Data Integrity Experts in Pharma, Life Science, Healthcare Industry

What is CSV in pharma industry?
According to both American FDA and UK MHRA, computer system validation is defined as

“Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”

Purpose of CSV:
The purpose of the validation process is to provide a high degree of assurance that a specific process (or in this case computer system) will consistently produce a product
(control information or data) which meets predetermined specifications and quality attributes

Need of CSV:
FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.

Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.

CSV Processes:
Let’s look V-Model step-by-step breakdown

1 Master Planning
2 User Requirement Specifications
3 Functional Specification
4 Design Specifications
5 Configuring a system build
6 IQ tests
7 OQ test
8 PQ tests
9 Reporting.

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You must know Techniques that followed by your next

What is ?
QSIT provides to field staff on inspection process used to assess manufacturer's with

An FDA quality system inspection technique focuses primarily on four major subsystems & their respective samples & is an efficient way to determine systemic weaknesses.

When an investigator conducts an FDA QSIT inspection companies can expect shorter audits & more serious repercussions especially to upper management.

QSIT identifies four major subsystems of Quality System:
1 Management Controls
2 Design Controls
3 Corrective & Preventive Actions (CAPA)
4 Production & Process Controls

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Traits on which Interviewee will be judged

Interviewer follow Warren Buffet said:

"Always look for three qualities in hiring people : INTEGRITY, INTELLIGENCE & ENERGY. And if you don’t have the first, the other two will kill you"

Showcasing your potential can help you land the job and here's why

By focusing on a candidate’s personality, companies can find someone who can ‘fit in’ with the organization, which is a win-win for both parties

1 Desire to Learn and Grow
2 Correct Professional Image
3 Emotional Intelligence
4 Intellectually Curious
5 Experience Subject Knowledge
6 Enthusiasm and Interest
7 Clarity of Goals
8 Honest, Trustworthy, and Reliable
9 Personal Characteristics
10 Self-Expression
11 Team & Results-Oriented
12 Stress Management
13 Sense of Humor
14 Personality
15 Communication skills
16 General Awareness
17 Respectful
18 Passionate
20 Flexible
21 Maturity
22 Dedicated
23 Diligence
24 Confident

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Mind Blowing

What is Open, Closed & Hybrid system:

Open System:

A computer system where user access is not controlled by the same people responsible for its contents.

Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

The company cannot confirm the identity of all users prior to providing access to the electronic record system.

Closed System:

A Computer system whose user access is controlled by the same people responsible for its contents.

Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.



The company can confirm the identity of all users prior to providing access to the electronic record system and only electronic signatures are required.

Hybrid System:

An environment consisting of both Electronic & paper-based Records (frequently characterized by handwritten signatures Executed on paper).



Hybrid systems combining electronic and paper-based records preserve the paper-based workflow. Realizing the full benefits of working electronically requires the implementation of electronic signatures

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Legacy Systems in pharma industry

Let’s be honest: No one really likes legacy systems

Companies get in trouble because

- Something else goes wrong

- There’s a compliance issue

- Roll-out is too difficult to do all at once

- Ongoing projects require older software/hardware

- Decision makers who just don’t like change

What is Legacy system?

it is an old method, technology, computer system, or application program relating to previous or outdated computer system

This can also imply that the system is out of date or in need of replacement

Following criteria are met for a specific Legacy System

• System was operational before the effective date

• System met all applicable predicate rule requirements before effective date

• System currently meets all applicable predicate rule requirement

• You have documented evidence & justification that the system is fit for its intended use(including having an acceptable level of record security & integrity

Challenges in Legacy System

- Limited options are available in legacy system

- Maintenance was problematic due part unavailability

- No highly accurate result

- Not easily integrate with new technology

Why Decommissioning of Legacy System

· Save money

· Ensure compliance

· Find Record Faster

· Get higher security

Data Integrity

Software & Its category in pharma industry

Use of in is continuously increasing.

It can be used across a broad range of platforms, including , “off-the-shelf” platforms & networks to name a few.

What is ?
Glossary published in 1995, defines COTS as “configurable, off-the-shelf software,”

What is 5?
GAMP, Founded in 1991. ISPE sets the for & current Version is GAMP 5

GAMP describes a set of principles & procedures that help ensure that Software have required .

Why GAMP 5?
- Facilitates interpretation of requirement
- Establishes a common & terminology
- a system life cycle approach based on good practice
- Clarifies roles & responsibilities

of Software
GAMP software categories were originally introduced to provide an initial assessment as to requirement.

GAMP 4, there were five category
Cat 1: Operating Systems
Cat 2:
Cat 3: Standard Software
Cat 4: Configured Software
Cat 5: Custom Software

In GAMP 5, these have been revised to four categories
i.e. Cat2 has been removed. This related to firmware.

For more details download
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Data Integrity

What is CSV in pharma industry?
According to both American FDA and UK MHRA, computer system validation is defined as

“Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”

Purpose of CSV:
The purpose of the validation process is to provide a high degree of assurance that a specific process (or in this case computer system) will consistently produce a product
(control information or data) which meets predetermined specifications and quality attributes

Need of CSV:
FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.

Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.

CSV Processes:
Let’s look V-Model step-by-step breakdown

1 Master Planning
2 User Requirement Specifications
3 Functional Specification
4 Design Specifications
5 Configuring a system build
6 IQ tests
7 OQ test
8 PQ tests
9 Reporting.

Link:
https://lnkd.in/fgBUpki
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Data Integrity

History of CSV

The concept of validation was derived from engineering principles of validation of mechanical system that has been extended to the software industry.

To extend it further during mid-1970’s, Ted Byers and Bud Loftus, two FDA officials first proposed the concept of validation in order to improve the quality of pharmaceuticals (Agalloco 1995).

In 1987 the FDA published a document entitled ‘FDA Guidelines on General Principles of Process Validation’.

It state that "Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes."

Feeling the necessity of Validation, FDA published a guide to the inspection of Computerized Systems in Pharmaceutical Processing, also known as the ‘bluebook’ (FDA 1983).

For MHRA this is Annex 11 of the EU GMP regulations (EMEA 1998), whereas for American FDA, this is 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997).

FDA issued final part 11 regulations In March of 1997, became effective in August 1997 & Revised in August 2003

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Data Integrity

Static vs Dynamic Record

Static Record

A static record format, such as a paper or electronic record, is one that is fixed and allows little or no interaction between the user and the record content

Static record is used to indicate a fixed-data record such as a paper record or an electronic image



Static data is data that does not change after being recorded. Its a fixed data set

For eg, once printed or converted to static electronic format chromatography records lose the capability of being reprocessed or enabling more detailed viewing of baselines

Dynamic Record

Records in dynamic format, such as electronic records, allow an interactive relationship between the user and the record content

For eg, electronic records in database formats allow the user to track, trend and query data; chromatography records maintained as electronic records allow the user or reviewer

(with appropriate access permissions) to reprocess the data and expand the baseline to view the integration more clearly.

Dynamic means that the record format allows interaction between the user and the record content experts contrast static data with dynamic data

Where dynamic data may change after it is recorded, and has to be continually updated

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Basic concepts in Phama Industry:

Closed system:

"An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system" (21 CFR 11.3(b)(4)).

Open system:

"An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system" (21 CFR 11.3(b)(9)).

Electronic Record:

"Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system" (21 CFR 11.3(b)(6)).

Digital Signature:

"An Electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified" (21 CFR 11.3(b)(5)).

Electronic Signature:

"A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature" (21 CFR 11.3(b)(7))

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Data Integrity