Chapter 1: Good Documentation Practices
8 Regulatory Affairs Professionals Society
o Market and launch documentation
o Proof of compliance with acceptable practices and
International Organization for Standardization
requirements
o Pharmacovigilance reports
o Periodic safety update reports
o Medical information communications
o Annual reports
o Supplemental application filings
o Benefit-risk evaluation reports
o Postmarket study requirements/commitments
o Advertising and promotional materials and references
Good Practices for Signatures, Change
Control, Validation, and Dating
If records are kept electronically, the system must be validated
and backed up, and access should be limited to maintain
control over any changes. Under GDPs, only the most current
document may be used for any given purpose, and change
control is a must. Each document should be assigned an
internal control number, and revisions should be tracked.
Originators, reviewers, and approvers should be identified
and have appropriate qualifications to support their respective
decisions.
Documentation should be dated in real-time and never
pre-or postdated. Any retrospective additions, modifications,
or deletions should be signed and dated having these changes
witnessed should be considered.
The time an organization should retain any given docu-
mentation can vary, so care should be taken before destroying
any records. Maintaining a records retention schedule for
the different types of records produced should be considered.
SOPs on record retention, destruction of records and long-
term storage of records are a must. Documents often require
signatures. No document should be signed unless it is under-
stood, and the contents are supported.
An organization’s documents can be pivotal in a product
liability or personal injury case, and it is possible they will be
demanded during court proceedings. Likewise, any person
within an organization responsible for that documentation
also may be called into court. The credibility of a witness or
a product’s quality can be influenced greatly by implement-
ing GDPs. In today’s increasingly litigious environment, all
documentation should be viewed through the lens of could
this document be explained, justified, or defended in a court
of law?
Recordkeeping, Review, and Training
Organizations are understandably focused on getting a prod-
uct to market, but good documentation improves processes
and, ultimately, the bottom line. An organization’s quality sys-
tem is based on its documentation system. Even with the best
intentions, individual differences in execution or interpreta-
tion can result in inconsistencies and compromise product
quality. That is why it is best to implement a GDP system at
the earliest stages to minimize subjective interpretation.
Good documentation is a significant investment that
may not bring immediate returns but provides important
protection against internal inconsistencies, adverse regulatory
actions, and legal liabilities. The human resources required to
respond to a Form FDA 483 warrant the upfront investment
in a documentation system that will mitigate communication,
performance, and recordkeeping failures. Any findings of
deficiencies are on the public record, available to competitors
and customers alike.
Any documentation system should contain clear,
consistent, and focused documents, including SOPs, work
instructions. and training materials. Inconsistencies or
ambiguities can have devastating effects on an organization’s
operations. Thus, documents should be reviewed periodi-
cally and reconciled with each other to minimize confusion
among users. The organization should determine which are
specific to its operations and customize policies and proce-
dures accordingly. For example, processes and procedures not
currently in place, even if they were previously, should not be
documented.
Change control will ensure all users are using the most
up-to-date version of a document, and an organized change
control procedure should be developed and followed. A doc-
ument change control system is intended to capture changes
made to existing documentation and provide a means of
tracking these changes and communicating them throughout
an organization.
If an organization’s operations deal with medical devices
and pharmaceuticals, documentation for each product type
should be maintained separately. Likewise, specific provisions
may be necessary for documents related to an organization’s
pharmaceutical products if they are Drug Enforcement
Administration (DEA)-controlled substances, biologics,
generics, etc.
Once the documentation system is in place, it should not
be neglected or abandoned. Changes should be considered
regularly, following schedules mandated in regulations or
in conjunction with other appropriate events. Additionally,
the system should be kept in a validated state at all times.
Meaning that any changes to the system should be assessed
using risk management tools and if needed those changes
should be validated. The documentation from this process
must be maintained to ensure compliance with all regulations
and internal procedures. In the event of an audit, the trail
of the changes made, the dates of those changes, and the
parties responsible for them should be identified easily, and
support for those changes should be kept on file accordingly.
Documenting the obvious can make short work of inspec-
tions. One test for whether updates are required is to answer
the question, can you explain how this (i.e., the subject matter
of the document) all works? It is not unreasonable for an
auditor or inspector to expect a document user to explain
the contents or their relevance to business operations. If a
document, as written, cannot translate information to the
reader to allow informed decisions to be made, reworking the
document is advisable.
