21 CFR Part 11 Compliance Summarized……..Simply

HeaderGood21 CFR part 11 can be summed up in three words: Verify, Audit, and Track with one guiding compass, honesty. Companies must be able to prove without a shadow of a doubt that any person taking any action within a system is who they say they are. Any action taken within a given environment cannot be changed without documentation and everything done should be accessible for inspection at a later time.

So from this, we can establish that an electronic signature needs to be as trusted as a paper signature, documentation is key, and actions taken can be inspected or audited.

Two key concepts

dreamstime_xs_101635745A closed system is a computer system whose user access is controlled by the same people responsible for its contents. I like to think a good example is being a diary for a company’s equipment. All the juicy secrets are written down or stored and the owner chooses who has access and who doesn’t and mainly known vetted people would be using it.

An open system is a computer where user access is NOT controlled by the same people responsible for its contents. A good example would be Wikipedia, you are given an account with a personally identifying code, but you can add or subtract whatever you want within the platform. Wikipedia can’t confirm who they are prior to giving access to the document so you want to have all the time and date details of when the information was accessed, what was changed and what was original content as well as ensuring that the identifying code given for them to use is on everything they touch

Now for the technical….

A great resource I read was The Ultimate Guide to 21 CFR Part 11 by Marin Richeson, I think the summary was on point and it took legalese and made it digestible. Read it below.

21 CFR Part 11 consists of three Subparts:

A – General Provisions

B – Electronic Records

C – Electronic Signatures

SUBPART A – GENERAL PROVISIONS

  • Part 11 applies to all electronic records that fall under FDA regulations.
  • If an organization can prove to an auditor that their electronic records/signatures are as trustworthy as paper records/ink signatures, the FDA will accept electronic instead of paper.
  • The FDA will accept electronic submission instead of paper IF those submissions 1) adhere to Part 11 requirements and 2) are included among the types of documents that the FDA accepts electronically.

SUBPART B – ELECTRONIC PROVISIONS

  • Organizations using electronic records must establish and document procedures and controls that ensure the following qualities in their electronic records:

– Authenticity

– Integrity

– Confidentiality (when appropriate)

– Irrefutability (i.e., no way to deny that a record is genuine)

  • The following topics must be addressed in documented procedures and controls: computer systems validation (CSV), record rendering, document storage and record retention, system access, audit trails, workflows, authority checks, device checks, personnel qualifications, personnel accountability, and document control.
  • Systems that fall into the category of “Open” (as defined in Sub-part A) require additional procedures/ controls.dreamstime_xs_49436796
  • Electronic signatures must include the printed name of the signer, the date and time of the signature, and the meaning of the signature.
  • Electronic signatures must be forever linked to their respective records.

SUBPART C – ELECTRONIC SIGNATURES

  • Organizations that wish to use electronic signatures must inform the FDA in writing prior to making the switch.
  • Each individual who will be using an electronic signature must

1) have their identity confirmed and

2) use a unique signature that has never been and will never be used by another individual.

  • There are specific design requirements for electronic signatures that are biometric (e.g., fingerprint scan) and those that are not (e.g., user ID and password).
  • For electronic signatures that make use of user IDs and passwords/passcodes, there are specific requirements for passwords and for passcode generating devices.

Final Thoughts

Good stuff, right? At the end of the Day why do you need to be compliant with the FDA?

Because H-O-N-E-S-T-Y.

Altering data is like altering the story the record tells and who put the data changes the record as well. Imagine if you could attribute your name to the great literary arts and say you did it rather than Hemingway or Shakespeare. The difference between a 1 and a 0 have strong implications in binary code. Being compliant or making your equipment complaint with 21CFR part 11 keeps the story true and if it is false, you can see it and find out who is responsible.

