Advertisement QMS (SOP, Non-Conformance, CAPA, Audits Customer Claims) - Pharmaceutical Business review

Advertisement

Pharmaceutical Business review is using cookies

ContinueLearn More
Close
close icon

ENNOV

Medical Device and Drug Development Compliance Specialists

More info about ENNOV

QMS (SOP, Non-Conformance, CAPA, Audits Customer Claims)

ENNOV

SOP

Controlling your SOPs procedures aims at improving final product quality, ensuring people and installations safety, reducing costs and timely delivery. To achieve such a goal in a cost-effective way, Ennov provides an all-in-one solution to manage quality documents, improve procedure awareness, streamline appropriate workflows and finally track deviations in order to continuously improve your system.

Ennov5 documentation database: a business knowledge tool

Before you can control whether procedures are correctly applied throughout the company, you have to find a way to increase employees’ awareness and access to those documents. Ennov integrates complete management of updated and validated procedures, ensuring selective distribution to employees and sub-contractors over the Intranet or the web. Return receipts are collected and securely stored in order to prove peoples’ awareness. Team leaders are automatically notified of updates. Documentation is made available to all employees through free-access workstations.

Ennov5 wokflow engine – strict execution of flowcharts described in procedures

Ennov5 provides quick and simple workflow design and set-up, hence automating application of in-house procedures throughout the company. When entering information in the system, employees record their daily tasks in accordance with their job description. Once finished a task initiates an automatic notification to the next person in line and immediate transmission of due data. Overseeing a step or forgetting to notify a recipient is made impossible. The workflow is executed according to corporate standards and requirements. Losses of time and information are avoided and key information is securely stored for further analysis.

Ennov5 procedure control

When a workflow executes issues might occur. A workflow might be late, at a standstill or inappropriate. Real-time dashboard allows you to check workflows statuses: how many are in progress, at what step in the process the workflow is, how many need further investigation and how many workflows have come to an end. With Ennov5 it is easy to group workflows by a variety of different meta-data requirements and analyze process performance to determine bottlenecks and promote organizational efficiency. As a whole the Ennov workflow database is an excellent knowledge base to giving insight to those business processes that impact the bottom line.

Having deployed such a measuring and controlling tool for their activity, manufacturing companies can easily and in a cost-effective way promote Six Sigma practices and continuously drive down costs.

Non-Conformance

Quality management and process control implies rigorous management of non-conformance and deviations. All manufacturing processes can afford detection and correction of a deviation when still in the design phase, but will be dramatically harmed if production needs to be stopped or products recalled, once products are distributed and sold. Rigorous management of deviations is a major issue for it helps companies meet their deadlines and cost objectives for product releases.

Basic principles about non-conformance management

Managing non-conformances is a multi-step process:

  • Reporting: should be easy and made accessible to as many employees as possible
  • Qualification and treatment: should be done by the appropriate people according to the type of problem detected
  • Correction: should be proposed as soon as possible
  • Test and validation: make sure correction will not generate side-effects
  • Implementation: should be achieved as soon as possible
  • Objectives for such a treatment are three-fold: account for all non-conformances, avoid doing the same job twice and correct problems while minimizing financial impact

Benefits of a computerized system: Ennov5 Process

Based on a workflow engine a computerized system for managing non-conformances will help you throughout the process. Automatic recording of all non-conformances detected:

  • Centralized database secures information
  • Electronic processing according to pre-defined workflows
  • Responsible parties are automatically assigned and notified
  • Deadlines monitored up to closure
  • Audit trail of entire process execution

Reduce risk by enforcing consistent and validated corporate policies, no overlooking of mandatory steps, such as effectiveness measurement or closure.

Computerization brings about qualitative benefits as well. On line, user-friendly, customizable interface that replaces cumbersome paper forms turns into an increased number of non-conformances reported. Such an increase helps companies proactively check their processes and re-engineer those open to improvement. Last but not least, Ennov5 strengthens collaboration: every employee responsible for action is automatically notified and can check on line a complete listing of all tasks to be performed.

Obviously, Ennov5 will not substitute human understanding and investigation to automatically solve problems but it is the perfect backbone to streamline non-conformances, ensuring a complete follow-up on detection, transmission, consolidation and control. It is a great tool to decrease time cycle and lower production costs.

The Ennov5 plus

Ennov5 offers additional features to allow for efficient and proactive monitoring of non-conformances. Managers have access to complete viewing of undergoing processes by status. Customizable alerts can be sent whenever a deadline expires. During an audit, follow-up on actions can be proved thanks to on-line tracking. Thanks to its exhaustive and flexible features Ennov5 is a great success with major companies for processing their non-conformances, customer complaints, deviations or even issues on projects.

CAPAs

Managing action plans is a day-to-day activity throughout any company. Good meetings start with a close examination of the last action plan, then lead to the set-up of a new action plan. All difficult problems, adverse events and deviations are submitted to investigation and close definition for creation of an action plan (CAPAs). But how many of these action plans are correctly followed up? How can one eliminate potential loss of information? Is there a way at a glance to measure how actions are being performed and what their status is? Who is in charge? Are deadlines met? Is effectiveness measured? To answer these questions and many others Ennov proposes its Ennov5 Process solution.

Computerizing your system: What benefits?