Training, vital to success, is only as good as the docu-
mentation on which it is based. High-quality documents are
8 Regulatory Affairs Professionals Society
o Market and launch documentation
o Proof of compliance with acceptable practices and
International Organization for Standardization
requirements
o Pharmacovigilance reports
o Periodic safety update reports
o Medical information communications
o Annual reports
o Supplemental application filings
o Benefit-risk evaluation reports
o Postmarket study requirements/commitments
o Advertising and promotional materials and references
Good Practices for Signatures, Change
Control, Validation, and Dating
If records are kept electronically, the system must be validated
and backed up, and access should be limited to maintain
control over any changes. Under GDPs, only the most current
document may be used for any given purpose, and change
control is a must. Each document should be assigned an
internal control number, and revisions should be tracked.
Originators, reviewers, and approvers should be identified
and have appropriate qualifications to support their respective
decisions.
Documentation should be dated in real-time and never
pre-or postdated. Any retrospective additions, modifications,
or deletions should be signed and dated having these changes
witnessed should be considered.
The time an organization should retain any given docu-
mentation can vary, so care should be taken before destroying
any records. Maintaining a records retention schedule for
the different types of records produced should be considered.
SOPs on record retention, destruction of records and long-
term storage of records are a must. Documents often require
signatures. No document should be signed unless it is under-
stood, and the contents are supported.
An organization’s documents can be pivotal in a product
liability or personal injury case, and it is possible they will be
demanded during court proceedings. Likewise, any person
within an organization responsible for that documentation
also may be called into court. The credibility of a witness or
a product’s quality can be influenced greatly by implement-
ing GDPs. In today’s increasingly litigious environment, all
documentation should be viewed through the lens of could
this document be explained, justified, or defended in a court
of law?
Recordkeeping, Review, and Training
Organizations are understandably focused on getting a prod-
uct to market, but good documentation improves processes
and, ultimately, the bottom line. An organization’s quality sys-
tem is based on its documentation system. Even with the best
intentions, individual differences in execution or interpreta-
tion can result in inconsistencies and compromise product
quality. That is why it is best to implement a GDP system at
the earliest stages to minimize subjective interpretation.
Good documentation is a significant investment that
may not bring immediate returns but provides important
protection against internal inconsistencies, adverse regulatory
actions, and legal liabilities. The human resources required to
respond to a Form FDA 483 warrant the upfront investment
in a documentation system that will mitigate communication,
performance, and recordkeeping failures. Any findings of
deficiencies are on the public record, available to competitors
and customers alike.
Any documentation system should contain clear,
consistent, and focused documents, including SOPs, work
instructions. and training materials. Inconsistencies or
ambiguities can have devastating effects on an organization’s
operations. Thus, documents should be reviewed periodi-
cally and reconciled with each other to minimize confusion
among users. The organization should determine which are
specific to its operations and customize policies and proce-
dures accordingly. For example, processes and procedures not
currently in place, even if they were previously, should not be
documented.
Change control will ensure all users are using the most
up-to-date version of a document, and an organized change
control procedure should be developed and followed. A doc-
ument change control system is intended to capture changes
made to existing documentation and provide a means of
tracking these changes and communicating them throughout
an organization.
If an organization’s operations deal with medical devices
and pharmaceuticals, documentation for each product type
should be maintained separately. Likewise, specific provisions
may be necessary for documents related to an organization’s
pharmaceutical products if they are Drug Enforcement
Administration (DEA)-controlled substances, biologics,
generics, etc.
Once the documentation system is in place, it should not
be neglected or abandoned. Changes should be considered
regularly, following schedules mandated in regulations or
in conjunction with other appropriate events. Additionally,
the system should be kept in a validated state at all times.
Meaning that any changes to the system should be assessed
using risk management tools and if needed those changes
should be validated. The documentation from this process
must be maintained to ensure compliance with all regulations
and internal procedures. In the event of an audit, the trail
of the changes made, the dates of those changes, and the
parties responsible for them should be identified easily, and
support for those changes should be kept on file accordingly.
Documenting the obvious can make short work of inspec-
tions. One test for whether updates are required is to answer
the question, can you explain how this (i.e., the subject matter
of the document) all works? It is not unreasonable for an
auditor or inspector to expect a document user to explain
the contents or their relevance to business operations. If a
document, as written, cannot translate information to the
reader to allow informed decisions to be made, reworking the
document is advisable.
Training, vital to success, is only as good as the docu-
mentation on which it is based. High-quality documents are