Please find a link to the Regulation bellow:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

Link to The Ultimate Guide to 21 CFR Part 11.

https://www.perficient.com/-/media/files/guide-pdf-links/the-ultimate-guide-to-21-cfr-part-11.pdf

 

Written By: Shazib Syed, Engineer I

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Job Posting: Automation Project Manager/Engineer, Greater Baltimore Area

HeaderGoodJob Posting: Automation Project Manager/Engineer

Duration: 6 to 9 months, Initial Term

Positions: 1

Employment Type: ICQ W2

Location: Greater Baltimore Area


EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.

RESPONSIBILITIES

  • Manage the automation & construction project scope including budgeting, project management, resource allocation, integration, validation, data migration, training, SOPs, IT standards and system infrastructure needs to ensure a successful deployment into production.  Oversee documentation of system requirements, functional requirements, technical specifications, and testing protocols using industry standards and the latest GAMP guidelines.
  • Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
  • Customarily and regularly exercises discretionary and independent judgment in performing the job.
  • Participate in training to ensure continued accreditation.
  • Maintain a safe working environment for self, team members and clients operational or administrative staff.
  • Other tasks in alignment with your skills and competencies as required by the project, client and/or management.

REQUIRED EXPERIENCE

  • Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
  • Must be a self-starter, detail oriented and able to work independently with minimal supervision.
  • Excellent troubleshooting skills; ability to react quickly to understand and solve problems.

REQUIRED SKILLS

  • 3 to 5 years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process operations.
  • Project management experience with business and systems analysis, 21 CFR Part 210, 211, 820 and 11, EudraLex Annex 11, ISO, and other GxP computer system validation (CSV), technical practice management, application development, and pharmaceutical clinical liaison.
  • GxP experience in managing the analysis, implementation, and validation of hardware and software solutions for the life sciences industry.
  • GxP experience in managing the analysis, implementation, and validation of hardware and software solutions for the life sciences industry.
  • Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
  • Manage stakeholder expectations, address user, functional, design requirements, and configuration specification; mitigate validation issues, quality on in the project.  Employ industry best practices and processes.

Please note that only local candidates will be considered.


Apply online with the ICQ applicant sourcing platform. This platform is an engineered program designed to improve the candidate sourcing process, and will ultimately provide value to our employees, prospective candidates and clients alike.

Our Applicant Sourcing Platform provides direct access for candidates to seamlessly search for jobs, identify their industry specific skills and competencies, apply for jobs, and review their application status through the entire sourcing process.

The ICQ Applicant Sourcing Platform and associated career portal provides so many benefits to our candidates:

  • Automatic Job Notifications once the portal matches your Photoskills and competencies to any of the jobs posted.
  • Increased Flexibility is
  • provided since you can identify your availability and the system will notify you prior to that time to request updated profile information.
  • Increased Visibility and Exposure to all open positions and clients. Clients can view reports with your qualifications that match their job requirements.
  • Transparent Process lets the candidate track their job application throughout the entire process.

Visit the ICQ Applicant Sourcing Platform today start your journey to a new and better carApply Hereeer.

  • Register with ICQ and create your profile
  • Login to your profile
  • View all current job openings
  • Complete our custom skills matrix

Join our network, follow us, like us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: https://icqconsultants.com.

 

 

Job Posting: Computer System Validation (CSV), Greater Baltimore Area

HeaderGoodJob Posting: Computer System Validation (CSV)

Duration: 3 to 6 months, Initial Term

Positions: 1

Employment Type: ICQ W2

Location: Greater Baltimore Area


EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.

RESPONSIBILITIES

  • Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
  • Customarily and regularly exercises discretionary and independent judgment in performing the job.
  • Participate in training to ensure continued accreditation.
  • Maintain a safe working environment for self, team members and clients operational or administrative staff.
  • Other tasks in alignment with your skills and competencies as required by the project, client and/or management.

REQUIRED EXPERIENCE

  • Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
  • Must be a self-starter, detail oriented and able to work independently with minimal supervision.
  • Excellent troubleshooting skills; ability to react quickly to understand and solve problems.

