Document Control in Regulated FDA Environments - When and how to stick with paper

Document Control in FDA Regulated Environments: When (and how) to stick with paper

Melita Ball

Regulatory & Quality Training

Remediation

Warning Letter mitigation

Quality System Development

21 CFR Part 11

Software Validation

Supplier Qualification & Management

Auditing

Document Control

Production & Process Control

CAPA

Complaint Handling

Management Controls

Project Management

• Principal Consultant, MBC & Affiliates, LLC (MBCA)

• 25+ years working in FDA regulated environments

• Global Consulting Firm specializing in regulatory compliance and quality system

Agenda

Predicate Rules

Why paper-based systems are simple

Why paper-based systems are complex

How to do it right … on paper

When is it time to automate?

Predicate Rules:Documents & Records

Definition

A predicate rule is any requirement listed in FDA regulations that requires compliance to demonstrate a “state of control.”

Since these rules were originally written for paper-based quality systems, it is sometimes difficult to translate those rules into the variety of systems that exist in today’s modern manufacturing environments.

In today’s session, we will focus our attention on the predicate rules as they apply to documents & records.


Historical Background

Most regulated companies implemented their first quality system on paper because technology was not what it is today.

Since then, computer systems and automated tools have burst into our daily lives and have made their way into companies with the promise of working smarter & faster.


Historical Background

Automation has also allowed companies to achieve more consistent results with less human error and to make better data-driven decisions.

All of this sounds fantastic to most people, until they are faced with implementing those tools in a way that ensures not only compliance with the predicate rules but also ensures they can actually rely on the data and information coming out of the system.

Predicate Rules Summarized

What are they?

Predicate Rules: Summarized

Documents

1. Approvals with date and signature

2. Documents must be available at the point of use

3. Obsolete documents must be prevented from unintended use

4. Changes must be reviewed approved with date & signature

5. Approved changes must be communicated to the people who need them in a timely manner

6. Must maintain change history of each document that includes a description of the change, a list of affected document, signature/date of approval, & when change becomes effective.

Predicate Rules: Summarized

Records

1. Maintained at the location of use or reasonable accessible during an inspection.

2. All records must be made readily available for review and copying by the FDA

3. Must be stored to minimize deterioration and prevent loss

4. Must be legible

5. Must be retained for appropriate period of time according to individual regulations.

8 Rules of Recordkeeping1. Always use ink to create a permanent record.

2. Provide all requested information. Never leave unexplained blank spaces.

3. Always correct mistakes by drawing a single line through your error insert the correct information, initial and date the correction.

4. Never use whiteout or anything else to hide the original entry. You must be able to read the original entry.

8 Rules of Recordkeeping5. Always sign and date any Quality System Record.

6. Always write neatly and legibly.

7. When recording data, always copy information directly to the data sheet or notebook. Never record data on scrap paper or post-it-notes.

8. Always record ALL data. Never be selective. You must be able to explain & justify any data not recorded

Paper: Beautiful Simplicity & Ugly

Complexity

Now, lets take a quick look at how most companies

implement these requirements in a paper-based system.

Paper Documents

Paper Documentso Approvals with date and signature

Paper Documentso Documents must be available at the point of

use

Paper Documentso Obsolete documents must be prevented

from unintended use

Paper Documentso Changes must be reviewed and approved

date/signature

Paper Documents

o Approved changes must be communicated to the people who need them in a timely manner

Paper Documents

o Must maintain change history of each document that includes a description of the change, a list of affected documents, & when change becomes effective.

Paper Records

Paper Records

o Maintained at the location of use or reasonable accessible during an inspection.

Standard practice is to maintain the quality system records for a specified period of time in one central location in the organization for easy retrieval.

Older records that still need to be kept but are in the archive stage should be sent to an offsite location for long term storage.

Paper Recordso All records must be made readily available for review

and copying by the FDA.

Throughout the record retention period, records must be able to be retrieved within a reasonable amount of time during inspections.

If the records are recent and you’ve done a good job of centralizing and organizing them, this is not a huge problem but what if the documents are old and have already been moved into long-term storage?

They must be close enough to retrieve them within a reasonable amount of time for FDA inspections.

If you use a third-party vendor like Iron Mountain, you need to negotiate guaranteed delivery time-frames into the contract.

Paper Recordso Must be stored to minimize deterioration and

prevent loss

This is an extremely important concept in the paper world because paper does deteriorate over time and it can easily be destroyed by water, fire and other natural disasters.

Industry standard for short-term storage

Fire & water rated file cabinets

Industry standards for long-term storage

Storage rooms with fire rating

Temp & humidity systems with notifications

Water detection systems if location is in basement or below sea level or in an area that frequently floods

OR – contract with a document management company to do it for you (Iron Mountain)

Paper Records

o Must be legible

o This seems like a simple requirement but it is difficult to control consistently with paper records.

o Even if you use electronic tools to create records where possible (Word, Excel, etc.), employees will eventually need to manually enter data on a paper record with a pen.

o Industry Standard is to require all employees to print information on a form (no script writing allowed) and monitor legibility during internal audits that look at records.

Paper Records

o Must be retained for appropriate period of time according to individual regulations.

o Depending on which FDA segment you fall into and your products general expected life, this can vary widely from company to company.

o One of the most stringent requirements is for complex medical equipment that can have a 25-30 year life in the field. For these systems, paper records will need to be maintained for the expected life of the device PLUS two years.

o Retrieval of records is the least of your worries as deterioration of the paper and/or ink become a more important factor.

