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Electronic Records and Signatures: Compliance in the 21st Century
Data integrity is crucial to assuring reliable data. For that reason, PTL has considered and implemented systems that ensure information and data security, integrity, and compliance. 21 CFR Part 11[1] is the key guidance for handling electronic records
OOS Investigations at the Contract Lab
Out of specification (OOS) results are bound to occur at a testing laboratory. It is important that your contract lab investigates the unexpected results in a timely and thorough way. An OOS result occurs when an analytical result
Three Things Your Particle Size Contract Lab Needs to Know to Match Your Specifications
Particle size specifications are designed to ensure raw ingredients and products perform as expected. Often, companies are required to verify that their material is meeting these specifications regardless of which supplier is used. Using a contract lab for
What Is Method Validation and Might You Need It?
By Shane Hill Confidence, reliability—ultimately peace of mind. In short, this is the takeaway following an analytical test method validation. Do you work in pharmaceuticals, cosmetics, or the environmental realm? All of these fields, and more, benefit greatly
Choosing Particle Characterization Contract Analysis Services
As more companies and institutions turn to outsourced science for research and development, more options are becoming available for contracted laboratory analysis services. With a wider range of choices, comes a wider range of quality and service. When
Top 3 Reasons a Commercial Lab Can Get Pharma to Market Faster
You’re low on time or resources, particularly when you need a specific instrument for a specific job. As not all instruments can do any test, you need a specific test that requires a specific instrument with a validated
PTL Quality Assurance Launches New Remote Audit Offering
PTL is a proven cGMP compliant laboratory, in accordance with 21 CFR, Part 210, 211, and Part 11. Our facility is FDA registered and inspected, and we host over 30 audits per year from the world’s largest pharmaceutical
PTL now offering USP 788, USP 789 and USP 787 Testing
Particle Technology Labs is pleased to announce we are now offering USP <788> Particulate Matter in Injections testing, USP <789> Particulate Matter in Ophthalmic Solutions testing, and USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections testing. Parenteral
Methods Validation, Verification and Transfer with Particle Technology Labs
What is a method validation? Should my method be verified? What scope of testing should be included in my method transfer? These are just some of your questions. Let Particle Technology Labs help with the answers. PTL is