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Quality Control Standards: Life Science and High-tech Professionals Should Know What They are Missing

When it comes to quality control (in FDA regulated environments) and the implementation of quality related findings, successful performance is often determined by two factors:

1. Whether or not managers and employees really concern themselves with superior quality standards, AND
2. Whether or not the company in question has access to the right technological solutions.

A New State of Quality Control

25 years ago–even 15 years ago–quality control consisted of menial tasks that were managed by people. Like many menial tasks however, those quality control, rote
to-do lists
can now be managed by the levelheaded computerized technology we have all come to rely on more than we do on our own mothers.

Yes.
Technology has done it again.

However, it is unfortunate that many of the
right
people have not been introduced to the
right
technological solutions. For instance, life science (biotech, pharmaceuticals, medical device, etc.) and high-tech professionals whose employees continue to fumble over quality control processes that plod at a sluggish pace and are inevitably error-prone are very often oblivious to the fact that their paper-based and hybrid controlled quality systems are debilitating every extant project and department within their respective companies. If they would take a comparatively small amount of time to find the right quality control solution(s), they could not only dilate their production and accuracy but could, in addition, relieve their employees who suffer from the constant humdrum of menial and repetitive paper-based quality management tasks. These employees, with the right technological booster, could actually produce
real
results.

So, if you are a life science or high-tech professional and are considering the escalade of your quality control system, take the following into account:

A Quality Control System Should Control Documentation

Whether your company routes design files like rain falls in the Amazon, or you deal mostly with calibration or audit forms, quality control relies heavily on documentation. In addition, if compliance (i.e. FDA, ISO, CLIA, EMEA, SOX, etc.) is to be controlled simultaneously regulated documents must be controlled simultaneously with paralleled quality processes. Look for a quality control system that discredits paper and takes document control online. Not only will you save money (in the long run) you’re your quality-control-is-my-worst-nightmare ulcer will dissipate like dew in the morning. Look for a quality control system that will automate repetitive processes. Whether those processes consist of routing, approval, archiving, editing, etc. find a solution that works for you. Find a solution that gives you more time to think about the aspects of your business that are really important.

A Quality Control System Should Consist of Parts that Integrate

A quality control system shouldn’t consist of document control alone but it shouldn’t overburden you with 35+ varied quality control solutions that you
have to
use for the benefit of your company’s sanity (yeah right!). Look for a system that allows you to select the solutions that your company needs and make sure those solutions can be integrated into one streamlined system. For instance, you may want a system that controls quality and compliance documentation, deviations, customer complaints, CAPA (corrective and preventative actions), equipment calibration, change control and training procedures. If that’s enough for your company, find the software provider that will proffer those solutions. No more. No less.

A Quality Control System Should Include Training and Additional Services

Software without training is like a can of olives without a can opener (i.e. very frustrating). Look for a quality control system that includes not only training, but validation services (see below), technical support and of course—implementation.

Quality Control Solutions Should Afford Validation Services

According to the FDA’s
CFR 21 Part 11 regulation
, quality control software solutions must be validated. Validation can be time consuming (especially if you are raring to utilize your new system), so when you look for a quality control system, look for a provider that provides the system and validation services.

There are many more factors that should be considered when upgrading or “first-time purchasing” a quality control system. Start by considering your needs. User requirements should be the basis for every purchase.
About the Author

Marci Crane is a copywriter for MasterControl in Salt Lake City, UT. For more information in regards to streamlined quality control, feel free to contact a MasterControl representative.

Top Quality & 3rd Eye – What?

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Retin A Cream (Tretinoin) 0.025% 45.00 $27 Chemical Name: TRETINOIN (TRET-i-noyn)Retin A is a vitamin A derivative used to treat acne. It may also be used to treat other conditions as determined by your doctor.

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Depo-Medrol 40mg 5mL 1.00 $39.99 DEPO-MEDROL may be used to treat a wide variety of conditions. It can be used to replace cortisone in people who are deficient in cortisone. It can also be used to treat a number of other conditions, including respiratory diseases (such as asthma), skin diseases, severe allergies, certain eye diseases, rheumatoid arthritis, inflammatory bowel disease, certain blood disorders, and certain types of cancer. In all of these conditions, inflammation plays a part in causing disease. This medication works by reducing inflammation. It is used when steroid tablets taken by mouth are not appropriate. It may sometimes be injected directly into its site of action, such as a joint or a lesion.

Anthelios (with Mexoryl) SPF 60 XL Fluid extreme Cream (SPF 50+ in EU) 50.00 $27 SPF 30 Sun Block Lotion: High protection from UVA and UVB rays thanks to a filtering system Mexoryl SX (patented sunscreen) in order to prevent sunburn. The liberal and regular use of this product over the years may help reduce the chance of premature aging of the skin. Texture extremely resistant to water and sweat for a strengthened protection, even during outdoor sports, excessive perspiration, water sports and frequent bathing. Its water in oil formulation with moisturizing properties prevents skin dryness even under extreme conditions. Non-comedogenic. SPF 30 Spray: High protection from UVA and UVB rays thanks to a filtering system Mexoryl SX (patented sunscreen) in order to prevent sunburn. The liberal and regular use of this product over the years may help reduce the chance of premature aging of the skin. Texture extremely resistant to water and sweat for a strengthened protection, even during outdoor sports, excessive perspiration, water sports and frequent

LAC-HYDRIN 12% 12% Cream 140.00 $15.49 This medicine is an emollient used to treat dry, scaly skin and to relieve the itching that goes with this condition.

