Technology Integration - Pilgrim Software

Pilgrim Software offers a broad range of tools and applications designed to help you optimize business performance by seamlessly connecting data across your multiple business applications throughout your technology network. Pilgrim's solution provides a Web-based platform to deliver overarching, top-down, integrated compliance management that connects into your existing, back-end other enterprise applications such as ERP, MES, LIMS, CRM, SCM, HR, CMMS, PDM systems, etc., to track and manage all of your quality events. Pilgrim's Integration Framework provides a comprehensive set of tools and utilities that:

Enable integration between Pilgrim’s solution and other applications
Help organizations re-use and make available critical information
Automate processes
Leverage existing IT investments in various applications

Supporting Pilgrim’s three key solution areas -- risk, compliance and quality management – SmartSolve’s integrated technology is flexible and friendly, and has been designed to accommodate the various common integration techniques employed, such as XML/Web Services-driven integration, API-driven integration, Data File-driven integration, staging table-driven integration, in the industry for system, process and data integration.

The solution ensures real-time interconnectedness among your quality management systems by sharing data through push and pull mechanisms, assorted look-up capabilities, synchronization agents and content management adapters.

Data Extraction (Pull) - One-time data load into SmartSolve application from external source

Synchronization (Push) - On-going data synchronization between external source system and SmartSolve in real time

Look-up/Reverse Look-up (View) - Accessing read-only data in the external source system from SmartSolve application or vice-versa

Multi-event triggers (Push) - Transaction that requires synchronization of multiple business objects within SmartSolve application (e.g., creating an exception in SmartSolve along with Part synchronization)

Active Directory

Active Directory Synchronization Utility (ADU)

SmartSolve^® Active Directory Synchronization Utility (ADU^™) is a Windows-based central authentication management utility that enables you to automatically populate and update user data from your Active Directory system and synchronize it with your SmartSolve database. Active Directory Utility allows administrators to define what type of users to monitor for changes from the larger central authentication system. In addition, once the ADU detects user changes (new, deleted, modified) in your Active Directory, it automatically updates SmartSolve. ADU automatically generates a scheduled daily summary report via e-mail to your IT administrator on all user changes.

Basic information such as name, user ID, and e-mail address are all mapped directly to SmartSolve’s user profile. For modifications, the ADU provides an option to automatically accept modification of basic user information or report the changes only. In addition, deleting users from your Active Directory automatically disables login privileges within SmartSolve to prevent access.

Lower TCO through Consolidation

Active Directory Configuration SmartSolve^® ADU ensures that updates will be easy, fast and consume minimal network resources. By using the integration and relying on the data within ADU, you take advantage of existing knowledge and expertise.

Common Management Interface

With SmartSolve^® ADU being the single management console for the enterprise, there is no need for additional administrative interfaces or department-specific administrators.

Group/Organization Inheritance

The group inheritance properties in SmartSolve^® ADU reduce the amount of time needed for the system administrator to stay abreast of changes in the user community across all systems – the integration between the systems ensures consistency and accuracy.

Security & Compliance

SmartSolve^® ADU allows you to seamlessly extend the security and compliance of your Microsoft Active Directory infrastructure to your SmartSolve applications. It addresses the need for cross-platform access control and the operational need for centralized user authentication, and enables simplified, heterogenous identity management. In addition it allows administrators to better deploy and manage security policies and propagate the latest system updates.

Key Features & Benefits

Capabilities	Benefits
*Authentication System Integration*
Integration with Active Directory	Easily and quickly populates and updates user data to support enterprise-wide user management
Detect User Changes	Reduces time to update user access list after system is deployed
*User Management*
Automatic profiles	Reduces user setup time through automatic user/actor profile creation for each added user
Modification options	Let the system decide to update basic user information or report changes only
Maintain security	Automatic disablement of login privileges for deleted users streamlines security process
*Automated Processing*
Automated synchronization	Increases data integrity by minimizing human errors
Validation of transformed data prior to submission	Improves data quality with the help of data validation
Ongoing, self-sufficient process	Reduces labor through unassisted execution
Multiple synchronization options	Synchronizes on request or on a schedule
*Reports and Notification*
Error notification	Reduces administrative overhead
Visual feedback during synchronization	Provides instant feedback on progress of synchronization
Scheduled Summary Report	Allows you to easily verify the process and identify incomplete data

Adapters

Integrated Content Management (ICM) Adapter

Organizations have invested heavily into enterprise content management systems for their critical document storage, control and archival requirements across the enterprise. For companies that also require an Enterprise Risk, Compliance & Quality Management (ERCQM) software solution to address critical quality requirements, the need to reference documents stored in a third-party Content Management systems process is absolutely essential. Pilgrim offers an “Integrated Content Management” (ICM^™) Adapter for integration of SmartSolve^® with third-party Content Management solutions for increased information quality.

