Library
The PIF, held continuously
The Product Information File assembles continuously and stays retained ten years after the last batch placed on the market, instead of being pulled together under pressure.
IndustriesCosmetics
• Cosmetics
The Product Information File held continuously
The PIF stays current instead of being assembled under pressure. Ingredient restrictions are checked against live annexes, and registration clocks run on their own.
Supported frameworks, not certifications. Regulatory updates included.
The formula is the source of truth.
- 01Formula version
- 02Ingredient limits
- 03Approved master
20 configured controlsISO 22716:2007 · MoCRA · Regulation (EC) 1223/2009
One controlled record
Why now
The obligations arrived
before the GMP rule did.
MoCRA lets the FDA write a cosmetic manufacturing practice rule. It is not published yet, but the rest of MoCRA is already enforced.
- Already in force
Facility registration, product listing, safety substantiation and serious adverse event reporting.
- Adverse events are public
Since September 2025, reports are searchable by product name.
- Build to ISO 22716
It carries a presumption of conformity in the EU. India’s Schedule M-II is thinner, so Factro treats it as a subset.
What is tailored
The file is always ready.
So is the formulation.
Where the Cosmetics pack changes how the core behaves.
Inventory
Retained samples as stock
Retained samples are tracked as inventory, with location, quantity and parent batch, not a shelf someone remembers.
Quality
Restrictions checked live
Ingredient restriction checking runs against live annexes, flagging every affected formulation the moment a substance is added.
Built for cosmetics
The formula on the line is the approved one.
And the file proves it.
These features switch on with the cosmetics pack, on the same record as production and quality.
01 / Controlled documents · Formula revisions
One effective revision, on every shift.
Each formula revision goes through review and approval before it takes effect. Operators work from the effective revision, and every batch links to the revision it ran on.
- 01Approved before the line.
A new revision runs through change control, review and approval. Until it takes effect, the line keeps the current one.
- 02One revision on every shift.
When a revision takes effect the earlier one is superseded, and training on it is reassigned to the people who use it.
- 03Every batch names its revision.
Each batch links to the revision it ran on, so an investigation starts from the right formula.
02 / Library · Registrations and labelling
Registrations and labels, per market.
Each product keeps its permissions, registrations and labelling requirements by market, on the catalog record. The Product Information File draws on the same record instead of a folder.
- 01Every market on one record.
Licences, notifications, listings and registrations sit on the product with their validity, market by market.
- 02Clocks that run themselves.
Each registration renews on its own date, and regulatory affairs is alerted with time to act, not after it lapses.
- 03The PIF stays current.
The Product Information File draws on the same record and is retained ten years after the last batch placed on the market.
03 / Inventory · Retained samples
Retained samples, tracked like stock.
Retained samples are logged at release with a location, quantity and parent batch. Every pull is recorded, and alerts come as a sample nears the end of its retention period.
- 01A place and a quantity.
Each sample is logged at release with its cabinet, shelf, quantity and parent batch, not a shelf someone remembers.
- 02Every pull is a movement.
Taking a sample for a complaint or a test lowers the quantity and keeps the reason on its history.
- 03Alerts before retention ends.
Samples nearing the end of their retention period are flagged, so disposal is planned with QA.
04 / Quality · Ingredient restrictions
A new restriction finds every formula it touches.
Ingredient restrictions are checked against live annexes. When a substance is added or restricted, every affected formulation is flagged for review, with its level beside the limit.
- 01Checked against live annexes.
Restrictions come from the annexes in force, from EU Regulation 1223/2009 to IS 4707, not a list copied last year.
- 02Every formulation, flagged.
An annex update flags each formulation that uses the substance, so nothing waits for someone to remember it.
- 03Review, then change control.
Each flag goes to an owner for review, and a reformulation runs through change control like any other revision.
India licensing, built in
Forms, clocks
and renewals in one place.
The pack holds the licence register, the renewal clocks and the Schedule M-II batch record fields inspectors review first.
Manufacturing licence
- Apply onCOS-5, or COS-6 for a loan licence
- Granted asCOS-8 or COS-9
Granted within 45 days. Perpetual after that, with a five-yearly retention fee.
Import registration
- Apply onCOS-1, through SUGAM
- Granted asCOS-2 certificate
The registration certificate that covers imports.
Secondary registration
- Apply onCOS-4
- Granted asRegistration
Valid for three years, with the renewal on its own clock.
New ingredient approval
- Apply onCOS-12
- Granted asApproval
Needed before the ingredient is first used in a formulation.
Controls
20 controls.
6 standards.
Every control below runs on the Compliance Engine. The same record carries the evidence across the plant.
Also mappedISO 11930:2019
15 controls shown for ISO 22716
Append-only, hash-chained audit trail capturing old value, new value, author, time and reason
Product Information File assembled continuously, retained ten years after the last batch placed on the market
Ingredient restriction checking against live annexes, flagging every affected formulation when a substance is added
Batch manufacturing records in the Schedule M-II shape, carrying quantity required against quantity actually used
Retained samples tracked as inventory, with location, quantity and parent batch
Stability and challenge testing results bound to the shelf life and period-after-opening claim
Preservative efficacy testing to ISO 11930, with results attached to the formulation version
Role-based access control, down to the individual field
Segregation of duties enforced in the system, maker is never checker
Change control across formulation, supplier, process and label
Internal audit scheduling with findings routed to CAPA
Out of specification handling with investigation and disposition
Complaints and recall procedure with classification and effectiveness checks
Subcontracting control with written scope and qualification records
Training tied to document version, reassigned on every revision
Regulatory change
We watch the rules.
You do not have to.
The Compliance Engine tracks the rules that apply to you, works out what a change touches, updates the system and re-validates before release. You file no change request.
- • applied
EU Cosmetics Regulation 1223/2009 applies
The regulation became fully applicable, introducing the responsible person, the Product Information File and cosmetic product safety reports.
- • applied
MoCRA signed into law
The Modernization of Cosmetics Regulation Act gave FDA new authority over facility registration, product listing, safety substantiation and mandatory recall.
- • applied
Public adverse-event search absorbed
MoCRA adverse events became searchable by product name; the pack's serious adverse event intake already ran on the 15-business-day clock it needed.
- • applied
MoCRA obligations
Facility registration on a two-year renewal, annual product listing, safety substantiation, serious adverse event reporting and FDA mandatory recall authority.
- • applied
IS 4707 Part 2:2025 in force
Replaced the 2017 prohibited and restricted ingredient standard in India. Part 3:2025 on permitted preservatives took effect 9 August 2025.
- • applied
EU Omnibus Act VIII applied
Non-compliant stock had to be off the market.
- • upcoming
EU Omnibus Act IX applies
Carrying new CMR classifications and recent scientific committee opinions.
Validation readiness
Controls built in,
not configured on top.
Validation packs
Available on the Dedicated tier, mapped to your workflows. URS, IQ, OQ, PQ, RTM and GAMP 5.
ISO 27001
Certification in progress. Encryption, access control and backups are described on Security & Trust.
Readiness, scored
The Compliance Engine scores inspection readiness continuously, with guidance on each open gap.
Make it your workflow
Have a requirement
to walk through?
Bring the regulation that keeps you up at night. We will show you the control that answers it, on a batch from your plant.