PONEMAH PHYSIOLOGY PLATFORM
GLP
Validation Support Package
- Test Plans
- Vendor Audit
- Upgrade Assistance/Change History
- On-Site Validation Assistance
- Data Security Option
Whether you are validating the PONEMAH Physiology Platform for the first time or revalidating
due to a version upgrade, the Validation Support Package can assist every GLP
user's needs in order to comply with 21 CFR Part 11 requirements for computer system
validation. DSI recognizes that computer system validation is a time-consuming task,
and therefore, is providing the Validation Support Package to assist its customers with
validating the PONEMAH software and DSIPONEMAH hardware interfaces in order
to ease the validation process.
The Validation Support Package is designed to assist with the Installation Qualification
(IQ) and Operational Qualification (OQ) phases of the user's validation endeavors.
Test documentation and design specifications are provided, as well as other supporting
features to assist with reducing the amount of time spent on validation activities and
helping the user to culminate a well-rounded validation plan.
Validation Documentation
The Validation Support Package is designed to assist
the GLP User with the Installation Qualification (IQ) and
Operational Qualification (OQ) phases of their
Validation Plan. Test plans will assist with validating
the installation and functionality testing of the
PONEMAH software within the User's computing
environment; procedures for running the program
under known conditions with defined inputs that can
be compared to pre-defined expectations that are
provided. In addition, test conditions will include not
only "normal" or "expected" values, but also
stress/limit conditions, where applicable.
Vendor Audit
FDA regulations state that the User should qualify
the vendor to ensure the quality of the product; the
User should perform an audit to evaluate the vendor's
software development activities and product quality.
The PONEMAH design and development team
welcomes its users to perform a vendor assessment. Please contact DSI Customer Service to request additional information regarding On-Site Audits or to coordinate completion of Vendor Audit Questionnaires.
Upgrade Assistance/Change History
A change history summary will be provided
indicating changes performed with each new version
of the software. This will assist the customer with
deciding to what extent they need to perform revalidation
of the PONEMAH software when the user
upgrades to a newer version. |
Test Plan Features
- The test plans contain the same procedures used
by the PONEMAH design and development team
to validate the PONEMAH software.
- The test plans will save the User a considerable
amount of time in creating these documents.
- The test plans list a set of validation objectives to
test the functionality of the PONEMAH
software; these objectives are traced to the
software's requirements defined in the Design
Specifications.
- The test plans detail step-by-step procedures for
validating the PONEMAH software, as well as
PASS/FAIL criteria with a list of expected results.
The expected results are both qualitative and
quantitative.
- The test plans are provided in Microsoft Word
format; therefore, can be easily edited, if
needed, by the User.
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Package Options
Escrow Agreement – The User will be listed as a
beneficiary on the software escrow account established for PONEMAH software in order to
protect the User's intellectual property investment and provide insurance of the usability of the User's
software and technology investment. For more
information regarding the Escrow Agreement, refer
to DSI | PONEMAH Bulletin 446-78.
On-Site Assistance - DSI is available to aid with validation of the PONEMAH software by offering assistance at the customer's facility. DSI can support the user with Validation Planning, as well as provide assistance to customize test plans to meet the customer's specified validation needs. On-site assistance is most helpful for users performing validation of the PONEMAH software for the first time. Please contact your DSI Technical Sales Representative to request additional information regarding On-Site Assistance, including pricing.
Validation Support Package Test Plans |
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P3 Plus Core Modules
Data Manager
Data Reduction
Data Scheduler
Data Security Option
Data Storage Scheduler
Data Review
ECG Pro (Template)
Inductive Plethysmography (RIP)
Jacketed External Telemetry,
Jacketed External Telemetry with Respiratory
Study Protocol Option
Summary
Video
Acquisition Interfaces
• ACQ-16
• ACQ-7700
• 12 Lead ECG Amplifiers
• Dataquest™ OpenART™ |
Analysis Modules
Blood Pressure
Cardiac Volume
Coronary Blood Flow
Cystometry
Electromyogram
Electrocardiogram (Rate Only)
Electrocardiogram (Single and Multiple Lead)
Indirect Blood Pressure and Indirect Blood
Left Ventricular Pressure
Monophasic Action Potential
Pressure Sound
Pulmonary Air Flow
Pulmonary Compliance and Resistance
Pulsatile Tissue and Gut Motility
Respiration for Blood Pressure
Systemic Blood Flow
Unrestrained Plethysmography |
Equipment Calibration for GLP Studies
FDA Regulation 21CFR Part 58.63 requires that laboratories conduct routine maintenance and calibration of equipment used for GLP studies; maintenance and calibration or equipment must be conducted according to a set schedule. DSI recommends that Standard Operation Procedures (SOPs) include requirements for annual calibration of DSI | Ponemah hardware in order to comply with GLP regulations and ensure integrity of GLP data. For more information regarding DSI Hardware calibration services, please see DSI | Ponemah Bulletin 446-84F.
NOTE: As new versions of PONEMAH software are released, new modules may be added. This list may not include all current
features of the P3 software that can be validated per the Validation Support Package. |
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DSI | PONEMAH products are not intended for the purposes of diagnosis of disease or other conditions,
or in the cure, mitigation, treatment, or prevention of disease, or used as a life support device. Use of DSI
| PONEMAH products are solely for the purposes of conducting life science research.
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*Good Laboratory Practices, Section 58.63 Maintenance and Calibration of Equipment [43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept.
4, 1987; 67 FR 9585, Mar. 4, 2002].
Section 58.63(a) "Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or
assessment of data shall be adequately tested, calibrated and/or standardized.
Section 58.63(b) "The written standard operating procedures required under 58.81(b)(11) shall set forth in sufficient detail the methods, materials, and
schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment...".