The ICM adapter:

Creates a bridge between the customer’s Content Management system and Pilgrim’s ERCQM platform, and
Leverages all the integration that Pilgrim has already designed into its ERCQM platform

. . . thereby providing the best of both worlds.

The ICM Adapter allows customers to trade critical document-related information such as document-specific attributes, referencing the source document information between the two systems. Information can be brought in to be referenced into the quality and compliance processes. When required, the appropriate information can be exposed to the Content Management solution.

Document Synchronization Agent (ICM-DSA)

ICM-DSA^™provides your organization with an integration tool to connect your existing document management system data with SmartSolve^® to fully leverage the native integrations built within SmartSolve. Pilgrim has already developed all of the necessary connections between Pilgrim’s Document Management solution and the rest of its solutions such as Audit, Nonconformance Management, CAPA, and Training. However, there are some customers who wish to retain their current investment in their Content Management system and want to link the relevant documents as part of the processes managed by Pilgrim’s solution. This is where the ICM Adapter comes into play.

Within SmartSolve, the ICM-DSA provides the interface to use the “controlled” documents managed in the third-party system. It allows viewing the controlled documents through a hyperlink or a copy of the physical file stored within SmartSolve. It also allows users to create or modify the document types, document profiles, document categories, references, attributes and certification information using the application’s user interface.

Linking with Pilgrim's Training Management solution, ICM-DSA provides the required list of documents in which an employee must be certified. It allows transferring automatically the document content or link to the document in the third-party document management system to facilitate the employee to view the document directly from the Training Management system.

ICM-DSA also provides the references of the controlled documents maintained in the third-party system to the other SmartSolve solutions such as Nonconformance Management, CAPA Management, Change Management, Auditing, Supplier Quality, etc.

MedDRA Adapter

Pilgrim’s Regulatory Reporting solution is integrated with the MedDRA dictionary to ease and expedite the reporting process. The MedDRA dictionary is the “standard” for adverse event Pharmacovigilance terminology. The intelligent integration capability of Pilgrim’s tool captures any version of a MedDRA term to maintain consistent terminology for reporting throughout a product’s clinical trial lifecycle. Through a seamless integration, the tool can automatically capture MedDRA terms at any point in the process and automatically populate information into the case record for annual analysis and data mining, from the lowest level term (LLT) to preferred (PT) to SOC. Pilgrim's Complaints Management solution then auto-populates the MedDRA terminology into the appropriate regulatory reports. Using the solution’s Advanced Search capability, the integration allows the user to search and select the Preferred Term/Code from the MedDRA dictionary (LLT/PT/SOC).

Agents

SmartSolve^® Synchronization Agent (SSA)

SmartSolve^®Synchronization Agent (SSA^™) is a set of flexible and configurable integration tools that allows you to electronically synchronize your organization’s key system information with the data contained in your SmartSolvesolution. Automatically synchronizing data between SmartSolveand your legacy systems reduces labor and error costs while ensuring data accuracy. With SSA, you maximize the benefits of integrated Compliance and Quality Management, allowing your organization to maximize its profits.

The SSA family of integration products includes the Master File Synchronization Agent^™, Complaint Synchronization Agent^™, Document Synchronization Agent^™ and Event Synchronization Agent^™. These products seamlessly integrate and enable complete data synchronization. Intensive, often redundant, manual duplication procedures are eliminated with SSA’s automated processes. Reducing the risk of human error improves accuracy, and rapid synchronization enables real-time visibility. Customizable synchronization and update notification scheduling capabilities keep users fully informed, and automated archiving maintains comprehensive records of data and process changes. The SSA family of products can reduce costs, maximize your data, and enhance decision making.