8 Rules of Recordkeeping:Paper vs. Electronic

PaperBlue or black ink is the best because they have more carbon and last longer when archivedNo gel or erasable inkNo pencil

ElectronicRecord is electronic but should be printable. Laser printers are best for “permanence”

E-Systems need to be validated to ensure the record is permanent after saving and cannot be subsequently changed.

Backups, archives, system maintenance

1. Always use ink to create a permanent record.


PaperIf the approved form has a space for data, it must have something in it or an explanation for why it was left blank.N/A is not always sufficient and sometimes will require an explanation.

ElectronicOptimally, the E-System will be workflow enabled and this can be validated.

If not, controls need to be in place at the field level that prevent a user from moving forward with blank fields.

2. Provide all requested information. Never leave unexplained blank spaces.


PaperEvery mistake on a record must be corrected using the above method.

ElectronicThis rule is accomplished by valid audit trails that show who made the change, when, why, and the old and new values for the field in question.

Out of the box in many systems but validation still needed.

3. Always correct mistakes by drawing a single line through your error insert the correct information, initial and date the correction.


PaperWhiteout, whiteout tape, markers that obstruct the previous information, etc.Also includes scribbling out the old value.Must be able to read the old and new values.

ElectronicIn an E-System, it is the same solution as the previous slide

Audit Trails that have been validated.

4. Never use whiteout or anything else to hide the original entry. You must be able to read the original entry.


PaperWe covered this earlierFairly simple and self-explanatory

ElectronicMust be the equivalent of a persons hand-written signature

Signature cannot be denied in a court of law

Much more complex than a simple hand-written signature (Part 2)

5. Always sign and date any Quality System Record.


PaperHarder to controlHarder to maintain for the long termMust be a part of ongoing improvement efforts and monitored for effectiveness

ElectronicBarring simple typos, much easier to maintain neat and legible records using electronic systems.

Interfaces to other systems, table-driven data fields that auto-populate or have a logical tree or are select fields all must be thoroughly validated to ensure data integrity and accuracy.

6. Always write neatly and legibly.


PaperHarder to controlHarder to maintain for the long termMust be a part of ongoing improvement efforts and monitored for effectivenessMust be part of ongoing training efforts.

ElectronicSome of the same issues as paper if employees insist on writing it down before entering into the system

In addition to control listed on left side, there may be a need to invest in technology to make it easier to comply (tablets, laptops, etc.)

7. When recording data, always copy information directly to the data sheet or notebook. Never record data on scrap paper or post-it-notes.


PaperDependent upon the enforcement of #7Difficult to detect but consequences are severe if found.

ElectronicDependent upon the enforcement of #7

Difficult to detect but consequences are severe is found.

8. Always record ALL data. Never be selective. You must be able to explain & justify any data not recorded

Paper to Software Test

When do you know “it’s time to automate?”

The Paper to Software Test

1. How many documents do you currently have in your quality system

2. How many records do you have?

3. On average, how many records does your company create every week?


4. Do you have relatively-stable process for document changes?

5. Do you have relatively-stable process for product & process changes?

6. How many employees to you have using and changing documents and creating records?


1. How many documents to you currently have in your quality system?

1 – 150 = 1

151 – 550 = 3

More than 550 = 5


2. How many records do you have?

1 – 1,000 = 1

1,001 – 5,000 = 3

More than 5,000 = 5


3. On average, how many records does your company create every week?

1 – 15 = 1

16 – 50 = 3

More than 50 = 5


4. Do you have relatively-stable process for document changes?

Document Changes:

Yes = 5

No = 1


5. Do you have relatively-stable process for product & process changes?

Product & Process Changes:

Yes = 5

No = 1


6. How many employees to you have using and changing the documents and creating records?

1 – 25 = 1

26 – 75 = 3

More than 75 = 5


Add the answers to each of the six

questions together for a total score

Paper to Software Test Answers

If your total score is from 6 to 13, you either don’t need or are not ready to implement an electronic system.

If you received this score based on the answers to questions 4 & 5, then more experience is still needed to understand change control requirements. Once these are well understood and stabilized, you will likely be ready to implement and electronic system in a cost effective way.


If your total score is from 14 to 23, you are a great candidate to move from paper to an electronic system.

Additionally, the timing is perfect to optimize the transition.

You likely have worked out most of the process issues on paper and have a good grasp of what’s needed and why.


If your total score is from 24 to 30, you have waited too long already.

Get moving!

It’s past time to automate and the sooner you transition, the easier your life will become.

You likely have introduced a fair amount of complexity into your processes and it will be important for you to get some help to ensure you select the right system and make necessary adjustments to fit into your culture with minimal interruption.

Don’t Miss Part 2!

June 24th at 1:00 Eastern / 10:00 Pacific

Sign up at http://tinyurl.com/ZQpart2 or look for an email from ZenQMS shortly

In part 2 we will take a deep dive into what it takes to prepare your organization for a successful transition to a software driven system.

http://tinyurl.com/ZQpart2

http://tinyurl.com/ZQpart2

THANK YOU!MELITA BALL, PRINCIPAL CONSULTANT

MBC & AFFILIATES, LLC & ZenQMS

www.mbcaconsulting.com(520) 665-9081

[email protected]

www.zenqms.com(267) 670 8999

http://www.mbcaconsulting.com/

mailto:[email protected]

http://www.zenqms.com/

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Document Control in Regulated FDA Environments - When and how to stick with paper