Pharmaceutical quality

Pharma quality management software that does more than store and route records

Ovada is an AI quality agent for pharmaceutical CDMOs and sponsors. It applies approved procedures and specifications, gathers evidence, coordinates follow-up, prepares review-ready records, and routes every decision to qualified people.

See Ovada work a pharma workflow Explore continuous quality monitoring

Teams#production

DEV-2291 · granulator 2 log for the investigation

OvadaMon 22 Sep

Marcus, for DEV-2291 I need the granulator 2 equipment log from 15 Sep 22:00 to 16 Sep 06:00. Could you export it?

Investigation · 21 CFR 211.192

Marcus LeeMon 22 Sep

Here you go.

GR2_log_16Sep.csv

OvadaMon 22 Sep

Thanks. This log starts at midnight on 16 Sep. Could you include 15 Sep from 22:00?

Follow-up · same day

Marcus LeeTue 23 Sep

Full window attached.

GR2_log_15-16Sep.csv

Ovada · checked the reply

Log starts 16 Sep 00:00. The deviation window opens 15 Sep 22:40.

Ovada · checked the reply

Full window covered. Timeline rebuilt. 2 more batches in scope.

Linked to the investigation

Quality workflows Ovada supports

Pharmaceutical quality work extends beyond the QMS. The system of record preserves the final record, but your team still does the work between systems: finding evidence, applying procedures, chasing inputs, and preparing the package. See how Ovada compares with traditional QMS software.

Deviation management

Investigate discrepancies the way 21 CFR 211.192 expects, extended to every batch that may be affected.

CAPA management

Gather evidence across sites and sponsors and draft actions for quality unit approval.

Incoming material disposition

Compare supplier CoAs with the right sponsor specification, with identity testing tracked per component lot.

Supplier quality management

Keep component supplier qualifications and the CoA reliance behind them current.

Continuous quality monitoring

Watch procedures, quality agreements, and FDA observations for changes that reopen a gap.

These are five of Ovada’s 62 skills. The ones that matter most depend on your operation. See all 62 skills.

Part 211, mapped

How Ovada supports 21 CFR Part 211 quality operations

Where the regulation meets daily work at CDMOs and sponsors, what Ovada takes on, and who decides.

21 CFR Part 211 requirements mapped to daily quality work
Requirement	The daily work	What Ovada does	Who decides
211.22 · Quality control unit	Approve or reject components, procedures, and batches	Prepares each decision with the evidence attached	The quality unit
211.84 · Component testing	Test each component lot, with at least one identity test	Compares supplier CoAs with the right specification and tracks identity testing per lot	The quality unit
211.100 · Written procedures	Follow approved production procedures and record any deviation	Checks records against the approved procedure and flags deviations	The quality unit
211.192 · Record review	Review records before release and investigate unexplained discrepancies, extended to other affected batches	Reconstructs the event and drafts the investigation across affected batches	The quality unit
211.198 · Complaint files	Review complaints and decide whether to investigate	Assembles the complaint and related batch records	The quality unit

Part 211 governs manufacturing quality. Part 11 governs electronic records and signatures. Ovada addresses both, and it never replaces the quality unit or its accountability. See how GxP compliance software keeps that work controlled. For the requirements themselves, read the subpart-by-subpart Part 211 guide.

Pharmaceutical CDMOs and sponsors

For CDMOs

Run repeatable quality work across many sponsors while keeping each customer’s specifications, quality agreements, and internal controls intact.

For sponsors

Gather evidence across outsourced activity, prepare review-ready records, and keep qualified oversight. Delegated work is never delegated accountability.

Frequently asked questions about pharma quality management software

What is pharma quality management software?

It is software that helps pharmaceutical companies manage controlled documents, quality events, investigations, CAPAs, suppliers, approvals, and audit history. Ovada adds an AI quality agent that does the evidence-heavy work across your connected systems.

Does Ovada replace our validated QMS?

No. Your validated QMS, document repository, or other designated platform remains the system of record.

Can Ovada support CDMOs and sponsors?

Yes. Ovada is configured around each organization’s procedures, customer requirements, specifications, quality agreements, and authorization paths. Sponsors keep their oversight responsibilities and accountability.

Is Ovada a substitute for the quality unit under Part 211?

No. Ovada performs the controlled work leading up to decisions. Qualified personnel keep judgment, review, authorization, and accountability.

How does Part 11 relate to these workflows?

Part 211 covers pharmaceutical manufacturing quality. Part 11 covers electronic records and electronic signatures. Ovada is 21 CFR Part 11 compliant, so the electronic records and signatures in these workflows meet both.

Complete more pharmaceutical quality work before it reaches the reviewer

Bring one repetitive, evidence-heavy process and watch Ovada do the controlled work leading up to sign-off.

See Ovada work a pharma workflow See how Ovada works