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1. Shouldn't we wait until we develop our business processes first before picking solution to deploy?
2. What are the advantages of implementing a configurable system?
3. Are you a Commercial off the Shelf (COTS) solution?
4. How would your system fit into our current (as well as future) system landscape - specifically, will
it be able to evolve and integrate with new systems that come on-line?
5. What are some examples of systems that you integrate with?
6. Why shouldn't we just use a traditional ERP or MES from Commercial Manufacturing to address Pharmaceutical R/D needs?
7. How does Conformia work to ensure its solutions are the right ones for potential customers?
When it comes to software implementations, the common perception is to wait and develop the business processes before picking a system to deploy. Conformia's approach involves simultaneously developing the business processes while configuring the system solution to meet the needs of the client.
Doing so provides a number of advantages - not the least of which, ensures the client will end up with a system that meets its needs but also, fosters an approach that compares current practices (manual and automated) against best practices process design. (Ensuring the best possible requirements will be designed to map against the system).
Through Conformia's wealth of best practices reference points (representing the complete spectrum of development processes from campaign planning, materials management, technology transfer, etc.) empowers the organization to achieve the following benefits:
- Balance and select the appropriate trade-offs between the "must haves" and "nice to haves" against defined timelines
- Better identify system elements to be configured to meet business process needs
Furthermore, companies that choose to treat the business process phase as a separate activity from software selection, design, and implementation face the following outcomes:
- Inevitably, clients end up customizing a large percentage of the system's functionality to meet the business processes the organization has spent months defining across multiple functions and locations.
- Business users develop manual shortcuts/workarounds to address mismatches between system capabilities and business needs; resulting frustration increases the work required to implement appropriate change management systems required to adopt the solution. In addition, workaround reduce organization's ability to achieve benefits promised by the system in the first place.
- During major change programs, an organization can easily "lose momentum" missing the opportunity to achieve the full value of the program as initiatives are delayed and/or never get off the ground.
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Conformia's Development Operations platform and associated Product and Process Lifecycle applications, are all highly configurable to ensure the business process needs and requirements can be met in an effective and efficient manner, though they come ready off the shelf with out of the box configurations to help you get started.
With rapidly growing organizations, no matter how well the business processes have been defined, they will evolve and subsequently need to be changed over time. For this reason, it is important that the system functionality responsible for managing and controlling these processes can be changed without having to program the core code of the system.
This not only allows the organization to avoid consuming valuable time and resources conducting the required validation steps with each change but also, empowers the client to make the changes required. (No need to rely on Conformia). Some examples of items in the Conformia solution that are configurable:
- Hierarchy - roles, responsibilities, organization, locations, etc.
- Workflow process actions and states
- Alerts/Notifications
- Libraries - equipment, process, materials, etc.
- Workflows
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- Personal preferences
- Reports
- Publish/subscribe preferences
- Information attributes - types, units, size, valid values, etc.
- Required fields - auditable, localizable, uniqueness, etc.
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Conformia is a 100% COTS solution that is highly configurable. As such, Conformia's platform and application suites are positioned to meet the needs of any biotech/pharmaceutical development organization.
Conformia's PPLM solutions have been developed against accepted commercial practices and offers the following benefits to its customers:
| Commercial Attribute |
Description |
| Scalability |
Allows organization to roll-out and implement software in a phased manner with minimal effort; support the rapidly growing needs of biotech/pharma companies (i.e. new products, sites, partners, acquisitions, etc.)
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| Validatable |
Conformia understands regulated environments, cGxPs, software validation, and industry specific challenges; subscribes to 21 CFR Part 11 rules and regulations around electronic signatures; provide relevant documents/templates to conduct all IQ, OQ, PQ procedures required.
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| Maintainability |
Customers can expect regular updates from Conformia for the software package. Additionally, Conformia is setup to create and deliver hot patches, if required, on any version of our software on all of our supported technology stacks.
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| Usability/Trainability |
System developed based on user feedback and in-depth company diagnostics and reviews
System can be administered and managed through internal client resources; users have access to Conformia support and training resources if required.
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| Upgradeability |
Ability to add modules and functionality with limited customization to ensure value can be added with growing needs and emerging technology.
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| Supportability |
Product development and technical support are geared towards quickly identifying and resolving customer issues through a variety of interfaces and logs to assist in Technical Support.
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In addition to these COTS attributes, Conformia's software architecture is based on widely available commercially acknowledged components
- Database Server - Oracle, DB2
- Application Server - NetWeaver, Websphere, WebLogic
- Web Server - Apache, TomCat, IIS
- Operating Systems - Solaris, Windows 2003
... coupled with accepted industry standards…
- S88/95
- J2EE (EJB 2.0, AJAX-JSF, JMS...)
- XML
- Web Services like SOAP, WSDL
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One of the main advantages of Conformia's platform approach is that it not only can integrate with existing systems spanning the development landscape but also, is configured in a manner that will allow it to integrate with future implementations as well.
One of the main issues growing biotech/pharma companies face today is not just controlling and managing data but doing so in a way that avoids creating "siloed data" within the organization. While systems help accomplish the former, it is the lack of integrations between these systems that prevent the data from being shared across the company in an efficient manner - in many cases, making the data no more readily accessible than before. Indeed, users may have to spend considerable amount of time hunting down information from multiple systems to get the data they need to assemble a report or perhaps close out a deviation. As a result, users end up frustrated with existing systems (systems that were put in place to help facilitate their activities) and go back to what they are comfortable with - storing data on their desktops.
Conformia's platform not only avoids these data silos from emerging but equally importantly, prevents the continued perpetuation of these silos by providing a "data hub" that can assemble, coordinate, and distribute information to the relevant parties through a common user interface.
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Conformia has integrated with a number of existing systems to help its clients achieve greater data visibility, traceability, and accessibility. Through its open architecture, published interfaces, industry standards, and the utilization of web service capabilities, Conformia has integrated with a number of applications to ensure data is generated/communicated across the organization in a consistent manner. As a result, data - whether related to equipment, material, processes, technical reports, campaign summaries, etc. - can be pulled from multiple systems such as:
- Materials Management (i.e. SAP, JDE, etc.)
- Document Management (i.e. LiveLink, Documentum, etc.)
- Analytical Methods and results (i.e. LIMS)
- Equipment Management and Calibration (i.e. Maximo)
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Conformia's platform and applications focus on the development - specifically, capturing information generated as a drug candidate moves out of the "discovery" phase and enters commercialization. That said, the rapidly changing environment - one that requires a fair amount of flexibility while balancing structure - is not easily met via commercial solutions. These latter systems will not meet the needs of the rapidly changing development arena - whether it is capturing data coming transitioning from non-GMP to GMP processes or moving back and forth between various scale-up and scale-down studies needed to characterize specific characteristics. Some other features offered by Conformia's platform and applications that help it meet the needs of PD in an optimal manner:
- Capture large amount of data created, from different sources and types throughout
- Enable traceability across the full/complete Development lifecycle and at specific points in time critical to build Process Understanding
- Identify and organize operating discontinuities typical within PD (stop/start nature of campaigns
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Conformia understands that making an investment in a software solution is a large commitment for any organization. To that end, we have designed phased base approach which enables companies to pilot the software and realize the benefits before committing to the entire enterprise solution. Conformia also works hand in hand with each company to develop appropriate phasing strategies based on their unique situations to ensure mutual success.
If you have any questions about Conformia's solutions and how we can help your organization, please contact:
marketing@conformia.com
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ACE Case Study