Master File Synchronization Agent (MSA^™)

Master File Synchronization Agent (MSA^™) is a flexible and configurable integration tool that allows you to electronically synchronize your organization’s key system information with the data contained within SmartSolve. MSA is an automated tool to synchronize your employee, customer, vendor, contacts, parts, operations and their associated costs and failures with your existing ERP,MRP, CRM or any other system to SmartSolve.

Synchronization log histories are easily viewable, either on demand or automatically, after synchronization completion via email notifications containing attached synchronization reports. Customizable frequencies can be set to run manually or automatically on a specified schedule. MSA ensures complete record keeping compliance with automatic audit trail updates whenever automatic system changes from the central authentication synchronization are made.

Complaint Synchronization Agent (CSA^™)

The Complaint Synchronization Agent (CSA^™) manages compliance with industry regulations and improves company performance by automatically capturing complaint data from web sites, customer relationship management (CRM) or other field and legacy systems, updating complaint records, and notifying complaint managers. Captured data can be sent to the appropriate complaints group and additional information -- collecting, investigations, and reporting -- can be completed. All automatic system changes from complaint synchronization are updated in the audit trail from complete record keeping compliance. In addition, CSA supports FDA CDRH’s new eMDR project for bi-directional information flow.

Document Synchronization Agent (DSA^™)

Document Synchronization Agent (DSA^™) is a flexible and configurable integration solution that will help you utilize your existing document management systems, to reference your “controlled” documents as requirements within Pilgrim’s Training Management solution and as a reference within Pilgrim’s Audit, Nonconformance, CAPA and Complaint Management solutions.

Event Synchronization Agent (ESA^™)

Event Synchronization Agent (ESA^™) is a flexible and configurable integration solution that will help you to utilize existing systems to capture events. For example, ERP systems generate information for shipping/receiving non-conformances, or SPC/LIMS systems generate out-of-tolerance/specification. The ESA transfers the events captured by other systems into SmartSolve and automatically initiates your business process workflow.

Key Features & Benefits:

Capabilities	Benefits
SSA Components
Master File Agent (MSA)	Automatically populates, updates, and synchronizes master file data
Complaint Synchronization Agent (CSA)	Captures initial complaint data, updates and synchronizes complaint record data
Event Synchronization Agent (ESA)	Captures events like shipping/receiving non-conformances or SPC/LIM’S systems out-of-tolerance/specification, and synchronizes nonconformance data
Document Synchronization Agent (DSA)	Synchronizes your existing document management systems to reference your “controlled” documents as requirements within Training Management^™ and as a reference within Audit, CAPA and Complaints Management solutions
Reduce Costs
Ongoing, Self-sufficient Process	Eliminates administrative effort for updating master setup
Automated Synchronization	Minimizes administrative effort for updating master setup
Error Notification	Reduces administrative overhead
Maximize Your Data
“What and When” Flagging	Flags and timestamps data that has been changed
Scheduled Summary Reports	Identifies incomplete data or data modifications and notifies appropriate users
Data Mapping	Maps information between systems
Enhance Decision Making
Multiple Synchronization Options	Synchronize on request or on a schedule
Automated Notifications	Synchronization update reports sent via email automatically
Automated History Log	Enables administration to track processing without on-going observation
Audit Trail	Automatically updates system changes from the synchronization process
Minimize System Dependence
Database Record Integration	No variance by upgrades/versions of software
System and Version Agnostic	Minimizes interdependency between disparate systems
Synchronization Across Multiple Architectural Platforms	Data can be shared and synchronized across multiple platforms

Connectors

SmartConnector for SAP^™

SmartConnector^™ by Pilgrim Software is a pre-built and fully supported software adaptor built on certified technology for SAP^™ interfaces, including SAP Powered by NetWeaver, that lets companies leverage their investment in SAP and utilize Pilgrim Software’s SmartSolve^® solutions to further their business’ overall quality operations.

With SmartConnector for SAP^™, your SmartSolve solution can be quickly and easily integrated with any SAP^® R/3^® or mySAP™ system through an intuitive visual environment that requires no custom programming or modification of the SAP landscape. This provides a scalable and maintainable integration solution that supports your systems as business processes and your installed SAP landscape change over time.

