Your Shopping Cart
By using this site you agree to our use of cookies. Please refer to our privacy policy for more information. Close
Hello. Sign In
Your Account

Log In to ComplianceOnline
Welcome back! Please log in below to continue.
0
Cart
Toll Free:
+1-888-717-2436
+1-888-717-2436
Industries
- Banking & Financial Services
- BANKING & FINANCIAL SERVICES
- Banks and Credit Unions
- Financial Services and Trading
- Insurance
- Accounting and Taxation
- Life Sciences
- Hitech, Aero & Manufacturing
- HITECH, AERO & MANUFACTURING
- Quality & Safety
- Standards and Methodology
- Energy & Utilities
- ENERGY & UTILITIES
- IT Security
- Reliability (NERC / FERC)
- Quality and Safety
- Risk Management
- CPG & Retail
- CPG & RETAIL
- Retail Audit
- Quality & Safety
- Social Compliance
- Healthcare
- Food & Dietary Supplements
- Cross Industry Functions
Webinars
By Industries
Seminars
Quality Control Laboratory Compliance - cGMPs and GLPs
Process Validation Guidance Requirements (FDA and EU Annex 15: ...
FDA Recalls - Before You Start, and After You Finish
Biostatistics for the Non-Statistician
Data Integrity: FDA/EU Requirements and Implementation
Managing Domestic and Foreign FDA Inspections and the ...
Recordkeeping and Documentation in a GLP Laboratory ...
Reduce costs for compliance with data integrity: 21 CFR Part 11 ...
Change Control Best Practices - Avoiding Unintended ...
Technical Writing for Pharma, Biotech and Medical Devices
Standards
Aerospace
Agriculture and Farm Machinery
Automotive, Aircraft & Marine technology
Banking, Corp. finance & Sox
Biotech & Pharmaceutical Standards
Chemical technology
Civil engineering and construction
Computer Hardware
Electrical Engineering
Electronic Equipment
ANSI
Audit Net
BIN
BPA
Business Basics
Complianceonline
IT Governance
LabCompliance
Quality-Control-Plan
RCGLOBAL
SHOQ Quality Assurance Manuals
SEPT
Home
› Best Practices
Biotech Quality Software
- Date: February 18, 2011
- Source: Admin
Regulations
Current Good Manufacturing Practice (CGMP) |
21 CFR Parts 210 and 211 |
CDER CGMP Regulations and Controls Used for Manufacturing, Processing, Packing, or Holding Drugs Contain the minimum CGMP for methods to be used in - and the facilities or controls to be used for - the manufacture, processing, packing, or holding of drug products to ensure that they meet regulatory requirements as to safety and strength, quality, and purity. |
Electronic Record-Keeping Systems Requirements |
21 CFR Part 11 |
Developed to set standards for systems containing electronic records and electronic signatures. Validation of the system used within its current operating environment. “Persons must still comply with all applicable predicate rule requirements for validation (e.g., 21 CFR 820.70(i)).” “We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety and record integrity.” “For further guidance on validation of computerized systems, see FDA’s Guidance for Industry and FDA Staff CDRH “General Principles of Software Validation” and industry guidance such as the “GAMP4 Guide for Validation of Automated Systems”. |
GAMP4 |
|
Widely used, internationally accepted, guideline for validation of computer systems. GAMP Guide is produced by ISPE and the GAMP Forum. |
Additionally, manufacturers in the Biotechnology industry need to meet regulatory requirements set by the FDA and other regulatory bodies, including the National Institutes of Health (NIH), and the Occupational Safety and Hazard Administration (OSHA).
Guidance: FDA
Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance |
Regulatory framework (Process Analytical Technology to encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. |
General Principles of Software Validation |
General validation principles considered to be applicable to the validation of medical device software or software used to design, develop, or manufacture medical devices. |
Risks of noncompliance
FDA regulatory action: The agency will consider regulatory action with respect to Part 11 when the electronic records or electronic signatures are unacceptable substitutes for paper records or handwritten signatures, and therefore, requirements of the applicable predicate regulations (e.g., CGMP and Medical Device QSR regulations) are not met. The agency issues warning letters.
Source
http://www.fda.gov/downloads/Drugs/guidancecomplianceregulatoryinformation/guidances/ucm070305.pdf
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf
http://www.thecomplianceauthority.com/compliance-whitepapers/risk-of-noncompliance.pdf
Compliance Trainings

Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
On Demand Access Anytime
By - Christopher W. Olmsted
On Demand Access Anytime

How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime

Compliance Standards
Best Sellers
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
By: Miles HutchinsonAdd to CartPrice: $249
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
San Francisco, CA | Aug 6-7, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 18-19, 2020
-
Los Angeles, CA | Aug 20-21, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 25-26, 2020
-
Virtual Seminar | Jun 10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | Jul 6-7, 2020
-
San Francisco, CA | Oct 22-23, 2020
-
Virtual Seminar | Jul 9-10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | June 3-4, 2020
-
Miami, FL | Jul 29-31, 2020
-
Virtual Seminar | Jun 17, 2020
-
Provider: ANSIAdd to CartPrice: $142
- Add to Cart
- Add to Cart
- Add to Cart
-
Provider: ANSIAdd to CartPrice: $120
-
Provider: ANSIAdd to CartPrice: $250
-
Provider: SEPTAdd to CartPrice: $299
- Add to Cart
-
Provider: Quality-Control-PlanAdd to CartPrice: $37
- Add to Cart
-
Provider: At-PQCAdd to CartPrice: $397
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
You Recently Viewed
