built Into Every Record, Not Checked Afterwards
iFactory makes the right way to record data the easiest way, then watches for the exceptions. See it end to end in a platform walkthrough.
What Quality Leaders Ask About Data Integrity
Records You Can Defend in Any Audit
Put an audit trail on every quality record, capture readings by voice at the point of work and get alerts for back-dated or edited data. The system is delivered turnkey and goes live in 6 to 12 weeks.
