Dietary supplements · Part 111
Specifications, identity testing, batch records, and quality control review. Read the Part 111 guide.
- Applies to
- 21 CFR Parts 111, 211, and 11
- Subject
- GMP quality work, records, and signatures
- Ovada’s role
- Does the work · qualified people sign
GxP compliance software
GxP compliance software that keeps GMP quality work controlled
Ovada runs regulated quality work inside defined, repeatable workflows. Every check is tied to the requirement behind it, every finding is traced to its evidence, and every decision stays with a qualified person.
Material disposition · RM-24-117Every action recorded
Release, reject, or hold this lot?
Microcrystalline cellulose · Lot RM-24-117 · Castellan Excipients
Ovada recommends release
All 19 parameters within specification. Microbial limits confirmed on the revised COA. The call is yours.
Evidence
- Certificate of analysis · rev 2Open ↗
- Approved specification · RM-SPEC-0142 v3Open ↗
- Supplier qualification · Castellan ExcipientsOpen ↗
- Correspondence · 4 messages, 2 checksOpen ↗
✓
Approved for releaseSigned by Dana Reyes, QA manager · Meaning: approve for release · 18 Sep 2026, 14:42 UTC
21 CFR Part 11Audit trail
- 16 Sep 09:02 · COA, spec v3 and supplier approval linked
- 09:03 · Gap: microbial limits missing from COA
- 16 Sep · Request sent to Castellan Excipients
- 17 Sep · Reply checked: same COA
- 17 Sep · Follow-up sent
- 18 Sep · Revised COA verified, within specification
- 18 Sep · Routed to Dana Reyes · responsibility matrix
- 18 Sep 14:42 · Part 11 e-signature · Dana Reyes · approve for release
Requirement by requirement
What GxP compliance software has to do
GxP covers the good practice rules for regulated products. For manufacturers, that means GMP: 21 CFR Part 111 for dietary supplements and 21 CFR Part 211 for finished pharmaceuticals. Software that supports GMP work has to hold up to the same scrutiny as the work itself.
| Section | Requires | How Ovada meets it | Evidence you get |
|---|---|---|---|
| 211.22 · 111.105 | A quality unit with authority to approve or reject | Routes every regulated decision to the quality unit with its evidence attached | Decision history: who reviewed, decided, and signed |
| 211.100 · 111.103 | Written procedures, followed the same way every time | Runs each workflow from your approved procedure, with defined checks and review gates | The procedure version applied to each run |
| 211.192 · 111.113 | Investigation and review before disposition | Gathers the records, reconstructs events, and drafts the investigation | Findings traced to their source records |
| 211.180 · 111.605 | Records that are complete, available, and unaltered | Keeps the output, evidence, review history, and signature together | Record packages you can produce on request |
| Part 11 | Trustworthy electronic records and signatures | Part 11 electronic signatures and an append-only audit trail | Audit trail and signature manifestations |
Data integrity you can show an investigator
Reviewers see the records, requirements, and evidence behind each finding instead of a bare conclusion. Missing evidence and unresolved issues stay visible rather than buried in an AI response.
Ovada provides
- Defined workflows with set triggers, checks, and outputs
- The requirements and document versions tied to each decision
- The same checks and review steps on every run
- An append-only audit trail of every action
Your team owns
- Approving procedures and specifications
- Reviewing every finding
- Every regulated decision
- Every signature, under Part 11
GMP compliance for supplements and pharmaceuticals
Pharmaceuticals · Part 211
Component testing, investigations, record review, and quality unit authority. Read the Part 211 guide.
Ovada works with the GMP software you already run, alongside your validated QMS rather than replacing it. See how it compares with traditional QMS software, browse the skills it performs, or review security and validation.
Frequently asked questions about GxP compliance software
01What is GxP compliance software?
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GxP compliance software supports regulated work under good practice rules such as GMP, GLP, and GCP. For manufacturers it typically covers quality procedures, records, investigations, and approvals, with the validation, audit trails, and electronic signatures regulators expect.
02What is the difference between GxP and GMP?
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GxP is the umbrella term for good practice regulations. GMP, good manufacturing practice, is the part that applies to manufacturing, such as 21 CFR Part 111 for dietary supplements and 21 CFR Part 211 for finished pharmaceuticals.
03Does Ovada replace our QMS?
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No. Your validated QMS remains the system of record. Ovada works across it and your other systems to do the evidence-heavy work behind GMP records.
04How does Ovada support data integrity?
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Every finding links to its source records, actions are captured in an append-only audit trail, and regulated decisions are signed by qualified people with 21 CFR Part 11 electronic signatures.
Keep GMP work controlled as you automate it
Bring one regulated workflow and see how Ovada keeps its evidence, review, and sign-off traceable.