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As an optional service, CPFS can print and bind a hard copy of the TOP. In addition, critical, original signature documents can be collected as part of the service offering and integrated as part of the delivered TOP; along with duplicate digital copies archived as part of the web based TOP delivery.
Yes, CPFS can be leveraged to perform Installation Qualification. As you may be aware, the ASTM E2500 standard is written to allow for this leveraging. Good Engineering Practices (GEP), as it relates to ASTM E2500, and the idea of being able to leverage activities into a usable IQ requires extensive audits of each and every vendor; along with a plan to augment any perceived deficiencies identified per vendor. This activity becomes a management issue throughout the project for the client. Based on CPFS’s management of work-flow processes and consistent measuring of performance for all contributors, enables CPFS to be leveraged as an effective part of the IQ process and creates a standard GEP for all. This effort must be integrated to be identified in the clients validation master plan and CPFS must be trained as a trainer such to manage all contributors and ensure leveraging is achieved.
All users will be required to utilize the same work-flow and inspection criteria; as defined by the client. This work-flow is managed through a common web based interface and activities are reported to ensure compliance with accepted deliveries. CPFS is in constant audit of information and actively corrects deviations or assists users with resolving compliance issues.
CPFS provides value to small projects too; for example an OEM equipment with as little as 20 tagged items. This type of project often leads to multiple small projects and can be the beginning of converging a facility document archive to an electronic searchable archive.
CPFS will manage the entire TOP delivery from start to finish. Staff will be available 24/7/365 via technical phone support. Additional support to a project is determined at the proposal stage of a project and often leads to project kick-off support. Kick-off support may require a project liaison to be on-site for a predetermined duration to ensure communication is received first hand.
CPFS is agnostic to any other software and is built on an open architecture. CPFS can map or link data to almost any business system software.
Each and every document is captured upon upload, User ID logged, and date stamped. Any new documents will archive the old and any new user information is archived in the same manor. No document or data input is ever discarded.
The CPFS founders have over 25 years of experience in their respectful fields. Rick Kramer, as an engineer and project manager, has developed and delivered TOPs to BioTech clients in a similar fashion for a prior company. Lynn Donnell has developed and run software companies that provide web-based systems for information management in the banking and US Defense industries.
The optimum time to stop a house from burning is before it starts or at the first sight of a flame. However there is also great value in stopping the fire at later stages. The same is true with CPFS services. Clients ask us to offer services at the beginning of a project but also ask us to index and store information for completed projects. Once information handling deficiencies are found it is best to correct them ASAP and, if possible, design deficiencies out of future projects. Employing CPFS early in the project brings the best total value to your project. The optimal point to employ CPFS services is traditionally at the end of conceptual design or as you begin basic design of your project. However, CPFS can perform many of the tasks at any point of the project and would consider the following milestone points of beginnings:
- Start of basic design
- Point of procurement of long lead items
- Receipt of paper TOPs
- Completion of IQ (paper conversion to electronic)
- Legacy system conversion (paper to electronic) or (electronic to indexed electronic)
The only point in which CPFS doesn’t provide value is if project documents have already been imported into an electronic searchable repository of information. At any other point a CPFS Representative can discuss the value gained by utilizing our services.
CPFS delivers an electronic TOP that is searchable and has customizable view ports for each user to define the order in which to view the documents. This is a single repository of original, as installed information. CPFS will also data map this information to a client’s defined facility business system software and/or provide a tabulated and bound hard paper copy.
CPFS will provide work-flow adjustments and assignments that match the project execution strategy. Further customizations will be considered under advisement and integrated based on priority of need and desire for wide spread non-specific client use.
The main offering of CPFS is to deliver a qualified electronic TOP for your project with easy integration to your facility business systems. However, CPFS recognizes the ease of use of our deliverable and can offer continued web access of your information on an annual contract basis. This can also include change control management and continued archiving of information.
CPFS reporting metrics can provide project management indicators on missing data, slow incoming data, and the number of welds performed or to be performed. CPFS can also provide consolidated project level report on component deliveries and schedule impact potentials.
Any deviation is reported by CPFS staff and attempted to be resolved. If determined unresolved, CPFS will research deviation for root cause and elevate issue to appropriate specification owner for further dissemination. The outcome will provide a report to update the original specification or be the description of deviation acceptance to be filed as a report.
