BE 491 Documentation

documentation

types of ________________:

Graphic Media

Text Media

Numerical Media

Visual Media

Lab Notebooks

Engineering Reports

Photo

Engineering Drawing Cases

Raw Data

Hard Copy

Electronic Copy

Microfilm

commercial

Whenever you develop a device for ____________ use, you MUST KEEP DETAILED RECORDS of every step in the process

change

Including documenting every __________ in the development of a product. Before and after marketing approval

Life Cycle

These records MUST be maintained for the entire _______ __________ of the Product

concept phase documentation

Some Activities:

• Define market need

• Competitive Research

• IP Research

• Initial Regulatory Path

• Define Need Specifications

• Define Product Specifications

document

manufacturing-quality assurance: ____________ all inspection and test plans

document

manufacturing-quality assurance: ____________ all quality audits of suppliers and sub-suppliers

7

manufacturing-quality assurance: Maintain adequate quality records for a minimum of ______ years or as required by contract or customer

contract

manufacturing-quality assurance: Document all inspections done throughout the life of the ____________

corrective actions

manufacturing-quality assurance: Document all _____________ __________ taken and follow-up procedures implemented

overstate

marketing: Document all the material about your medical device that you make available to outside entities and confirm that it does not __________ the claims and indications of your approval

available

marketing: Document the opportunities you have had to make material ____________ (including a website)

material

marketing: Document any changes you have had to make to the marketing _____________

orders

commercial use: Document all the __________ you have received for your device and that the purchasing entity qualifies to purchase your device

shipment

commercial use: Document the ____________ of all goods related to your device

return goods

commercial use: Have in place a __________ ___________ Authorization procedure and document all returned goods

adverse

commercial use: Track all device usage and record and report any __________ events

discontinue

obsolescence: notify all users of plans to ______________ product

support

obsolescence: Continue ____________ for all products currently in use

Materials

obsolescence: Have a ____________ Redistribution/Disposal plan/process

tracking

obsolescence: Continue ___________ all device usage and record/report any adverse events

close out

obsolescence: have product ________-________ plan

store, catalog, control

archiving: how do you _________, ___________, and __________ all of this documentation?

nonclinical

In the 1970s, FDA inspections of ___________ labs revealed that some studies submitted in support of the safety of regulated products had not been conducted in accordance with acceptable practices.

GLP Regulations

On December 22, 1978, the FDA propagated ________ ________________, 21 CFR (Code of Federal Regulations) Part 58. The regulations became effective in June 1979

GLP regulations

establish standards for the organization, process and conditions under which nonclinical laboratory studies are planned, performed, monitored, recorded and reported and are intended to assure the quality and integrity of safety data submitted to the FDA

GLPs

designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies.

Good Clinical Practice (GCPs)

International ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve participation of human subjects

Good Manufacturing Practices (GMPs)

Part of quality assurance to ensure that products are consistently produced and controlled to the quality standard appropriate to their intended use and as required by the marketing approval

resources

GLP key concepts:

Facility

Personnel: Study Director, Quality Assurance Unit, Testing Facility Management

characterization

GLP key concepts:

Test article- any food or color additive, drug, biological product, electronic product, or medical device for human use.

Test system- any animal, plant, or microorganism to which the test or control article is administered or added for study.

rules

GLP key concepts: Standard Operating Procedures (SOPs)

results

GLP key concepts:

Data

Reports

Quality

GLP key concepts: __________ Assurance

test article

any food or color additive, drug, biological product, electronic product, or medical device for human use

test system

any animal, plant, or microorganism to which the test or control article is administered or added for study

Study Director

Testing facility management roles: Designate a _________ _____________ before the study is initiated

quality assurance unit

Testing facility management roles: Assure there is a...

scheduled

Testing facility management roles: Assure that personnel, resources, facilities, equipment, materials and methodologies are available as _____________

deviations

Testing facility management roles: Assure that any _____________ from these regulations reported by the QAU are communicated to the Study Director and corrective actions are taken and documented

quality assurance unit

what does QAU stand for

study director

For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the ________ ____________

study director

has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control.

study director

signature on the protocol legally binds him/her to conduct study procedures as outlined in the protocol and according to the GLPs

study director

who assures: The protocol, including any change, is approved and followed

study director

who assures: All experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.

study director

who assures: Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented

study director

who assures: Test systems are as specified in the protocol

study director

who assures: All applicable GLP regulations are followed

study director

who assures: All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study

QAU

A testing facility shall have a ________ which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records and controls are in conformance with the GLPs

QAU

shall be entirely separate from and independent of the personnel engaged in the direction and conducting of that study

QAU

who assures: Inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study

QAU

who assures: Prepare and sign a statement to be included with the final study report

QAU

who assures: Review the final study report

QAU

who assures: Determine that no deviations from approved protocols or SOPs were made without proper authorization and documentation

SOPs

shall be established for all activities

SOPs

Each laboratory area shall have immediately available laboratory manuals and _______ relative to the laboratory procedures being performed

historical

A ___________ file of SOPs and all revisions, including the dates of revisions, shall be maintained

Study Director

The study shall be conducted in accordance with the protocol.

SOP signed and dated by __________ ____________

compliance

The study, including test articles, shall be monitored for _______________ with the protocol. Good Documentation Practices

attributable

the raw data can be traced by initials or signature to the individual observing and recording the data

legible

the raw data are readable and recorded in a permanent medium

contemporaneous

the raw data are recorded at the time of the observation

original

the first recording of the data.

accurate

the raw data are true and complete observations

raw data

any laboratory worksheets, records, memos, notes, or exact copies that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study

raw data

may include photographs, microfilm, computer printouts, magnetic media, including dictated observations and recorded data from automated instruments

QAU

❖ The report is also signed and dated other scientists/ professionals involved in the study.

❖ The statement prepared and signed by the _______.

study director

Corrections or additions to a final report shall be in the form of an amendment by the ________ ___________

The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition and shall be signed and dated by the person responsible

retained

All raw data, documentation, protocols, final reports and specimens (except wet specimens of blood, urine, feces and biological fluids) shall be _____________

archives

There shall be ___________ for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens and interim and final reports

deterioration

Conditions of storage shall minimize _______________ of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens