Solutions

Simploud is more than a quality management system—it’s a holistic approach for managing the full life cycle of your quality system.

The processes of designing, building, validating, using, and continuously improving your quality management system are all built into Simploud. Switching your quality system has never been so

easy—and our results will take your business to the next level.

Change Control

To ensure that there is no impact to your business during a change implementation, it is crucial to go through a set of formal steps and actions. You must review and verify that, when planning a change to your equipment, material, process or procedure, you’re not compromising the quality of your product. Simploud makes sure you follow the steps defined in your SOP’s without missing anything along the way.

Document Control & Training Management

Your controlled documents (SOPs, policies, work instructions, etc.) are stored in one centralized location. Our robust access control makes it easy to manage templates and revisions. In addition, because of the innovative way that Simploud connects documents  to trainings, your company can achieve compliance with a few simple settings. Each employee is matched with the relevant training assignments based on role, location, or any other

attribute—ensuring your teams are always audit-ready and compliant.

Complaints

Simploud tracks any complaints about the identity, quality, durability, reliability, safety, effectiveness, or performance of your product. Our simple tracking system allows you to ensure there are no incomplete tasks, comply with stringent regulations, and ensure brand protection. Simploud offers a plug-and-play solution to allow automatic complaint intakes into the system.

Quality Events

Any deviation from your specifications can be easily managed in Simploud, where you can maintain many-to-many relationships between objects. This flexibility provides greater visibility into previous event occurrences, and allows you to anticipate the possible consequences of every event across your company and supply chain. ​By regularly conducting thorough investigations, you’ll consistently display evidence-based decision-making— the dream of every quality professional.

CAPA

Corrective and preventive action helps organizations eliminate the causes of non-conformities or other undesirable outcomes. In Simploud you can link CAPAs to Quality Events, Complaints, and Audits, thus enabling a prompt resolution and demonstrating your company’s  commitment to addressing issues and prevent recurrences.

Audits & Inspections

By managing the outcomes of supplier audits, internal audits, and incoming inspections, you can ensure that the conclusions of these performance measurements are being addressed. Outcome management is crucial for your company’s success—not only internally, but with your supply chain, as well. In Simploud, everything is linked, including your observations to CAPAs and actions, so that you can readily identify and prevent anything that would cause an adverse outcome.

Supplier Management

Your CROs, measurement and calibration equipment, IT/software, couriers, and other key GxP vendors in your supply chain must adhere to your quality standards. Simploud allows for seamless collaboration with all of your vendors. It’s transparent, efficient, and simple.

Product Registration

Every product you manufacture and distribute has to be registered in every country in which you plan to sell. In addition, you must manage renewals and variations throughout each product’s lifespan. In Simploud you can easily monitor all registration-related information, set reminders, and make sure you don’t miss any deadlines so that your products remain in good standing wherever they are sold.

Risk Management

There are two types of risk management elements in Simploud.

  1. A built-in risk mechanism that you can add to any quality area to help identify potential compliance risks based on previous cases. While it is often difficult for individual users to see the big picture-causing them to miss potential risk elements-Simploud keeps track of everything. It will help you avoid risk by pointing out previous cases you can learn from.

  2. A mature risk assessment quality process that follows the evaluation of predefined risk elements for a specific quality record.

Design Control (DHF, DMR, DHR)

From the earliest phases of the device design process all the way through manufacturing and distribution, all aspects of the design, plans and records must be documented. Simploud ensures that you can access the most updated documentation and methods and allows you to record real data against the required specification.

 
 
 
 
 
 
 
 
 

Environment, Health and Safety

The legal and regulatory implications of a poorly managed Environmental Health and Safety (EHS) program can be disastrous in terms of personal injuries, shareholder confidence and litigation. Local, national and international agencies require extensive reporting on both prevention plans and the occurrence of environmental or safety issues. Simploud captures all the necessary data, provides extensive KPIs and allows reporting to the relevant authorities.

 
 
 

Equipment and Calibration

Equipment used to manufacture drugs and medical devices must be validated and maintained per schedule provided in the equipment procedure (SOP). Simploud manages all company assets and their ongoing maintenance tasks in a consolidated way and ensures that all the company assets are validated and maintained on time in a proper way.

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