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The Food and Drug Administration (FDA) is a US agency that ensures that food is safe and wholesome, that cosmetics will not harm humans and that medicines, medical devices and radiation-emitting consumer products are safe and effective. The FDA also protects the public health by assuring the safety, effectiveness, quality and security of human and veterinary drugs, vaccines and other biological products.

FDA regulatory compliance process includes reviewing regulated product, clearing products for sale, and maintaining post market surveillance.

Industries the FDA Regulates

According to the Food and Drug Administration, the FDA is the government agency responsible for reviewing, approving and regulating medical products, including pharmaceutical drugs and medical devices. It also regulates various other products, including food, cosmetics, veterinary drugs, radiation-emitting products, biological products and tobacco.

According to various FDA Warning Letters, here are some examples of common compliance mistakes:

  • “Failure to adequately validate according to established procedures.”
  • “Failure to review and approve design output before release.”
  • “Failed design validation that ensures the medical device conforms to defined user needs and intended users.”
  • “Failure to adequately establish procedures for acceptance of incoming product.”

Why Arbour Group for FDA Compliance and Validation

Arbour Group provides packaged compliance solutions to companies in the life sciences industries looking to meet FDA regulations or other international regulations. We provide an alternative to manual labor-intensive validation efforts with a prepared compliance package incorporated with industry best practices. Some of Arbour Group’s services used to meet FDA regulations include software validation, infrastructure qualification, and supplier audits.

Arbour Group's regulatory products include packaged validation protocols that help clients ensure that key ERP solutions are functional and in compliance with applicable regulations to minimize business risk. The process includes a validation plan template that scopes out the validation process, test script development that sets up the test objective, a business requirements model, and a traceability matrix. The package includes installation qualification test scripts, operation qualification test scripts, a performance qualification template, and a validation summary report template.

Our Track Record with FDA Compliance and Validation

  • Documented evidence that regulated functionality has been successfully tested for its intended uses
  • Procedures are in place to govern the use of the system and protection of data, i.e., SOPs/WIs, etc.
  • Training of users is evident in records
  • Change Control is maintained

Whether dealing with FDA regulatory compliance requirements or other international regulations, Arbour Group can provide compliance solutions for medical device, pharmaceutical, and other life sciences regulation needs. Our expert services will assist in the proper preparation of FDA inspections and will manage you business risk quickly and reliably.

How We Ensure Compliance with 21 CFR Part 11

Arbour Group delivers effective products and services that reduce the cost of compliance.
The Arbour Advantage delivers warranted solutions for managing compliance across the end-to-end supply chain at Life Sciences companies.

21 CFR Part 11 Compliance Checklist

CFR Part 11 was established by the FDA in 1997 and clarified in 2007 and it applies to Electronic Record & Electronic Signatures and their related rules. CFR Part 11 establishes a requirement that computer systems used to create, modify and maintain electronic records & signatures are subject to validation. Computer systems (including hardware and software), controls and documentation must be readily available for and subject to FDA inspection and predicate rules apply, i.e., GMP, GCP, GLP.

According to the FDA, key elements of 21 CFR Part 11 include:

  • Validation of systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records.
  • Ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review and copying.
  • Protection of records to enable accurate and ready retrieval throughout the record retention period.
  • Limiting access to authorized individuals.
  • The use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries.
  • Record changes shall not obscure previously recorded information and audit trails are to be maintained as long as the associated electronic record.
  • Use operational system checks to enforce permitted sequencing of steps and events, as appropriate.
  • Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation, alter a record or perform the operation at hand.
  • Use of device checks to determine the validity of the source of data input.
  • Determination that persons who develop, maintain or use electronic records/electronic signatures have the education, training and experience to perform the assigned tasks.
  • The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signature so as to deter signature falsification.
  • Adequate control over the distribution of, access to and use of documentation for system operation and maintenance.
  • Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of system documentation.

According to the FDA, key elements of 21 CFR Part 11 include:

Q: What are the Validation Deliverables?
A: The Validation Deliverables include:

  • Validation Plan
  • User Requirements
  • Functional Specification
  • IQ/OQ/PQ Protocols
  • Validation Summary Report

Q: What needs to be validated?
A: Finished Pharmaceutical GMPs such as:

  • Personnel Qualifications (211.25), Consultants (211.34)
  • Equipment Cleaning and Maint. (211.67)
  • Automated Equipment (211.68)
  • Materials Examination and Usage (211.122)
  • Packaging and Labeling Oper. (211.130)
  • Drug Product Inspection (211.134)
  • Distribution Procedures (211.150)
  • Reserve Samples (211.170)
  • Records and Reports (211.180)

A: Medical Device GMPs such as:

  • Management Responsibility (820.20)
  • Quality Audit (820.22)
  • Personnel (820.25)
  • Design Controls (820.30)
  • Document Controls (820.40)
  • Purchasing Controls (820.50)
  • Identification (820.60)
  • Traceability (820.65)
  • Production and Process Controls (820.70)
  • Inspection, Measuring and Test Equipment (820.72)
  • Process Validation (820.75)
  • Receiving, In-Process, and Finished Device Acceptance (820.80)
  • Acceptance Status (820.86)
  • Nonconforming Product (820.90)
  • Corrective and Preventive Action (820.100)
  • Device Labeling (820.120)
  • Device Packaging (820.130)
  • Handling (820.140)
  • Storage (820.150)
  • Distribution (820.160)
  • Installation (820.170)
  • Records - General (820.180)
  • Device Master Record (820.181)
  • Device History Record (820.184)
  • Quality System Record (820.186)
  • Complaint Files (820.198)
  • Servicing (820.200)
  • Statistical Techniques (820.250)

The Arbour Advantage

Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.