503B · 21 CFR 210/211 · USP <797>/<800>
503B outsourcing facility software for cGMP batch records and quality evidence your team controls.
Outsourcing facilities are held to drug CGMP (21 CFR 210/211), not pharmacy rules. V5 keeps batch records, deviations, CAPA, complaints, stability studies and audit trails in one system. Your QA reviews the records and decides release, reports and submissions.
Electronic batch records
Deviations and CAPA
Complaints and recall support
Stability studies
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
Pharmacy tools rarely fit a facility held to drug CGMP.
Compounding software built for 503A pharmacies has no cGMP-style batch record
Environmental monitoring results sit on paper, away from the batches made in that period
Six-monthly product report data is rebuilt from spreadsheets each cycle
Tracing a complaint or adverse event back to the batch and its customers is slow
Stability data and beyond-use dating decisions are hard to find when asked
Records a 503B team can review in one place.
Electronic batch records
Step-by-step batch records against approved master instructions, signed and audit-trailed, for your QA to review.
Deviations and CAPA
Record deviations against the batch, investigate and track CAPA to closure; your QA approves.
Complaints and recall support
Complaint intake and investigation linked to the batch and the customers it shipped to. Your team decides on reporting and recall.
Stability studies
Manage stability schedules and results in the lab workspace, so the data behind your beyond-use dating is easy to find. Your QA sets the dating.
Environmental and lab results
Record monitoring and lab results with trend review, alongside the period's batches. Confirm your exact USP <797> monitoring set-up during evaluation.
Audit trail and e-signatures
Attributable, time-stamped records with an audit trail and electronic signatures, supporting your data-integrity approach.
What to check in a 503B evaluation.
- Walk one batch from master instruction to signed record and QA review
- Link a deviation to the batch, open a CAPA and follow it to closure
- Trace a complaint to the batch and the customers who received it
- Find the stability data behind a beyond-use date
The rules a 503B works under.
21 CFR 210 / 211 cGMP
Outsourcing facilities' drugs are not exempt from CGMP requirements; FDA inspects them on a risk-based schedule.
USP <797> / <800>
Sterile compounding and hazardous-drug handling standards — engineering controls, monitoring and gowning.
FD&C Act section 503B
Registration, six-monthly product reporting and adverse-event reporting to FDA, decided and submitted by the facility.
503B software, answered.
Isn't a 503B basically a pharmacy?
Not for FDA purposes. A facility elects to register as an outsourcing facility under section 503B; its drugs can qualify for exemptions from FDA approval requirements but not from CGMP requirements, and FDA inspects outsourcing facilities on a risk-based schedule. Software built for 503A pharmacy compounding usually isn't designed around 21 CFR 210/211 records.
Does V5 cover both sterile and non-sterile compounding?
V5's batch records, quality and lab tools apply to both. Sterile work needs its own monitoring and contamination controls, so confirm how those are set up for your facility during evaluation.
Can V5 produce our six-monthly product report?
V5 holds the batch data the report draws on, such as product, strength, dosage form and quantity.
How does V5 handle beyond-use dating (BUD)?
Stability studies and results are managed in the lab workspace so the evidence is easy to find. Your QA sets beyond-use dates and decides what happens to expiring stock.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Walk a 503B batch from record to QA review.
Free trial for evaluation. IQ/OQ and validation support are available with Enterprise.