Contract & Agreement Management | Kintavo
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THE PROBLEM

Your quality agreements govern the work. They live in a shared drive.

The executed PDF is scanned, wet-ink signed, and named something like final_v3_signed.pdf. Its renewal date exists in one person's Outlook calendar. The obligations it imposes — notification windows for process changes, audit rights, deviation reporting timelines — are in clause 7, and nobody has read clause 7 since it was negotiated.

When an inspector asks which supplier agreements are currently in effect and who approved them, the answer takes days to assemble — and an expired quality agreement with an active supplier isn't a filing problem, it's an uncontrolled purchasing process.

FAILURE MODE 01
Agreements lapse silently
The supplier stays active, the purchase orders keep going out, and the governing agreement expired eight months ago.
FAILURE MODE 02
Executed originals outside document control
A scanned signature page in a folder has no version history, no approval record, and no audit trail.
FAILURE MODE 03
Obligations nobody can find
You cannot honour a notification clause you cannot search for, across two hundred agreements.
WHAT KINTAVO REPLACES

The tools you use today, and what they become.

Executed agreements in a shared drive folder → Controlled documents with version history and approval records
Renewal dates in someone's calendar → Renewal windows that escalate before the expiry date
Scanned wet-ink PDFs nobody can search → Full-text search across every clause, scans included
Contract review remembered, not recorded → Scheduled reviews closed with a Part 11 signature
Agreements disconnected from the supplier record → Agreement status visible on the supplier's qualification record
Amendments filed separately from the original → One agreement record carrying every amendment in sequence
CAPABILITIES

The full agreement lifecycle, inside the quality system.

One record per agreement
Counterparty, type, scope, owner, effective and expiry dates, governing framework — with every amendment, extension, and termination notice in sequence on the same record.
Live effective status
Draft, in negotiation, executed, active, in renewal, expired, terminated — computed from the dates on the record, never set by hand and never stale.
Renewal windows with escalation
Notice periods calculated backwards from expiry. The owner is alerted, then their manager, then quality leadership — so an auto-renew deadline cannot pass unnoticed.
Executed originals under control
The signed PDF is a controlled document with version history, approval record, and retention rules — the same governance as any SOP, not a file in a folder.
Full-text search, scans included
Scanned wet-ink originals are read on upload, so a twelve-year-old paper agreement is searchable by clause alongside everything signed electronically last week.
Obligation tracking
Commitments extracted from the text — change notification windows, audit rights, deviation reporting timelines — become tracked items with owners rather than sentences in clause 7.
Scheduled periodic review
Every agreement carries a review interval. The review is a task, and it closes with a 21 CFR Part 11 signature — so the evidence exists before an auditor asks for it.
Linked to the supplier record
Agreement status appears on the supplier's qualification record. A supplier whose quality agreement has expired cannot show as fully qualified.
Clinical and service agreements
Site agreements, investigator contracts, laboratory service agreements, and MSAs share the record model — one register for everything that governs outsourced work.
Approval routing
Quality, legal, and business approvals routed in the order your procedure requires, configured in the Workflow Builder — with the approval record kept on the agreement.
Register and expiry reporting
One filtered view answering the inspector's question directly: every agreement in effect, its counterparty, its owner, its expiry, and who last reviewed it.
Complete audit trail
Every status change, date edit, amendment, and signature is attributable, timestamped, and reason-coded under 21 CFR Part 11.
IN PRACTICE

A supplier changes a process. The agreement already said what happens next.

A contract manufacturer notifies a change to a sterilisation parameter. The quality engineer opens the supplier record and the governing quality agreement is right there — active, reviewed four months ago, with a 30-day prior-notification clause tracked as an obligation.

The notification arrived 12 days out. The obligation is marked breached on the agreement record, which raises a supplier finding rather than a conversation someone will forget.

Meanwhile the change itself routes into Change Control, where the impact assessment lists the affected validation, the two SOPs that reference the parameter, and the training records tied to them.

Six weeks later the agreement enters its renewal window. The owner is alerted 90 days before expiry, the breach history is on the record, and the renewal is negotiated with evidence rather than recollection.

0
Active suppliers able to show as fully qualified on an expired quality agreement.
90 days
Default renewal notice, escalating through owner, manager, and quality leadership.
1 register
Supplier, clinical, and service agreements in one searchable, inspection-ready view.
REGULATORY MAPPING

The clauses this module satisfies.

Bring this to your internal justification. Each row names the requirement and how Contract & Agreement Management evidences it.

FRAMEWORKCLAUSEHOW IT IS EVIDENCED
21 CFR Part 820820.50Purchasing controls — documented requirements agreed with each supplier, including the obligation to notify changes to purchased product.
ISO 13485§7.4.2, §4.1.5Purchasing information and written agreements covering outsourced processes, retained as controlled documented information.
ISO 9001§8.4Control of externally provided processes, products, and services, with communicated requirements retained as evidence.
EU GMPChapter 7Outsourced activities — a written contract defining responsibilities between Contract Giver and Contract Acceptor, kept current and reviewed.
21 CFR Part 1111.10(e), 11.50Attributable, timestamped, reason-coded audit trail on every agreement record, with signature manifestations on periodic review.
ISO 22000§7.1.6Control of externally provided processes and services relevant to food safety, with agreed requirements documented.
BEFORE / AFTER

What changes on the day you go live.

BEFORE
Days to answer which agreements are currently in effect
Renewals discovered after the auto-renew date passed
Scanned originals invisible to search
Obligations honoured only when someone remembers them
Contract review evidenced by an email thread
AFTER
One filtered register, answered on screen
Renewal windows that escalate before expiry
Every clause searchable, wet-ink scans included
Obligations tracked as items with owners and dates
Review closed with a Part 11 signature on the record
HOW IT GOES LIVE

Three steps, two to four weeks.

01
Load the back catalogue
Existing agreements are imported and read on upload — including scanned originals — so the register is populated and searchable before configuration starts.
02
Set windows and routing
Your team defines agreement types, review intervals, renewal notice periods, escalation paths, and the quality/legal approval order — in the Workflow Builder, without a vendor ticket.
03
Connect it to suppliers
Agreements are linked to their supplier qualification records, so from day one an expired agreement is visible everywhere that supplier appears.

Not a silo. Part of one connected system.

{{ m.name }} shares the same data model, AI engine, and audit trail as the other nineteen modules — so its records see, and are seen by, everything else in your quality system.

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