To manage risk, CPFS provides status reports, score cards, and deviation and resolve reports. These reports include status on CPFS activities as well as client-performed activities. In order to avoid risks, re-work and unneeded deviation reports, CPFS strives to complete tasks as they occur.
CPFS will partner with imaging processors to convert your paper documents to electronic file format. Indexing, file naming, and searchable key attachments are done by CPFS to deliver a similar product as if you utilized CPFS throughout the duration of the project. Further services can be employed to determine missing data and deviation resolve or reporting.
Vendors (contributors) are encouraged by CPFS advancements in TOP collection methods. The predefined placeholders, ability to see and understand specific document requirements, and the ability to report missing data is a benefit to the supplier. In addition, CPFS facilitates an archival location for documents and aids the supplier in managing the TOP process requirement that is not their core competency. Vendors easily cooperate with CPFS because the pre-determined placeholders and definitions of requirements allow suppliers to complete their projects faster, more accurately and ultimately get final payment sooner.
CPFS technical staff is in constant audit of key attributes of your current issued specifications as it relates to data sheet information and the actual received assets. Additional DQ effort is performed as a third party review to ensure received asset has the capability of performance specified.
CPFS is not providing engineering services, only a third party review and opinion of assets meeting what is specified.
CPFS can integrate any level or detail number of documents into the service. CPFS can assist with developing and structuring a total list of deliverable documents for all phases of a project.
Missing data reports can be generated on a daily basis; however it is recommended to generate weekly reports to ensure the management of information and deviations are being performed expeditiously.
CPFS provides a listing of document placeholders assigned to each vendor (contributor) and attached to each placeholder is an anticipated document receipt date. This information provides the metrics used to report on the performance of a particular contributor or as a whole project status.
Like performance status reports, CPFS can also report on a specific vendor as it relates to on-time performance and accuracy to requirements in the form of a scorecard.
Only authorized users have permission to access information. Authorized users are issued a unique Username and ID; which requires an electronic signature capture as well as the User ID# generated by the authorized user. User identification is related to an active, verified email address. Email addresses are verified and approved for use on the project by the client and CPFS. Once information is loaded into CPFS’s secure website, it is non changeable, secured and archived.
Authorized users are issued a unique Username and ID#; which requires an electronic signature capture as well as the User ID# generated by the authorized user. User identification is related to an active, verified email address. Email addresses are verified and approved for use on the project by the client and CPFS.
CPFS will configure communication protocols specific to project needs and provide training for users as they become contributing team members; specific to their usage and need. An intuitive interface is used to access information; however to leverage any level of Installation Qualification (IQ), CPFS is trained as a trainer and will carry forward training records of all project users. Base training for CPFS staff members is cGMP and GDP plus specific client required training related to requirement of performance.
CPFS offers 24/7/365 phone support. On-site support is available for contracted support fees or on an as-needed basis. To improve immediacy and consistency, CPFS employees staff in strategic locations to assist in any onsite support requirements.
As part of CPFS’s initial set up of your project, we provide each user a web based training program which is documented in a project training log and must be completed by each user to receive login access.
CPFS encourages client involvement. It has been our experience that our clients already outsource many of the activity services offered by CPFS. Furthermore, it is our main focus to be experts in evaluating information and resolving deviations and dedicated to employing experienced staff (experts in this field), who are trained and dedicated to this service. CPFS fully integrates a final approval process of information delivered and is willing to integrate client staff within any point of the total work-flow management process.
Multiple users can view a common document simultaneously. However the user assigned to satisfying that particular placeholder document is the only one allowed to archive a new document prior to the approval of that document.
CPFS will allow access to client approved vendor users and provide appropriate training as required by the project execution strategy. CPFS will provide onsite assistance to clients or vendors as required.
All information is securely stored on CPFS servers and hard drive space, which can be hosted at a location of your choice; our remote hosting site or your internal server room. CPFS offers services and access via the Internet.
Dependent on your server location choice, CPFS remote server services include automatic back up protocols and disaster recovery activities. Data and information stored on local CPFS servers are automatically backed up daily and off site vaulted. The CPFS server location is dependent on your organization’s internal policies and procedures.
No software investment is required. CPFS offers access to information via an Internet browser along with a compatible Java Runtime Environment (JRE).
No hardware investment is required. Use and access to information is provided from any hardware device that is equipped with an Internet browser and compatible JRE.
Contact Us to discover how CPFS can apply our distinctive process to your company’s most advanced project information management challenges.