Category Archives: Data Integrity

Software Development Life Cycle (SDLC) is a process used by the software industry to design, develop and test high quality software. The SDLC aims to produce a high-quality software that meets or exceeds customer expectations, reaches completion within times and cost estimates. The software life cycle model that is selected should cover from its birthContinue reading “SDLC Approaches, Deliverables & Regulatory Expectation”

FDA’s Center for Devices and Radiological Health (CDRH) released its FY 2020 draft and final guidance list, which features a few repeats from last year and new drafts coming on device servicing and remanufacturing, unique device identification and patient-reported outcome measures used in device submissions, among others. As in years past, CDRH divides the listContinue reading “New FDA validation approach from Traditional CSV to CSA (Computer Software Assurance).”

‘If it’s not written down, then it didn’t happen!’ Documentation is important because the accurate capture of information plays an vital role in the pharmaceuticals and medical device industry. Documents are a Mirror to show actual image of any pharmaceutical company. Documents and products are produced in pharmaceuticals but regulatory bodies are interested to seeContinue reading “Importance of Documentation in Pharmaceutical Industry”

Many pharma companies still use “hybrid systems” combining paper and electronic records: an electronic instrument is used to print results on paper. Hybrid System – an environment consisting of both Electronic & paper-based Records (frequently characterized by handwritten signatures Executed on paper). An example of hybrid system is the one in which the system userContinue reading “What is Hybrid System ?”

Open vs Closed System Open vs. Closed is one of the trickiest parts of the regulations, especially because the definitions provided by the FDA in Part 11 are different from those understood by the IT industry at large. The open or closed portion turns on whether you as an organization have complete control over people accessing theContinue reading “What is Open vs Closed System, Its Controls & Requirements”

Let’s be honest: No one really likes legacy systems. Most legacy setups at companies happen because something else goes wrong – there’s a compliance issue, or a rollout is too difficult to do all at once, or ongoing projects require older software/hardware…or decision makers who just don’t like change What is Legacy system? Legacy system is an old method, technology, computerContinue reading “Legacy Systems & Its Challenges in Pharmaceutical Industry”

What is Software? Use of Software as a Medical Device is continuing to increase.  It can be used across a broad range of technology platforms, including medical device platforms, commercial “off-the-shelf” platforms, and virtual networks, to name a few. Such software was previously referred to by industry, international regulators, and health care providers as “standaloneContinue reading “Brief on what is Software, its categorization & GAMP 5 in Pharmaceutical Industry”

Static Record: A static record format, such as a paper or electronic record, is one that is fixed and allows little or no interaction between the user and the record content. Static record is used to indicate a fixed-data record such as a paper record or an electronic image. Static data is data that doesContinue reading “Static & Dynamic Record”

Handwritten Signature: A scripted name or legal mark created by an individual that is unique to that individual and is used to authenticate something in writing. The act signing with writing or marking instrument is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices thatContinue reading “What is Electronic Signature?”

Background: On March 20, 1997, FDA published a final rule on electronic records and signatures a document that will have a profound effect on device companies. This rule (21 CFR 11) establishes the criteria under which FDA will deem electronic records and electronic signatures equivalent to paper records and traditional handwritten signatures.  If electronic signaturesContinue reading “What is Electronic Record ???”