QMS and PLM Implementation
We use a variety of best-in-class tools from basic document management technologies to state of the art product lifecycle management (PLM) technologies to achieve this. Integware has a proven track record in delivering these kinds of solutions across the board in both the US and international locations as well as experience scaling from small and large companies.
As an example, Integware was the premium service provider to one of the largest and most successful PLM programs in the world (likely the largest ever in the medical device industry) between 2008 and 2012 and have been implementing PLM and QMS solutions since 1993.
We have also automated the product lifecycle for smaller, “mid-range” companies. As such, we understand that not every company can afford or is willing to take on the complexities of a full enterprise system and we can offer solutions to fit the budget of most companies.
The platforms we use fall into two distinct groups; these can be scaled to your organizations budget and current need for automation:
Fully Integrated Product Lifecycle Management Solutions: These include market leading technology from Dassault Systemes ENOVIA, PTC, Oracle/Agile and Siemens. From these platforms, Integware can help select and implement the most fitting to best meet your QMS and product lifecycle automation needs.
Document Management Systems: Several popular “document only” management systems exist and can provide a basic foundation to managing the product lifecycle. For example, we can support some basic QMS needs using Microsoft SharePoint. Suitable typically to smaller organizations, this represents an easy to implement and low cost option for basic document management. As your organization grows it will be necessary to upgrade to a traditional PLM system.
To implement these solutions Integware has an out-of-the-box methodology and uses tools to support out-of-the-box style implementations.
We have deep technical expertise and offshore resources to implement cost effective extensions to software, but we prefer and steer our customers away from upgrade-risky customizations.
Validation Services
Integware is experienced in the process of validating an electronic system for production use. For this purpose we provide:
- Requirements
- Test Cases
- Requirements Trace Matrix
- PQ (Performance Qualification)
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- DMQ (Data Migration Qualification) - (If applicable)
We facilitate the validation activity with end-users from our customer organization who sign off on test reports prior to go-live.
Data Migration Services
Moving data from your legacy or paper system into an electronic system can be a challenging and cumbersome undertaking. Integware has many years of experience and expertise in this type of work.
Integware will work with the customer to provide a data migration strategy that includes identification of all sources of information, a protocol to cleanse the information (including the development of automation tools), loading, validation strategy and interface with the deployment plan.
Once the strategy is completed, Integware will work with your organization to execute the data migration strategy. This is a part of the project that is carefully managed and can often be the critical-path to go-live.
Integware brings a set of tools and best practices (varies depending on the destination technology) to perform this work.
During the project Integware develops or updates product training manuals or provides addendums to existing ones to match the customer configuration. During the deployment phase of the project, Integware provides either “train-the-trainer” or end-user training classes to help ensure organizational adoption.