A paper-based system is not an adequate solution when supervising long-term action plans that may go on for months, even years. Electronic recording is the only way to prevent loss of information, oversights, to track tasks performed, responsible parties and effective dates. The more important the project is, the longer the list of actions. Nevertheless, managers need at every moment to have a global picture of actions in progress. Who is responsible? What is the status? When is the due date? In case of management reviews, quality reviews and product quality reviews even more details will be needed as well as associated documents. Ennov allows this double-sight analysis with specific details as well as the global picture.

For a more rigorous, less complicated compliance to corporate policy

Many situations can lead to setting-up an action plan (meetings, projects, audits, customer complaints, etc.). As a consequence, it is essential for software handling action plans to be widely accessible to the largest number of employees. Set up should be easy and interfaces should be user-friendly as it is with Ennov5. Workflow definitions are easily configured allowing for different paths of processing according to the specificity of actions. Ennov5 offers the ability to configure as many types of workflows as necessary. This allows the responsible parties the choice of the appropriate workflow. Moving from one step to the other, associated emails and alerts are automatically monitored by the system itself. The Ennov5 centralized database consolidates ongoing CAPAs resulting from different sources, so as to increase transparency and visibility for managers.

Day-to-day automatically updated dashboards

With its reporting module, Ennov goes a step beyond the simple follow up of actions. Its data mining capabilities allows for multi dimensional analysis on actions performed. Criteria might range from site, country, unit, to average resolution time, delay, etc. This tool proves itself very useful to improve quality trending.

Keeping track of all actions, successes as well as failures, Ennov5 is a wonderful knowledge tank, where stored information is made ready for analysis. The more the system is used, the more convenient it is to propose the right piece of information on the occasion of an audit. Ennov5 becomes an electronic memory for the whole company’s activities.

Audits consist of measuring and documenting the compliance of selected processes to regulatory standards. Audits may concern a department, a production line, a supplier, etc. In most cases, they are organized in order to gain a certification, or to renew it periodically. Audits usually involve collaborative work between managers, experts, quality engineers and others. In this context, Ennov5 offers key features to optimize the organization of audits and harmonize auditing methods.

Ennov5 handles all the phases of the audit

Audit scheduling is a very time consuming task. With Ennov5, you can easily plan dates, book auditors for each domain, according to their availability, and notify responsible department personnel of pending audits via system generated emails. You can determine resources required and time to accomplish tasks. This can also base line future audit expectations and assist in managing costs of audits.

During the audit, you directly access the corporate quality documents in Ennov5, this is the most efficient way to check each item in real-time. The auditor raises findings in the system, and consolidates his/her remarks in a report that is automatically generated at the end of the audit, based on a predefined template. The report is then distributed electronically to all persons involved, who will agree on a corrective action plan(s).

Follow-up of corrective actions is ensured using Ennov5 workflows defined for each type of action. At any time, auditors have a clear view of on-going actions; they can remind the persons responsible if necessary. Each corrective action is closed once all appropriate steps have been completed. When all actions are closed, the audit can be declared completed as well.

Ennov5 helps you save time and improve methods

Ennov5 benefits can be summarized in four points:

  • Audit scheduling is faster, so you can focus on the audit itself instead of taking time to organize it
  • Quality documents and audit reports are managed in the system repository, you can find them very easily
  • All documents and sub processes used in the audit such as SOPS and corrective actions can be linked to the audit so you may review them without leaving the navigator
  • Corrective actions are traced so that you can monitor the progress made and meet deadlines – your quality system is then globally improved

Customer Claim Management

The quality of the service delivered by a company is measured by the efficiency of its procedures to deal with customer claims. Often the procedures to handle customer complaints require the coordination of many people within an organization. The ability to document and make the information available to all contributors is essential in providing the correct and expedient resolution.

As many people may act in providing the resolution, it is imperative that you are able to manage each person’s performance within the process and track the complaint all the way from origination to resolution. Once this effort has been performed an organization can retain these results and use them to improve internal processes and look for ways to provide better customer service and prevent repeat occurrences. Ennov5 is the one solution that can accomplish all these aspects and improve customer quality delivery. This is a critical factor to build a long term business relationship based on mutual confidence.

Ennov5, an efficient CRM solution

Electronic management of customer claims is necessary in order to save time in the course of the processing:

  • Send a return receipt to the client as soon as a complaint has been raised
  • Keep track of all communication exchanged between customers and contributors (emails, scanned letters, documents sent)
  • Start immediate corrective actions (stop a production line or a batch delivery, internal/external alert)
  • Follow up progress made in the corrective action plan and keep the client informed
  • Make sure a formal validation is done before closing the customer claim
  • Manage and trace all corrective and preventive actions launched
  • View all complaints raised by product, by type, by customer, by period, by region/site, etc.
  • Produce quality indicators in order to monitor and improve operational performance

Ennov5 includes all these features; it is a comprehensive CRM tool that can be deployed within a short period of time to provide critical coordination for companies who value customer loyalty and want to streamline customer complaint resolution and process improvement.

Monitoring contract requirements with Ennov5

Most service level agreements indicate deadlines to process customer claims, they are associated with strict financial conditions (maintenance cost, penalties, etc.). It is then important to provide evidence on the processing times and responsibilities in the workflow. Ennov5 package enables your company to track this information. The return on investment is outstanding.

Quick Contact QMS (SOP, Non-Conformance, CAPA, Audits Customer Claims)