| When it comes to quality control (in FDA regulated | | | | discredits paper and takes document control online. |
| environments) and the implementation of quality | | | | Not only will you save money (in the long run) |
| related findings, successful performance is often | | | | you’re your |
| determined by two factors: | | | | quality-control-is-my-worst-nightmare ulcer will |
| | | | dissipate like dew in the morning. Look for a quality |
| 1. Whether or not managers and employees really | | | | control system that will automate repetitive |
| concern themselves with superior quality standards, | | | | processes. Whether those processes consist of |
| AND | | | | routing, approval, archiving, editing, etc. find a solution |
| 2. Whether or not the company in question has | | | | that works for you. Find a solution that gives you |
| access to the right technological solutions. A New | | | | more time to think about the aspects of your |
| State of Quality Control | | | | business that are really important. |
| 25 years ago--even 15 years ago--quality control | | | | A Quality Control System Should Consist of Parts |
| consisted of menial tasks that were managed by | | | | that Integrate |
| people. Like many menial tasks however, those | | | | A quality control system shouldn’t consist of |
| quality control, rote to-do lists can now be managed | | | | document control alone but it shouldn’t |
| by the levelheaded computerized technology we | | | | overburden you with 35+ varied quality control |
| have all come to rely on more than we do on our | | | | solutions that you have to use for the benefit of |
| own mothers. | | | | your company’s sanity (yeah right!). Look for |
| Yes. Technology has done it again. | | | | a system that allows you to select the solutions that |
| However, it is unfortunate that many of the right | | | | your company needs and make sure those solutions |
| people have not been introduced to the right | | | | can be integrated into one streamlined system. For |
| technological solutions. For instance, life science | | | | instance, you may want a system that controls |
| (biotech, pharmaceuticals, medical device, etc.) and | | | | quality and compliance documentation, deviations, |
| high-tech professionals whose employees continue to | | | | customer complaints, CAPA (corrective and |
| fumble over quality control processes that plod at a | | | | preventative actions), equipment calibration, change |
| sluggish pace and are inevitably error-prone are very | | | | control and training procedures. If that’s |
| often oblivious to the fact that their paper-based and | | | | enough for your company, find the software |
| hybrid controlled quality systems are debilitating | | | | provider that will proffer those solutions. No more. No |
| every extant project and department within their | | | | less. |
| respective companies. If they would take a | | | | A Quality Control System Should Include Training and |
| comparatively small amount of time to find the right | | | | Additional Services |
| quality control solution(s), they could not only dilate | | | | Software without training is like a can of olives |
| their production and accuracy but could, in addition, | | | | without a can opener (i.e. very frustrating). Look for |
| relieve their employees who suffer from the | | | | a quality control system that includes not only |
| constant humdrum of menial and repetitive | | | | training, but validation services (see below), technical |
| paper-based quality management tasks. These | | | | support and of course---implementation. |
| employees, with the right technological booster, could | | | | Quality Control Solutions Should Afford Validation |
| actually produce real results. | | | | Services |
| So, if you are a life science or high-tech professional | | | | According to the FDA’s CFR 21 Part 11 |
| and are considering the escalade of your quality | | | | regulation, quality control software solutions must be |
| control system, take the following into account: | | | | validated. Validation can be time consuming (especially |
| A Quality Control System Should Control | | | | if you are raring to utilize your new system), so |
| Documentation | | | | when you look for a quality control system, look for |
| Whether your company routes design files like rain | | | | a provider that provides the system and validation |
| falls in the Amazon, or you deal mostly with | | | | services. |
| calibration or audit forms, quality control relies heavily | | | | There are many more factors that should be |
| on documentation. In addition, if compliance (i.e. FDA, | | | | considered when upgrading or “first-time |
| ISO, CLIA, EMEA, SOX, etc.) is to be controlled | | | | purchasing” a quality control system. Start by |
| simultaneously regulated documents must be | | | | considering your needs. User requirements should be |
| controlled simultaneously with paralleled quality | | | | the basis for every purchase. |
| processes. Look for a quality control system that | | | | |