Compliance |
Is PharmaReady Compliant with 21 CFR & Part 11 requirements?
Yes |
General |
Can PharmaReady integrate directly with SharePoint Portal Server?
Yes |
Authentication |
Do you have Active Directory or LDAP integration for users and groups?
Users can be imported into PharmaReady for initially setting up users or AD can be used to authenticate users with a single login/password combination.
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In general, how long does it take for a client to validate your system?
Typically one to two weeks including customizing the IQ and OQ documentation as needed.
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Do you provide any validation documents (IQ, OQ, PQ) to jumpstart a client’s validation effort?
Yes IQ and OQ are provided. TAKE Solutions' Onsphere is available to assist with additional validation services upon request.
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Servers |
What is your method for determining server and disk space requirements?
50 Gigabytes of storage plus 2 times the projected document/file storage needs. |
Reporting |
Can you list documents based on metadata?
Yes
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Do you have Workflow reports?
Yes
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Are your reports customizable?
Yes, using SQL Reporting Services.
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Can you report on administrative documents by group, etc.?
Yes, using the data summary function.
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Can you report on metrics on workflow - find process (in)efficiencies, bottlenecks?
Yes, using the Due Date review report
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Can you run current activity reports by user, team, program, site?
Yes |
Security |
Personal document rights management
Yes
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Can you view user & group permissions on a document?
Yes
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Please explain how you define rights on a folder and do sub-folders and files inherit them?
You define user access to a library, to a group, or to a document, not to folders. |
How are user profiles/roles/groups managed?
You can manually manage them or use Active Directory.
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Can we define permissions by group?
Yes
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Does PharmaReady Integrate with active directory security groups?
Yes
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How do you meet the authentication methodology Part 11 compliance?
A unique ID and password combination required.
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Is the system usable via vpn? Is source IP address recorded?
Yes |
E-Signatures |
Are electronic signatures available?
Yes, and you do not need a third party tool
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Do you require the user to provide a reason for signature?
Yes, E-signature meanings are created during setup process.
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Are multiple e-signatures per document supported?
E-signatures can be applied for check-in, changing metadata. Approving and publishing a document.
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Can we roll back a signature (and document the reason)? If so, what is the impact on workflow?
Yes, but it must be before publishing, You can check the doc out, make changes and check back in and the e-signatures are reset.
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Can we sign a document at multiple steps of its lifecycle?
Yes, E-signatures can be applied for check-in, changing metadata, approving and publishing a document.
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Metadata |
Can we define minimum sets of metadata per document type? Does this require additional customization / intervention on your part?
Yes, Can create custom fields for libraries, categories or the entire system
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Can we have multiple versions of metadata for a particular doc type? Can newly mandated metadata be applied to existing documents? Is there an audit trail behind this act?
Yes
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Can you add comments to a document?
Yes
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Can we associate one document to more than one category of metadata? i.e. one document may be in multiple categories, Date changed, etc.
One document may be in multiple folders, but not multiple categories.
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Is the status of document shown visually (draft, final, etc.)?
Yes but, only published documents are shown to end users. |
Workflow |
Are there template management features including versioning and archiving. Will a new version of a template automatically be associated with existing workflow?
You can upload templates into PharmaReady. A template can be associated to a library or category.
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Workflow may begin with a Template?
Yes
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Can you associate metadata with templates, e.g. list templates by group, etc.?
Yes, templates can be associated to a Library or Category.
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Do you have the ability to turn a document into a template?
Yes.
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Will we have the ability to import documents created outside of the system?
Yes
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Can you Automate and customize schemes for document numbering?
Yes
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Must provide the ability to copy a document?
Yes
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Does PharmaReady Preserve original templates upon “new doc” activity. i.e. default action doesn’t edit a template, it creates a new doc based on that template?
Yes
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Do PharmaReady have Ad hoc workflow, i.e. routing a document for review outside of a pre-defined workflow?
Yes
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Is the workflow process owner id’d in system as distinct from person who initiated workflow?
Yes
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Do you have auditable reason (customizable rules) entered for checking out a document within or outside of a workflow?
There is a comment field is located on the Check-in page.
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What is your distinction between reading a document and checking a document out?
Only Authorized users can check out a document and edit the content. Reading a document is opening a read-only document.
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Will we have ability to route documents for review and/or approval.
Yes
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Do you have graphic visualization of workflow?
Yes, Icons appear on Central or Work with Docs page.
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Do you have an intuitive interface?
Yes
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What imaging software is supported or required?
We support most file formats including PDF, TIFF, JPEG, etc. from most imaging software |
Audit Trails |
Are audit trails show per document history?
Yes
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What information is collected to maintain Part 11 compliance?
All information regarding the document.
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Does system support usage in multiple time zones? Does the system base time on a central location?
Yes
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Is the audit trail available both online and via a clean printout?
Yes
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No modifications can be made to the document without check-out?
Yes
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Do you have customizable comments management for audit trails, predefined lists of reasons or forced free-text descriptions?
We have predefined meanings for e-signatures |
Search |
Will I have the ability to search by custom attributes?