No Custom Programming Needed

SmartConnector is configuration based, so end users can easily customize it for their SAP landscape. Plus, it is easily and rapidly upgradeable as systems and business processes change over time. No installation is required in the SAP environment and no coding is necessary to integrate with any of Pilgrim’s Enterprise Quality modules.

Supports Bi-Directional Connections

Regardless of the version or unique SAP implementation, SmartConnector supports bi-directional connections between SmartSolve and SAP. It can be quickly and easily configured to meet the unique requirements of each implementation.

Reliable Interface

SmartConnector is a robust and reliable system capable of supporting highly available mission critical enterprise computing. Both have been designed from the ground-up to provide real-time communications between disparate applications, both within and across enterprises.

Store and Forward

SmartConnector provides persistent local data storage that allows transactional information to be temporarily stored during unscheduled external systems or network downtime. Once the external system comes back online and re-establishes communications with the server, the transactional data is processed and forwarded onto the now functional external system.

Scalability

Optimized to process transactions as efficiently as possible with limited delay, SmartConnector automatically adjusts to accommodate messages as they increase in size and/or in number of messages or sessions.

Designed for Speed

SmartConnector has the ability to process multiple transactions simultaneously while a memory resident database ensures speed of access by eliminating the need to read/write to a physical drive. The design has been optimized to accept inbound data as quickly as possible without tying up the sending system.

SmartConnector for SAP supports all SAP Modules and Components, including SAP R/3 Versions (from 3.1 through 4.7), and all releases of mySAP (ECC 5.0 and 6.0), and supports bi-directional, synchronous or asynchronous connections between SAP and SmartSolve.

Modules Supported	Functions
Sales & Distribution	Customer Master Vendor Master
Human Resources	Employee Master
Materials Management	Materials Master
Production Planning & Control	Production Reject Codes Product Work Centers Material Routing Operations
Quality Management	Quality Notifications

Key Features & Benefits

Capabilities	Benefits
Cost Effective	Maximize your existing SAP™ systems and easily utilize Pilgrim’s Enterprise Risk, Compliance and Quality Management systems to reduce risk, increase compliance and improve quality.
Built on Certified & Patented Technology	SmartConnector is built on certified SAP™ technology, assuring correct functionality.
Efficient Integration	No programming or modification needed. Drastically reduces the time to deploy over custom programmed solutions.
Low Cost & Maintenance	Because it’s configuration-based, integration is easy. Once installed, SmartConnector is seamless.
Adapts to Change	As your company grows and your needs change, SmartConnector adapts easily without any coding.
Supports all SAP™ Modules and Components	Can easily be configured to meet unique requirements for your business. Supports bi-directional, synchronous or asynchronous connections between SAP™ and Smartsolve.

Utilities

Document Extraction Utility (DEU)

Do you need the ability to view the documents stored in Pilgrim Software’s Document Management system in an off-line mode?

Pilgrim’s Document Extraction Utility (DEU™) is the answer. DEU is a utility tool that allows for the extraction of documents from Pilgrim's Document Management Repository into a defined folder for offline viewing. Documents can be extracted as, and when, required. The business use cases for such functionality are numerous. For example, if a Blood Services organization needs documents available to its users in their bloodmobile buses, DEU will allow for the extraction of appropriate data and enable the information to be put on a CD. If an organization needs its field sales team to have access to required procedures, policies, form templates, etc., without connecting back to the server, DEU will be an ideal functionality.

The extraction process is fully configurable. Users can extract documents by Document Type, Category and Repository defined. It can also be filtered by any other fields available in the document profile page. This is a one-way tool and it does not update any changes made by users to the offline documents.

If there is an updated document in the online application, the administrator can re-extract the changed document to the folders and then re-distribute the extracted folder to the users. DEU will provide an automatically generated table of contents with the relevant hyperlinks for the required users to access the documents in a user-friendly manner.

