Moving from paper to electronic batch records is often described as "going digital." For the people who run the batch and the people who review it, the change is more specific than that. The same approved master record is used, but some checks move from a person's attention to the system, and the review works differently.
This article walks through what changes for production and QA at a small or mid-size plant, and what stays exactly as it is.
What stays the same
Your approved batch manufacturing and packing records remain the basis of everything. With Atto Pharma eBMR, the site's own approved Word or PDF BMR or BPR is converted into screens. Each revision of the source document and its screens is kept and never changed. A new revision needs a reason, for example the change-control number. A batch stays on the revision it was made with.
The roles also stay familiar. The QA Head creates and issues the batch. People record on the operations they are cleared for, checkers verify, QA reviews each section, and the QA Head releases the batch.
What changes for production
On paper, the operator is trusted to follow the page and to notice a missing check or an out-of-limit value. On screen, the system enforces more of this:
- Steps run in order. A lot step opens only when the step before it is done and checked.
- Limits are checked as values are entered. An out-of-limit value is flagged at the field and needs a deviation number before its section can be signed off.
- The checker is a different person. The same person cannot do and check a step.
- You see only what you are cleared for. Screens outside your cleared operations are hidden and refused.
- Dispensing has pre-checks. Temperature, humidity and pressure-difference checks, area clearance, a certified operator, an approved and clean booth, and equipment and material lots fit for use all come first.
- Equipment status blocks use. Unqualified equipment, equipment past calibration or PM due, or equipment with a missing daily check cannot be used.
Mistakes are handled differently too. Nothing can be deleted. A wrong entry is fixed by a correction with a reason, and the original value stays visible in the audit trail.
One practical point: weights and readings are still typed in by the operator. There is no balance or instrument interface at present, so the entries are checked against the BMR's limits but not captured automatically.
What changes for QA
On paper, QA often meets the batch for the first time at the end, as a stack of pages. In an electronic record, QA is involved throughout:
- Only the QA Head issues and releases the batch. Nothing can be recorded before issue or after release.
- QA or IPQA reviews each section, and once QA has signed a section's review, nothing in it can be changed.
- Every exception appears in one list, so QA does not need to hunt through pages for flagged values.
- The complete batch record can be produced as a PDF at any time, with every value, limit, signer, time, exception, correction, review and release.
Review by exception: what it can mean in practice
Many QA teams want to spend review time on what is unusual, not on re-reading every routine entry. An electronic record helps with this because the exceptions are already collected. Out-of-limit values are flagged where they happen, each needs a deviation number before sign-off, and QA sees them together in a single list.
Two cautions apply. First, QA still reviews each section and signs that review. The software gives the reviewer a better starting point, but it does not replace the review. Second, how far your site relies on exceptions is a decision for your own procedures. Write it into your SOPs and test it during validation. The deviation itself is also handled in your quality system. Deviations, CAPA and change control are recorded in the eBMR by reference (their numbers), and their workflows stay in your own quality management system.
21 CFR Part 11: what the software supports
A computerized system is not "Part 11 compliant" by itself. Compliance comes from the system's controls together with your procedures and validation. Here is what the software contributes on the electronic-record and signature side:
- Signatures. Each signature stores the signer's name, its meaning (such as Done by, Checked by, Approved and released by QA) and the server's date and time. It cannot be changed, removed or copied to another record.
- Password at each signature. In QA and production, every signature needs the signer's password at that moment, checked by the database. Five wrong passwords in 15 minutes lock signing for 15 minutes.
- Audit trail. It is computer-generated and time-stamped by the server. Each change adds an entry in the editor's own name, earlier values are never overwritten, and a correction needs a reason.
- Server time. Entry and signature times come from the server clock, not the device, and record dates cannot be in the future (expiry, retest and due dates excepted).
- Access. Accounts use the company's own work email domain, are approved by the company's administrator, and sign out automatically after 15 minutes of inactivity. Two-step sign-in is optional.
- Record protection. Records cannot be deleted. Every saved version is kept in an append-only history chained by SHA-256, so a change made outside the application is detected.
The supplier also provides validation support: OQ and PQ modules for each product version, and an installation check for each release. The software is a configured product (GAMP 5 Category 4), delivered as software as a service. Your part is still the user requirements, risk assessment, validation plan and report, IQ/OQ/PQ execution, SOPs, training, periodic review and the decision to release the system for GMP use. A site also moves to a new release only when its own QA accepts it.
Practical takeaways
- Start from your approved BMR. Choose one product and see how its screens compare to the paper record, section by section.
- Decide your exception rules before go-live. Write down what QA reviews in full, what it reviews by exception, and how deviation numbers are raised.
- Plan training for both groups. Operators need to know the new checks, and reviewers need to know the exception list and section lock.
- Keep your boundaries clear. Balance readings are manual, and deviation, CAPA and change workflows stay in your own system.
- Plan validation early. Use the OQ and PQ modules, and put your own validation report and SOPs in place.
Try it in a 14-day pilot
If you want to see how this works with your own record, Atto Pharma eBMR and Atto eLogbooks can be tried in a free 14-day pilot. During a pilot, an evaluator may check their own work, and such entries are marked TEST. This makes it easy to walk through a batch alone before involving the wider team. Use the pilot to judge the screens, the checks and the review flow against your own procedures.
Originally published on siddhi.today.
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