Use with EDM Systems

VPM can be used in conjunction with Electronic Document Management Systems, such as Documentum or Qumas.  If you’d like to discuss how our customers do this, please contact us.

Knowledge Capture and Management

Most organizations today fail to effectively capture, manage and leverage their own internal knowledge. Frequently, corporate knowledge is either trapped within individual employees’ systems or lost when employees leave the organization.

VPM helps your organization share, control, and manage your knowledge using powerful tools not found in traditional "groupware" or workgroup collaboration software. VPM’s unique knowledge structuring and "chunking" technology makes it possible for you to share the important reusable knowledge and discard or ignore the information you don’t want to keep.

Each time a VPM user creates a protocol, that protocol contains knowledge that others within your organization could potentially use for future protocols. By centralizing all of the protocols you build in one database, everyone within your organization can share knowledge.

Link to Specifications (via ESM)

One of the most difficult problems facing validation personnel worldwide is the issue of the ever-changing specification. Although validation documents are supposed to be based on specifications, frequently this does not occur. Sometimes specifications do not exist or they are difficult to locate or, more often, they are available, but not up-to-date. Regardless, protocols must be generated.

Frequently, protocols are generated from old or erroneous specification data. The result: erroneous protocols that either fail their acceptance criteria or produce deviations or discrepancies that must, in turn, be explained. These problems result in increased cost and time.

VPM has solved this problem by dynamically linking protocol documents to the specification data they are based upon. No longer must a validation person track down the most up-to-date specification for a piece of equipment or a process, because the protocol is automatically linked to the correct data. The specification data is stored in the ESM database, which can contain all GMP specification data for a system, a building or a facility.

Protocols can be updated with the most recent specification data, thus eliminating errors produced when protocols refer to inaccurate specification data.

This revolutionary feature is available to users who have purchased both the ESM and VPM modules.

Part 11 Compliance

VPM is compliant with 21 CFR Part 11.

Rapid Protocol Development

Develop a 100-page, complete standardized protocol in under five minutes? Impossible? Not when you use VPM!

Protocol development has traditionally been done either "from scratch" or by "cutting and pasting" text from old legacy protocols. These techniques are time-consuming, expensive and wasteful of precious Engineering or Validation resources. The VPM module utilizes a Microsoft style Wizard to automate the protocol development process.

Security

Any attempt to standardize a process will fail if appropriate security controls are not available to protect the standards. VPM applies user-level security to determine which documents within the database a user can access. Each user is assigned a unique User Name and Password and security level.

Typically, most users should be able to change only those documents within the database that they own or author. The corporate standards, for example, are rarely made accessible to anyone without the highest security authorization.

While security is critical, flexibility and knowledge sharing are an important aspect of the VPM system. Users can take advantage of the knowledge contained within the entire VPM database by using the simple drag-and-drop interface.

Standardization

Standardization reduces cost. By standardizing the process of authoring validation documents and specifications, the costs of document preparation, review, training and maintenance are reduced. VPM uses templates, guidelines and wizards to apply standardized documentation and testing methodologies to the development of structured documents. While we utilize technology to help, we don’t force you to use anything that takes you far from your standard Microsoft Word environment.

VPM uses guidelines to help you standardize your validation program. VPM Guidelines are Microsoft Word documents that help apply standardized testing methodologies to the development of validation protocols. Each VPM guideline is an educational/training tool that is associated with a collection of recommended IQ, OQ and PQ test procedures. VPM’s protocol generation wizard uses the guidelines to generate standardized protocols in minutes.

VPM guidelines can be purchased from cGMP Systems or you can use your existing methodologies to create your own guidelines.

Web Deployment

The VPM application has two components: VPM-Admin, for managing the knowledge base of standards; and VPM-Web, for assembling protocols from the standards.

VPM-Web is a simplified form of the protocol-assembly wizard, requiring only a browser on the user’s PC to access it over your intranet. Its purpose is to help administrators to enforce standards by enabling globally distributed users to access the standards in the VPM database with minimal (one hour) training.