REQUIRED SKILLS

  • 5 plus years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process operations.
  • Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
  • Direct experience within the following areas; Computer System Validation (CSV), Data Integrity, Standard Operating Procedure (SOP), Change Control, Deviations, Master Validation Plans, Risk Assessments, CAPAs, GMP investigations, Quality Risk Management (QRM), Data Analysis, Process Automation System (PAS), Enterprise System single use technologies.

Please note that only local candidates will be considered.


Apply online with the ICQ applicant sourcing platform. This platform is an engineered program designed to improve the candidate sourcing process, and will ultimately provide value to our employees, prospective candidates and clients alike.

Our Applicant Sourcing Platform provides direct access for candidates to seamlessly search for jobs, identify their industry specific skills and competencies, apply for jobs, and review their application status through the entire sourcing process.

The ICQ Applicant Sourcing Platform and associated career portal provides so many benefits to our candidates:

  • Automatic Job Notifications once the portal matches your Photoskills and competencies to any of the jobs posted.
  • Increased Flexibility is
  • provided since you can identify your availability and the system will notify you prior to that time to request updated profile information.
  • Increased Visibility and Exposure to all open positions and clients. Clients can view reports with your qualifications that match their job requirements.
  • Transparent Process lets the candidate track their job application throughout the entire process.

Visit the ICQ Applicant Sourcing Platform today start your journey to a new and better carApply Hereeer.

  • Register with ICQ and create your profile
  • Login to your profile
  • View all current job openings
  • Complete our custom skills matrix

Join our network, follow us, like us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: https://icqconsultants.com.

 

 

Job Posting: Computer System Validation (CSV)

HeaderGoodJob Posting: Computer System Validation (CSV)

Duration: 3 to 6 months, Initial Term

Positions: 4

Employment Type: ICQ W2

Location: Greater Boston Area


EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.

RESPONSIBILITIES

  • Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
  • Customarily and regularly exercises discretionary and independent judgment in performing the job.
  • Participate in training to ensure continued accreditation.
  • Maintain a safe working environment for self, team members and clients operational or administrative staff.
  • Other tasks in alignment with your skills and competencies as required by the project, client and/or management.

REQUIRED EXPERIENCE

  • Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
  • Must be a self-starter, detail oriented and able to work independently with minimal supervision.
  • Excellent troubleshooting skills; ability to react quickly to understand and solve problems.

REQUIRED SKILLS

  • 2 to 6 years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process operations.
  • Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
  • Direct experience within the following areas; Computer System Validation (CSV), Data Integrity, Standard Operating Procedure (SOP), Change Control, Deviations, Master Validation Plans, Risk Assessments, CAPAs, GMP investigations, Quality Risk Management (QRM), Data Analysis, Process Automation System (PAS), Enterprise System single use technologies.

Please note that only local candidates will be considered.


Apply online with the ICQ applicant sourcing platform. This platform is an engineered program designed to improve the candidate sourcing process, and will ultimately provide value to our employees, prospective candidates and clients alike.

Our Applicant Sourcing Platform provides direct access for candidates to seamlessly search for jobs, identify their industry specific skills and competencies, apply for jobs, and review their application status through the entire sourcing process.

The ICQ Applicant Sourcing Platform and associated career portal provides so many benefits to our candidates:

  • Automatic Job Notifications once the portal matches your skills and competencies to any of the jobs posted.Candidate_46362702
  • Increased Flexibility is provided since you can identify your availability and the system will notify you prior to that time to request updated profile information.
  • Increased Visibility and Exposure to all open positions and clients. Clients can view reports with your qualifications that match their job requirements.
  • Transparent Process lets the candidate track their job application throughout the entire process.

Visit the ICQ Applicant Sourcing Platform today start your journey to a new and better carApply Hereeer.

  • Register with ICQ and create your profile
  • Login to your profile
  • View all current job openings
  • Complete our custom skills matrix

Join our network, follow us, like us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: https://icqconsultants.com.