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Orthovisc 2ml 3.00 $225 ORTHOVISC is a safe treatment for the condition of osteoarthritis. ORTHOVISC is injected directly into the patients knee by a doctor to improve the lubrication of the joint and to provide pain relief. We offer highly competitive pricing on ORTHOVISC. Ask about quantity discount pricing when ordering ORTHOVISC.ORTHOVISC is a viscous (thick) sterile mixture made from highly purified hyaluronan dissolved in saline. Hyaluronan is a natural chemical found in the joint fluid of your body. The bodys own hyaluronan acts like a lubricant and a shock absorber in the joint. It is needed for the joint to work properly. ORTHOVISC is ultra-pure hyaluronan, which contains no buffers or preservatives. ORTHOVISC contains the highest concentration of hyaluronan available per injection.

Botoina Eye Cream 5000 15.00 $95 Wrinkles and lines are the first visible signs of aging. Usual options of reducing its appearance are surgery or injected fillers. But now, a new wonder product in the market claims to reduce wrinkles with external application. This revolutionary product, Botoina, is available in serum form and tests have proved the efficacy and safety of the product. The best thing about this product is that it can be used at home easily.Cosmetic preparation suitable for very deep expression lines and expression aging. Botoina is the trade name of a complex of 4 molecules of cosmetic use. When applied with precision directly on the furrows of the wrinkles. Botoina has a smoothing effect on expression lines. The preparation is applied cutaneously at home using a precision graduated applicator with a truncated tip. Method of applying Botoina combines, for the first time, a cosmetic precision applicator, a truncated tip for external application and a cosmetic preparation which, thanks to these in

Ombrelle (with Mexoryl) SPF 60 Protection Milk (4.02oz) 120.00 $19 SPF 15 Lotion: Can be used daily, all year around on the face, body and hands. Light in texture providing photostable protection throughout the UVA/UVB spectrum. Fragrance and colorant free, moisturizing, non-greasy and water-resistant. SPF 30 Lotion: Can be used daily, all year around on the face, body and hands. This moisturizing and gentle lotion is an effective protection for people who plan to stay outdoors for an extended period of time. Provides photostable protection throughout the UVA/UVB spectrum. Fragrance and colorant free, moisturizing, non-greasy and water-resistant. SPF 30 Extreme Lotion: Best suited for hot days and where there is strong sun reflection. For people who engage in very active outdoor activities, extreme lotion SPF 30 combines the effectiveness of active ingredients such as Parsol 1789, Mexoryl SX, micronized titanium dioxide (a physical sunblock). Fragrance and colorant free, moisturizing, non-greasy and water-resistant

Revanesse 1ml 2.00 $249 Revanesse is a new biodegradable non-animal based clear Hyaluronic acid gel. Revanesse is best used to fill superficial imperfections in the dermis, such as fine lines, forehead wrinkles, crow’s feet, perioral lines, small nasolabial folds, and glabeller lines. Revanesse will naturally break down in your body after 6 months without leaving any harmful by-products.1ml of Revanesse contains: 25 mg Stabilised Hyaluronic Acid

Anthelios (with Mexoryl) SPF 60 XL Tinted Cream (1.69oz) 50.00 $21 SPF 30 Sun Block Lotion: High protection from UVA and UVB rays thanks to a filtering system Mexoryl SX (patented sunscreen) in order to prevent sunburn. The liberal and regular use of this product over the years may help reduce the chance of premature aging of the skin. Texture extremely resistant to water and sweat for a strengthened protection, even during outdoor sports, excessive perspiration, water sports and frequent bathing. Its water in oil formulation with moisturizing properties prevents skin dryness even under extreme conditions. Non-comedogenic. SPF 30 Spray: High protection from UVA and UVB rays thanks to a filtering system Mexoryl SX (patented sunscreen) in order to prevent sunburn. The liberal and regular use of this product over the years may help reduce the chance of premature aging of the skin. Texture extremely resistant to water and sweat for a strengthened protection, even during outdoor sports, excessive perspiration, water sports and frequent

Lustra Cream (Hydroquinone Topical) 2% AF SPF15 30g 1.00 $23.99 Lustra is a skin bleaching agent used to temporarily lighten the skin.Lustra comes in a squeeze tube.

Retin A Cream 45.00 $27 This medicine is a vitamin A derivative used to treat acne. It may also be used to treat other conditions as determined by your doctor.

Restylane 0.5ml 1.00 $120 RESTYLANE injections are used to treat facial wrinkles, folds and lip augmentations. RESTYLANE is an injection treatment.RESTYLANE is a crystal-clear, biodegradable NASHA (Non-Animal Stabilized Hyaluronic Acid) gel, which is injected into the dermis in tiny amounts with a very fine needle. The result is instantaneous, producing a long-lasting, natural enhancement that is gentle and safe to the skin.

Botoina Intensive 1000 1.00 $110 Wrinkles and lines are the first visible signs of aging. Usual options of reducing its appearance are surgery or injected fillers. But now, a new wonder product in the market claims to reduce wrinkles with external application. This revolutionary product, Botoina, is available in serum form and tests have proved the efficacy and safety of the product. The best thing about this product is that it can be used at home easily.Cosmetic preparation suitable for very deep expression lines and expression aging. Botoina is the trade name of a complex of 4 molecules of cosmetic use. When applied with precision directly on the furrows of the wrinkles. Botoina has a smoothing effect on expression lines. The preparation is applied cutaneously at home using a precision graduated applicator with a truncated tip. Method of applying Botoina combines, for the first time, a cosmetic precision applicator, a truncated tip for external application and a cosmetic preparation which, thanks to these in