A library is an integral part of any community. They provide information and resources. So why not one in qmsWrapper, more than storage it’s a favorite place to keep important documents that need to be accessed by all. For example, standards, marketing documents, graphics used…
The QMS documentation – especially for a complex project – can be endless and impenetrable. All of us are familiar with the pain of trying to make order out of complete file chaos, or the vain hope of finding a particular document in a pile…
Data loss or damage is costly, extremely risky and can affect your brand reputation. Perils might come in many forms, as natural disasters (e.g. hurricanes, floods, fire) or uncontrollable human errors, power surges, technical malfunctions and increasingly malware attacks. You need a backup plan and…
Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier, while incorrect documentation will bring you nothing but trouble. Use qmsWrapper to structure your QMS documentation, follow the necessary steps and avoid those unpleasant last-minute…
Today’s businesses are up against more challenges than ever in the past. While some businesses think they don’t need to move away from paper, getting started with this practice has never been so crucial. Document management software makes it easy for businesses to combine paper and digital…
In today’s modern world there is no space for time-wasting. The challenge of time was best expressed by William Penn when he said, “Time is what we want most, but what we use worst”. Managing time in a fast-growing business world requires serious sets of skills…
Successful startups and small businesses understand that although a DMS (Document Management Software) is essential to success it is outright critical for compliance. The top features requested in DM software reflect the growing needs of Startups and Small companies who cannot ignore the increasingly central role a DMS…
ISO 12651-2 defines a document as “recorded information or object which can be treated as a unit”. Err… Yup!… Got it!… Been treating recorded objects as a unit for, well… forever… Sometimes you just have to admire their creativity! Compliance requests essentials On the more…
Document management is where a medical device quality system either stays audit-ready or slowly falls apart. ISO 13485:2016 Clause 4.2.3 requires controlled documents, Clause 4.2.4 requires controlled records, FDA 21 CFR Part 820.40 sets the same expectation for document controls, and EU MDR technical documentation…
Document control is the foundation auditors examine first. For medical device companies under ISO 13485, FDA 21 CFR Part 820, or EU MDR, the way your SOPs, design records, and quality documents are versioned, approved, and retrieved is often the deciding factor between a clean…
