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Data Integrity and CSV Compliance Solutions

for Drug Manufacturers

Introduction

The term “data integrity” refers to the completeness, consistency, and accuracy of

generated data. Ensuring data integrity in drug manufacturing operations is not a new

concept - it has been part of the pharmaceutical industry landscape for many decades.

What is new, comparatively speaking, is data integrity protocols for today’s highly digitized

validation,” or CSV, is often mentioned in tandem with data integrity.

Effective data governance programs for drug manufacturing operations will contain

many of the same basic components across the industry. Regulatory requirements for

such vary from country to country.

Here, we review the data integrity and CSV regulatory setting in the United States

(US) and the European Union (EU), discuss some of the trends and challenges drug

manufacturers face, and identify best practices to help them succeed in their data

integrity compliance efforts.

2

Agencies and Regulations

practices of Annex 11 do not have the force of law, but they

are strongly recommended to ensure electronic data integrity is

achieved and maintained.

In the US, the federal Food and Drug Administration (FDA)

uses the rules in 21 CFR Part 11 [2] to evaluate and enforce

data integrity requirements for electronic records and

signatures in drug manufacturing operations. Part 11 defines

an electronic record as:

“any combination of text, graphics, data, audio, pictorial, or

other information representation in digital form that is created,

handwritten signature.”

Although Part 11 focuses specifically on electronic records

and signatures, in practice it is part of the broader good

manufacturing practices (GMP) stipulated in 21 CFR Part 211.

[3] For example, Part 11 and Part 211 dovetail in their data

integrity criteria: attributable, legible, contemporaneously

recorded, original, and accurate, commonly known as ALCOA.

Part 11 also overlaps with 21 CFR 312.23(7) concerning the

data integrity of chemistry, manufacturing, and control (CMC)

information required for investigational new drugs before they

FDA Viewpoint of Data Integrity

2. Computer- generated, time-stamped audit trails

3. Compliance of “legacy” systems that were operating before

Part 11’s effective date of August 20,1997 but have been

subsequently modified

4. Ability for FDA to inspect, review, and copy records

5. Proper records retention based on “a justified and documented

risk assessment and a determination of the value of the records

over time.”

When inadequacies are noted, the FDA issues a letter to the

company detailing the violation(s) found. When there is no

resulted in contaminated products, adverse reactions in users,

egregious gaps in a data quality program, and others can result

in manufacturing shutdown, product recall, or other serious

consequences, including hefty fines.

The FDA maintains a database of their inspection findings

and conclusions, which can be helpful for manufacturers in

compliance planning and program review. It is not uncommon

for FDA to increase inspections for violations that are noted

to be on the increase. The agency sometimes issues guidance

documents in order to help manufacturers better understand and

and Answers Guidance for Industry

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data generation and analysis to archiving and destruction. One of

the most challenging compliance points in that lifecycle is at the

end-of-life for hardware or software. The data must be archived

or migrated to a new instrument or system, which can be difficult

when the components do not easily integrate with each other.

Preparing for these inevitable transitions should be an important

part of a company’s instrument and software continuity planning

and data integrity program.

The pharmaceutical industry and related professional

organizations have been increasing their efforts to develop

thorough evaluations when selecting instrumentation and

software. In addition to price point and performance capabilities,

they are looking for data integrity and CSV competencies

that will help them meet or exceed security requirements and

maintain complete audit trails, among other data integrity

considerations. In response to these demands, hardware and

software companies are integrating data integrity considerations

into their new or updated products.

A growing trend within the drug manufacturing industry is the

creation of corporate data integrity governance programs. Such

the knowledge, authority, and dedicated time needed to oversee

the program. The committee and manager must work together

to develop well-defined data integrity policies and practices,

including routine data integrity assessments. The data integrity

manager must have ownership of implementing, monitoring, and

adjusting those policies and practices as needed over time, with

committee input.

The expertise and experiences of other organizations can

be very helpful when developing a data integrity program.

The committee and manager should seek out information