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Regulatory
As a business enterprise with concern for both the bottom line and patient and consumer safety, it’s reassuring to organizations to know that meeting standard compliance needs does not have to be a costly process. These Industry Regulation White Papers provide a concise look at those specific subparts of each regulation that can be supported through cost-effective automation to ensure a manufacturer’s compliance. Request one or all of our NEW Industry Regulation White Papers now!
Documents
21 CFR Part 11 White Paper
The FDA has created several documents with the assistance of industry representatives, to offer guidance in interpretation of the requirements. Even with these efforts, the requirements are still somewhat of a moving target. Pilgrim Software is continuously monitoring the opinions of the FDA to ensure continued compliance with the requirements.
This document presents the requirements set forth in 21 CFR Part 11, along with Pilgrim Software's own interpretation of the requirements.
Applicable Industry: Life Sciences, Biologics, Medical Device, Pharmaceutical, FDA-Regulated
Applicable Solution: All
21 CFR Part 1270-1271 White paper
Applicable Industry: Tissue
Applicable Solution: All
21 CFR Part 210-211 White Paper
21 CFR Part 210-211, also known as, Current Good Manufacturing Practices (CGMP) in Manufacturing, Processing, Packing or Holding of Drugs (210); CGMP for Finished Pharmaceuticals (211): require that all drugs are compliant with the latest GMPs. The regulations ensure that drug products meet regulatory requirements as to safety, strength, quality and purity. This whitepaper shows how Pilgrim's solution can help companies comply with Part 210-211.
Applicable Industry: Biologics, Pharmaceutical
Applicable Solution: All
21 CFR Part 606 White Paper
21 CFR Part 606, also known as, Current Good Manufacturing Practice (CGMP) for Blood and Blood Components, outlines requirements for blood labeling, laboratories, reporting and recordkeeping. It is meant to ensure that blood and blood components for human use are safe, pure and effective. This whitepaper shows how Pilgrim's solution can help companies comply to Part 606.
Applicable Industry: Blood
Applicable Solution: All
21 CFR Part 820 White Paper
This Industry Regulation White Paper provides a concise look at those specific subparts of 21 CFR Part 820 for Medical Device companies that can be supported through cost-effective automation to ensure a manufacturer's compliance.
Applicable Industry: Medical Device
Applicable Solution: All