Solutions

Preconfigured solutions to get you started in the right direction. Digitising your quality system has never been easier, and the results will take your business to the next level.

 
 
 
 
 
 
 
 
 

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.

Complaints

Enable your customers to easily log Complaints in Simploud community portal, chat with them within Simploud to get a better understanding of the issue, and use Simploud's advance investigation tools to identify root cause, to determine reportability, and to respond to customers. Let us help you close complaints faster.

Controlled Documents

A single location for all of your controlled documents (SOPs, policies, work instructions, etc.). Enable easy access to effective documents and its related training activities, and let Simploud handle document revisioning and maintenance for you.

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.

Change Control

Changes are part of life and are an opportunity to grow and improve. The trick is to implement Change Requests without causing negative impact to your business. Simploud will help you go through the necessary process of planning and approving the change as well as help you monitor its implementation.

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.

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.

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.

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.

Design Control

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.

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.

Training Management

Help your employees stay fit for their work and ensure timely training for controlled documents and training materials. Let Simploud's automated training engine to manage training activities according to predefined rules, and review the state of training in an accessible and simple training matrix.   

 

Batch Release

A centralized solution to help you release batch faster and with increased compliance. Record tests online, submit to QP approval and release batch at a click of a button. 

 

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