Regulatory & Customer Compliance

Simplify Compliance, Audits, & Reporting

Deliver the evidence of a properly controlled process

Automate compliance with even the strictest of regulatory requirements eliminating associated costs and delivering total evidence of a product’s entire build life through a single system.

types of regulatory & compliance categories
types of regulatory & compliance categories

Explore the features and benefits

STREAMLINE AUDITS

DATA RECORDING & FULFILLMENT

REVISION CONTROL

DIGITAL BUILD HISTORY & TRACEABILITY

ITAR & ACCESS CONTROL

VALIDATION READY

SECURITY AND ENCRYPTION

System Wide Digital Audit Trail and E-Signature

From the approvals for documentation and processes prepared for the factory, to every action performed by operators at their workstations in the factory, a rich digital audit trail is naturally maintained to readily answer the most challenging circumstances.

FactoryLogix positively confirms an individual’s acknowledgement and actions through electronic signature, meeting the standards for FDA 21 CFR Part 11 and other stringent regulatory environments.

auditor
auditor

Automate and Optimize Reporting

Transform your present compliance reporting methods, likely reliant upon paper and scattered data silos, to a core single system automating your operation’s data fulfilment to satisfy AS9100, FDA 21 CFR Part 11, GAMP, ISO, and others.

FactoryLogix reduces (and often eliminates) the time, hassle, and resources required to deliver comprehensive report detail and other digital content, whether routine, or on-demand, with friendly report creation and reusable templates.

Collage of reports and data collection
Collage of reports and data collection

Enforcement and Evidence of the Part & Process

FactoryLogix manages both the revision of ‘what’ you are building, but ‘how’ you built it—all under revision control. The concept of BOM/Assembly revisions in conjunction with process revisions provides the full history of everything about how and what you manufactured and makes it all available for instant auditing. In addition, it enforces these revisions to ensure when you do execute an audit, you have the confidence everything was done properly.

Revision control screen
Revision control screen

The Evidence of a Properly Controlled Process

In the event of an audit or recall of mission critical products, full product and process traceability must be available through a device history record (DHR).

FactoryLogix is built with granular traceability at its core, instantly returning dynamic electronic device history records (eDHR) reflecting the entire scope and genealogy of your well controlled operations for every completed product.

Trace Screen
Trace Screen

Combination of Role & Product Security

Restricts access to product information based on security level of the person and the nature of the product being built.

Can have ITAR and non-ITAR co-existing and still be in compliance with ITAR.

Screen showing operator is not certified to work on product
Screen showing operator is not certified to work on product

Designed to Make Validation Simple & Successful

FactoryLogix was designed ground-up with GAMP5 practices in mind, both functionally and in development and QA methodologies. In addition, the capabilities related to functions such as electronic signature security and data quarantining were all engineered with validation in mind. Your assurance that the validation of the solution in your manufacturing environment will proceed expeditiously and end in success.

Validation Ready
Validation Ready

Control Your Digital Manufacturing Network

FactoryLogix 128-bit encrypts all network communications between its business logic servers, portal applications, cloud servers. All data ‘over the wire’ is at the highest level of network security currently available.

Security and Encryption
Security and Encryption

FactoryLogix: Traceability
Videos

FactoryLogix: Traceability

Reduce In-Process Costs - Eliminate Recalls - Meet Regulatory Requirements.

Control Costs, Ensure Product Quality, Shorten Time-to-Market, and Simplify Compliance with Confidence.

Some other clients we’ve helped

Celestica
Celestica
Chart
Chart
GE Aviation
GE Aviation
Ametek
Ametek
Intel
Intel