PDXpert software complies with U.S. Federal Drug
Administration regulation 21 CFR Part 820 - Quality System Regulation (1
April 2003). Relevant extracts are shown; refer to the actual regulation for
complete information.
| FDA requirement |
PDXpert PLM software |
| §820.20 ...Each manufacturer shall establish quality
system procedures and instructions. |
Create and manage procedures and instructions using PDXpert document
types, revision management and change workflow. A separate
QSR-related change form can reflect the unique approval requirements
of your quality documents. |
| §820.25(b) Training. ... Training shall be
documented. |
Training documents can be created and managed using PDXpert
document types, revision management and change workflow. |
| §820.30(b) Design and development planning. Each
manufacturer shall establish and maintain plans that ... shall be
reviewed, updated, and approved as design and development evolves. |
Design and development plans, like other documents, can be
managed through the revision control, review and release process
provided by PDXpert change workflow. |
| §820.30(c) Design input. ... The design input
requirements shall be documented and shall be reviewed and approved
by a designated individual(s). ... |
Requirement documents are approved using a flexible change
workflow that ensures proper review and approval by an authorized
representative of each requirement function. |
| §820.30(d) Design output. ... Design output
shall be documented, reviewed, and approved before release.
The approval, including the date and signature of the
individual(s) approving the output, shall be documented. |
Design documents are approved using a flexible change workflow
that ensures proper review and approval by an authorized
representative of each design function. |
| §820.30(e) Design review. ... The results of a design review, including identification
of the design, the date, and the individual(s) performing
the review, shall be documented in the design history
file (the DHF). |
Design review minutes, like other documents, can be managed
using the PDXpert change workflow to ensure that all participants
review and approve the document. |
| §820.30(h) Design transfer. Each manufacturer
shall ... ensure that the device design is correctly
translated into production specifications. |
Specialized change forms can be defined to control production
specifications, work instructions and inspection procedures.
Workflows and approval lists may include procurement, production,
quality, service and other affected managers. |
| §820.30(i) Design changes. Each
manufacturer shall establish and maintain procedures
for the identification, documentation, validation or
where appropriate verification, review, and approval
of design changes before their implementation. |
A complete Affected Items list on each change form allows
reviewers to "drill down" into each item, and examine revisions in
terms of production attributes, document and part relations,
electronic file attachments, and other attributes. Impact assessment
may include multiple dispositioning instructions for each affected
item. |
| §820.30(j) Design history file. Each
manufacturer shall establish and maintain a DHF
for each type of device. The DHF shall contain
or reference the records necessary to demonstrate
that the design was developed in accordance with
the approved design plan and the requirements of
this part. |
The PDXpert product structure can directly reference functional
and performance requirements. Verification and validation records
can be separately maintained, or electronic files can be directly
attached to the items that they support. |
| §820.40(a) Document approval and
distribution. Each manufacturer shall
designate an individual(s) to review for
adequacy and approve prior to issuance all
documents established to meet the requirements
of this part. The
approval, including the date and signature
of the individual(s) approving the document,
shall be documented. Documents established
to meet the requirements of this part shall
be available at all locations for which they
are designated, used, or otherwise necessary,
and all obsolete documents shall be promptly
removed from all points of use or otherwise
prevented from unintended use. |
Any number of reviewing departments, each with designated
reviewers, can be assigned to a change workflow. Each reviewer's
response consists of the (1) administrator-assigned reviewer name,
(2) system-assigned date/time of the review, and (3)
reviewer-selected response (approve, disapprove, hold, etc.) to the
proposed change. The implementing change form permits assignment and
closure of document dispositioning tasks, such as delivery of new
released revisions and destruction of canceled revisions. |
| §820.40(b) Document changes.
Changes to documents shall be reviewed
and approved by an individual(s) in the
same function or organization that
performed the original review and approval,
unless specifically designated otherwise.
Approved changes shall be communicated to
the appropriate personnel in a timely manner.
Each manufacturer shall maintain records of
changes to documents. Change records shall
include a description of the change, identification
of the affected documents, the signature of
the approving individual( s), the approval date,
and when the change becomes effective. |
Document changes can be handled using the same change workflow
as the initial approval and release. In addition, distinct "Initial
Release" and "Change Notice" forms may be defined to accommodate,
for example, different approver lists based on differences in
financial or technical impact based on an items lifecycle phase.
Change forms include a primary discussion area and optional
secondary discussion, each with administrator-defined labels and
text templates to ensure complete and consistent user change
descriptions. |
| §820.50(a)(3) Establish and maintain records
of acceptable suppliers, contractors, and
consultants. |
Each item in PDXpert has a Source list that allows one or more
qualified supplier items to be identified, ranked and controlled.
Source items include the full set of item attributes including
supplier, item number, revision, lifecycle phase, materials, cost &
ordering attributes, and specification files. |
| §820.70(a) General. ... Where process controls are
needed they shall include: (1) Documented instructions, standard
operating procedures (SOPs), and methods that define and control the
manner of production; ... (3) Compliance with specified reference
standards or codes; ... (5) Criteria for workmanship which shall be
expressed in documented standards.... |
Specialized change forms can be defined with their own with
workflows and approval lists to control documented production
procedures and methods. Reference standards and codes, as well as
workmanship criteria and inspection procedures, can be directly
linked to the items they affect. |
| §820.70(b) Production and process changes. Each
manufacturer shall establish and maintain procedures for changes to
a specification, method, process, or procedure. ... Changes shall be
approved in accordance with §820.40. |
Changes to production and process documentation can be handled
using the same change workflow as the initial approval and release,
or using a differentiated approval process. |
| §820.90(a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to
specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented. |
New change forms can be defined within PDXpert, including stop
shipment notices, deviations and waivers, each with their own
reviews, observers and workflow. |
| §820.90(b) Nonconformity review and disposition. (1) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use. |
Affected parts listed on implementing change forms can include
disposition instructions (with quantity, cost, current location,
assignee, etc.) for rework, return to vendor, user as-is, and
similar tasks. Dispositioning tasks can be assigned to an individual
who can comment on and close the task. |
| §820.100(a) ... (5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems; (6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems;
... |
All documents affecting the correction and prevention of quality
problems can be recorded, reviewed and approved within PDXpert. Upon
the release of these documents, the change workflow can notify via
email those directly responsible for assuring product quality. |
| §820.181 Device master record. ... The DMR for each type of device shall include, or refer to the location of, the following information: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods. |
In PDXpert, the product structure directly links all appropriate
device specifications; product process specifications; quality
assurance procedures and specifications; packaging and labeling
specifications; installation, maintenance, and servicing procedures
and methods; and any other relevant documentation. Each item on the
structure is automatically updated to reflect the most current
approved and released revision. |
| §820.186 Quality system record. ... The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by §820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with §820.40. |
General procedures required by this part that are not specific
to a particular type of device may be documented and controlled as
any other document or special document type(s) may be created to
ensure these documents are created, reviewed and approved as part of
the QSR data set. |