Yes
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Can I do a scope search by metadata criteria?
Yes
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Are there document pre-views in search results with a couple of lines of content?
There is a list of matched documents that appears.
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Does system support full-text search of file content? If so, what file types?
Yes, any file type. |
Publishing |
Can the system generate eCTD compliant submissions? How is an eCTD and its 200 folders handled? Any template for folder structure?
Our fully integrated PharmaReady eCTD module is scheduled to release in Quarter 1 2007 with V4.0.
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Can you batch-export to file system?
Yes
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Does system support virtual documents?
Yes
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Can electronic signature signoff be linked to a virtual document?
Yes
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Is it possible to define a folder template containing subdirectories of templates?
Yes
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Do you have the ability to directly convert to pdf within the system?
Yes |
Integration |
Is PharmaReady based on SharePoint or does it integrate with Sharepoint?
Yes
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Does PharmaReady have an e-SOP module?
Yes, Training Record Management System
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Does PharmaReady integrate with the Microsoft Office Suite?
Yes
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Does PharmaReady integrate with Microsoft Exchange or Outlook?
Yes. PharmaReady works with any SMTP compliant email system. PharmaReady relays email via the
SMTP server. |
Usability |
Can a document “live” in multiple document libraries through views, etc.?
A document can be in multiple folders with the same library
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Are there any restrictions on document types (.sas, .doc, .xls, .ppt, .pdf, images, etc.)?
No
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Training & Support |
What is your approach for training business users?
We have a 4-course training curriculum that we deliver which is included in the initial software license fee.
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What is your approach for training system administrators?
Training for system administrator is two-fold. We will work with them during the initial setup phase of the system to help get the application setup to best fit the needs of our customer’s organization. We also have a one day formal training class for administrators.
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Is training at your company’s training facilities or at the client site? If not at the client site, where are your training facilities located?
If not at the client site, where are your training facilities located? We conduct training at the customer locations and/or via web-based training.
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What is your company’s strategy for product updates and new major and minor releases?
TAKE Solutions' Onsphere anticipates major releases to the PharmaReady product every 12-18 months with minor releases every 6 months.
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How and when are known software problems (e.g. bugs, errors) resolved? Do you publish a list of known problems and workarounds?
We have a support website http://support.pharmaready.com where we publish FAQs, known problems, limitations, work- arounds, etc.
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How are problem fixes/patches distributed to clients and implemented?
Via email, ftp and/or CD.
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What skill sets are required to support your software?
Technology savvy document/QA manager is the best skill set.
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Explain if, or how, the user group influences the priority of system modifications and enhancements.
We get detailed feedback from all existing customers and formal evaluators of the product and use that info as key guidance for the next release of the product. |
Versioning |
Do you have customizable version numbering?
Yes
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How are multiple versions of a document handled? E.g. final Word doc is published into a pdf. Are these two documents or multiple versions of the same doc?
Users see pdf document, author can see both
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Will we have the ability to version documents using both major versions (i.e. 1.0, 2.0, etc) and minor versions (i.e. 1.1, 1.2, 1.3, etc)?
Yes |
Archiving |
Will PharmaReady generate reminders (reports) when approaching archival / expiration of a retention period?
Yes
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Will PharmaReady inventory & manage archived media?
You can view a report of archived documents
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We must be able to define retention policies by flexible criteria, e.g. country and/or document type. This should be defined either at the template or document level.
Yes |
Administration |
Does PharmaReady list users and their group membership
Yes
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Can you list groups and their users?
Yes |
Platform Architecture |
Is the platform web-based? If so which technology is the platform based on i.e. .NET
Yes, Asp.net
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Is the system client-server based?
It is fully web based
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Do you provide client based tools i.e. batch import/upload etc..
Yes
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Describe the system documentation?
User guide, tutorials, and online help
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Describe the software development methodology used to develop the system.
We have SOPs to document our SDLC processes.
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Has the system been fully validated? To what standard(s)?
Yes, According to our defined SOP's
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What network protocols are supported?
All user and admin functions are fully web based and require stand HTTP protocol.
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What are the network WAN/LAN configurations and capacity requirements?
PharmaReady uses standard HTTP over IP so that is the only requirement. Capacity is dependant on the number of concurrent users and type and size of the documents. |
Company Specific |
How many years has your company been in business?
18 years
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What is the average time required to deploy a system?
Two weeks
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Do you have the capacities to build custom modules and reports?
Yes
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Do you offer different versions of your application based on the clients needs i.e. modular, lite versions etc.?
Yes
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Do you have experience working with companies in the life-sciences?
Yes, extensive
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Have you undergone any audits for regulatory compliance or systems validation?
Yes. In the last FDA level audit, we received NO Critical or Major findings.
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Do you provide any other services?
Yes. Clinical Data Management Services, Microsoft .NET application development; staff recruiting; integration and consulting services, including Microsoft Sharepoint development and implementation. Additionally, we can provide optional validation services. We can also host the client's PharmaReady Solution in our datacenter, and extend the client's Active Directory functionality to the document management system.
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What form of ownership exists for your company?
TAKE Solutions is a Corporation |