Key Features & Benefits

Capabilities	Benefits
Easy access of document viewing	Provides offline ability to view document for field technicians who do not have access to SmartSolve online.
Reduce cost of investment	Without Document Extraction Utility, the customer would have to provide access to SmartSolve to the remote users or the user would have to manually extract required documents for offline viewing.
Extraction is configurable	Users can extract and view only the required document for their needs with no need to extract the entire document repository. The Administrator has ability to configure the filter by any fields available in the metadata search, including Document Type, Category and the Document Repository defined.
HTML Pages for listing of the offline documents	Using the HTML page, the user can easily view listing and search of document with Document Number, Document Title, Effective Date, Expiry Date, etc.
Hyperlink on the document in the HTML page	Hyperlink eliminates the folder navigation process and the user can directory launch the document in the appropriate application.

External Data Source Lookup Utility

Recognizing that integration to the third-party or homegrown systems is required to make any good process or system work, Pilgrim has devised various integration utilities. One such utility tool is External Data Source connector. This utility tool allows the customer to easily create, within the Pilgrim solution, the required queries to a specific database/system that will display the required columns of the third-party system data and the rules on which columns to return to the Pilgrim application’s data entry page. Using this powerful yet simple utility tool decreases the cost of integration significantly, while providing for the ability to interact with the third-party systems data in real-time.

External Data Source is part of the SmartSolve forms management framework that supports end-user defined data sources for look-up and drop-down value selection. With Electronic Data Sources you can:

Retrieve data from another database
Retrieve data from your SmartSolve database on your network
Retrieve data from another application through a web service call

The External Data Sources Utility allows users to configure fields in SmartSolve to zoom to or display information from a data source outside the application. This allows an administrator to link external data, which may be managed in a third-party application, to a SmartSolve field within a form (record). Then an end user can select this data and attach it to the SmartSolve record.

To use external data sources, you must:

Define the ODBC System Data Source Name (DSN) on the SmartSolve server.
Define the external data source in the SmartSolve application.

Web Services

Integration Web-Services Kit

SmartSolve^® Integration Web Services Kit^™ is a software platform that provides the connectivity between third-party applications and SmartSolve. The kit includes prebuilt web-services to synchronize your organization’s key system information, complaints and nonconformance events captured in the other systems such as ERP, SPC and CRM systems. The pre-built Web Services Kit will allow you to leverage:

Existing master data, including employees, customers, vendors, contacts, parts, operations and their associated costs and failures, from your existing ERP, CRM or other system, to SmartSolve
The customer complaints data from existing CRM systems to SmartSolve
Nonconformance events, such as ERP systems for shipping/receiving nonconformances or SPC/LIMS systems for out-of-tolerance/specification to SmartSolve
Events Synchronization - including support for customer, product, process, and general exceptions, or any other type of event
Document Profile Information Synchronization - including support for critical document-related information such as attributes, types, categories, certifications, and references to the source documents between SmartSolve and third-party content management systems
Electronic Medical Device Reporting (eMDR) communication through customer’s E2B gateway for eMDR submissions and return of FDA acknowledgements
XML data extraction of any SmartSolve objects for import/update in third-party systems

The Web Services Kit provides sample XML files and documentation on how to use the web services to integrate with SmartSolve.

The Web Services Kit comprises:

The WSDL file which defines the SmartSolve Web Services’ exposed web methods
Sample Input XML files to synchronize master data, complaints and nonconformance events
Test application to invoke the SmartSolve web services
Application notes describing the test application

SmartSolve Integration Web Services are based upon Microsoft .NET and provide secure access to the SmartSolve platform. External applications and systems can be integrated easily with SmartSolve to enable data exchange or add-on products.

Push and pull issues and associated data from other external applications from/to SmartSolve
Secure web services communication using HTTPS
Sample application provided to demonstrate SmartSolve Integration Web Services authentication and web method invocation SSIWSK-0210

Benefits of Web Services

Based on industry open standard formats – XML and SOAP
Seamless integration between various ERP and CRM systems with SmartSolve
Allows transfer of data captured in existing systems (ERP, MES, CRM, Complaints, CMS, etc.) without manual intervention, thus ensuring data accuracy
Reduces non-value-added costs such as the cost of re-entering data to SmartSolve
Reduces the probability of human errors in reentering data into SmartSolve
Allows for cross-platform integration where the source system can be any system capable of calling web services; systems do not need to be in a Microsoft .Net platform
Detailed knowledge of systems behind firewalls is not needed, making it simpler to create system connections